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Center for Substance Abuse Treatment. Incorporating Alcohol Pharmacotherapies Into Medical Practice. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2009. (Treatment Improvement Protocol (TIP) Series, No. 49.)

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Incorporating Alcohol Pharmacotherapies Into Medical Practice.

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Chapter 6—Patient Management

Integrating Medication for Alcohol Dependence Into Clinical Practice Settings

Pharmacotherapy for alcohol use disorders (AUDs) is underused both in specialized substance abuse treatment programs and in office-based medical practice. The consensus panel acknowledges that much resistance to pharmacotherapy exists—from third-party payers, some clinicians, some individuals participating in self-help groups who view medications as substituting a pill for self-empowerment and self-responsibility, and some patients and their families. The diagnoses of alcohol dependence and abuse, as well as hazardous alcohol use, continue to carry significant social stigma that affects both the person who is alcohol dependent and healthcare providers. This stigma continues to exist, in part, because of a lack of understanding of alcohol dependence as a treatable medical disorder. In addition, providers often worry that persons who are alcohol dependent have complicated conditions that take too much time to treat.

Healthcare providers are, however, in ideal practice settings to identify and treat AUDs among users of healthcare services. AUDs are associated with many medical (e.g., hypertension, gastritis) and behavioral (e.g., major depressive disorder, psychoses) health conditions. Screening, identifying, and treating patients with AUDs have the potential to improve the health of many primary care patients, decrease healthcare costs, and prevent the serious sequelae of alcohol misuse. A full discussion of reimbursement issues is outside the scope of TIP 49; however, healthcare practitioners can find useful information in SBI Reimbursement Guide: How to Use Existing Codes to Bill for Alcohol Screening and Brief Intervention/Counseling, prepared by Ensuring Solutions for Alcohol Problems at the George Washington University Medical Center. The guide is available at http://www.ensuringsolutions.org/resources/resources_show.htm?doc_id=385233.

Patients with AUDs may be more likely to see a healthcare provider than to seek treatment at a specialty addiction treatment program; these patients represent an untapped reservoir of individuals who are not receiving needed treatment. Medications can be a potent means of enhancing treatment for many persons who are alcohol dependent; medications present healthcare providers a unique way to contribute to treatment. Some aspects of using maintenance medications (e.g., the need for concurrent psychosocial treatment and for monitoring drinking behavior) may seem different from usual medical practice. However, integrating maintenance medications into practice should not present any more difficulty than, for example, beginning to prescribe antidepressant or antihypertensive medications. Monitoring a patient's maintenance medication regimen is typically less complicated than medication regimens for other chronic conditions, such as diabetes or coronary disease.

Healthcare providers may find that using maintenance medication provides them with an opportunity to have a significant effect on patients' overall health status, social functioning, and family relationships. This chapter describes information needed for choosing maintenance medications for patients, making effective referrals, and monitoring patients' progress.

Initial Assessment

Persons with AUDs often have physical and social sequelae from excessive alcohol consumption. AUDs influence the incidence, course, and treatment of many medical and behavioral health conditions. Identifying, assessing, and treating AUDs can occur concurrently with assessment and treatment of other medical problems. As noted in Chapter 1, a thorough discussion of screening and assessment for AUDs is outside the scope of this TIP. The reader can refer to Helping Patients Who Drink Too Much: A Clinician's Guide (National Institute on Alcohol Abuse and Alcoholism [NIAAA], 2006), available at http://www.niaaa.nih.gov. An online course (worth one continuing medical education unit) based on the guide is also available at http://www.niaaa.nih.gov/Publications/EducationTrainingMaterials/VideoCases.htm. NIAAA's A Pocket Guide for Alcohol Screening and Brief Intervention is in Appendix B of this TIP.

Once an AUD diagnosis has been made, thorough assessments for substance use and social, medical, and psychiatric histories are essential in evaluating the consequences of dependence and identifying problems that can be addressed concurrently with treatment. Evaluation can identify or rule out contraindications to therapy with specific medications. At the very least, a clinician considering a patient's pharmacologic treatment for alcohol dependence should perform a physical exam; order laboratory tests; assess psychiatric status; obtain substance use, treatment, and social histories; and assess motivation for change.

Physical Exam and Laboratory Testing

Because alcohol dependence can harm many organ systems and certain conditions may preclude pharmacotherapy with a particular maintenance medication, a physical exam and laboratory testing should be performed before any treatment is initiated.

Medical complications of excessive alcohol consumption are common and numerous, and this TIP cannot discuss them all. However, common medical conditions such as hypertension and gastritis and common psychiatric conditions such as depression can be incited or exacerbated by AUDs. Various patient complaints can be related to alcohol consumption, including dyspepsia, sleep problems, sexual difficulties, depressed mood, and irritability. AUDs also contribute to progression of morbidity for many diseases. For instance, according to a recent review of the literature (Conigliaro, Justice, Gordon, & Bryant, 2006), excessive alcohol consumption increases the morbidity associated with HIV and viral hepatidies and can complicate medical treatment for these conditions. In addition, existing conditions, such as hepatic or renal disease or pain syndromes, either acute or chronic, may contraindicate treatment with particular maintenance medications.

Physical exam

Although physical exam findings may not be specific to alcohol consumption or alcohol disorders, a thorough physical exam can often corroborate clinician suspicions of an AUD and may help with disease monitoring. Patients with AUDs may have no specific abnormal exam findings. However, when present, abnormal exam findings provide evidence of the severity of a patient's AUD. Longstanding alcohol consumption may present with many “classic” physical exam features, including physical manifestations of cirrhosis, encephalopathy, and vitamin deficiencies. Alcohol consumption can incur tachycardia (including supraventricular tachycardias), tremor (hand or tongue), elevated blood pressure, hepatosplenomegaly, a tender liver edge, peripheral neuropathy, spider angiomata, conjunctival injection, and unexplained trauma (Conigliaro, Delos Reyes, Parran, & Schulz, 2003).

Because AUDs often co-occur with drug use, the physical exam may help the clinician identify comorbid substance use problems. For example, smoking cigarettes frequently co-occurs with excessive alcohol use; smoking, along with alcohol use, may increase heart rate and promote tachyarrhythmias. Needle marks, hard blackened veins, and abscesses in the arms, hips, buttocks, thighs, or calves may indicate concomitant injection drug use. Inhaled drugs, such as crack cocaine, often cause a brown tongue, nasal septum abnormalities, or diffuse wheezes.

Laboratory testing

In addition to helping healthcare practitioners assess a patient's overall health status, initial laboratory testing can identify the presence of AUDs, alcohol-related damage, and contraindications for use of particular medications. Initial and followup laboratory testing may motivate patients and reinforce their progress in treatment. Exhibit 6-1 provides a list of useful laboratory tests that can identify patients with significant alcohol consumption.

Exhibit 6-1 Useful Laboratory Tests

Breath or blood alcohol tests

Urine toxicology

Gamma glutamyltransferase (GGT)

Liver function tests, including serum aspartate aminotransferase (AST)

Complete blood count

Testing for vitamin deficiencies

Renal function tests: Standard panel for urea (blood urea nitrogen), electrolytes, and serum creatinine

Pregnancy test (women of childbearing age)

Identifying AUDs and illicit drug use. Laboratory tests are more specific than sensitive for detecting alcohol problems, and there is no single laboratory test that is sensitive or specific for AUD diagnoses. Detection of AUDs is improved when laboratory tests are combined with other screening strategies (Escobar, Espi, & Canteras, 1995; Gordon et al., 2001). However, certain tests help healthcare providers identify AUDs and possible alcohol-related abnormalities.

Blood/breath/urine alcohol and toxicological screening. Blood alcohol levels and urine/breath tests for alcohol are useful measures of recent alcohol consumption. They determine acute physical or legal incapacity to do specific tasks. Initial laboratory work also should include a urine toxicology screen to assess for other substances.

Biomarkers for AUDs. Alcohol biomarkers are physiological indicators of alcohol exposure or ingestion and may reflect the presence of an AUD. Although tests such as serum carbohydrate-deficient transferrin (CDT) levels are not often used in primary care practice, some evidence suggests that they might be used to screen for chronic alcohol consumption and to monitor consumption during treatment under certain conditions (Bell, Tallaksen, Try, & Haug, 1994). For example, an increase in CDT over time may suggest an increase in alcohol consumption (Sorvajarvi, Blake, Israel, & Niemela, 1996).

In addition to assessing impairment in liver functioning, AST and GGT can be used as biomarkers because they are often elevated in persons who recently consumed significant amounts of alcohol (Aithal, Thornes, Dwarakanath, & Tanner, 1998; Bell et al., 1994; Yersin et al., 1995). Some studies suggest that biomarkers such as AST, GGT, and CDT are most useful for screening when used in combination (Aithal et al., 1998; Sillanaukee, Aalto, & Seppa, 1998).

Testing for another biomarker, ethyl glucuronide (EtG), is becoming widely available in the United States and is increasingly being used for screening. This marker is highly sensitive for alcohol. This sensitivity is a potential drawback as well as a strength, as exposure to even small amounts (such as those found in some foods and cosmetic items) can trigger a positive test result.

More detailed information about the use (and misuse) of biomarkers for identifying AUDs and other substance use disorders can be found in the Substance Abuse Treatment Advisory, The Role of Biomarkers in the Treatment of Alcohol Use Disorders (Center for Substance Abuse Treatment [CSAT], 2006b).

Identifying alcohol-related damage and medication contraindications. Several laboratory tests help healthcare practitioners establish a patient's overall health status as well as identify alcohol-related damage and contraindications for using certain medications.

Complete blood count. Alcohol overuse causes anemia and has direct toxic effects on bone marrow. An assessment of hematologic laboratory indices is essential when considering pharmacologic treatment of AUDs. Many persons who are alcohol dependent have macrocytosis, and the mean corpuscular volume is often elevated.

Testing for vitamin deficiencies. People with AUDs may not eat well, and several vitamin deficiencies can occur that lead to abnormal cellular functions. Thiamine, folic acid, and pyridoxine deficits are common in people with chronic AUDs, and these deficiencies contribute to abnormal cell growth. Vitamin deficiencies may lead to Wernicke-Korsakoff's/amnestic syndrome in patients with severely excessive alcohol consumption.

Hepatic and renal testing. Consideration of treatment of AUDs with pharmacotherapy requires the clinician to consider evaluating organ systems that are involved in the metabolism and excretion of these medications. For example, naltrexone and disulfiram should be used with caution in patients with liver disease, and naltrexone and acamprosate should be used with caution in patients with renal impairment. Therefore, hepatic and renal system testing should be done before initiating use of these medications. Finally, all four medications used to treat AUDs are U.S. Food and Drug Administration (FDA) pregnancy category C; women of childbearing age should receive a pregnancy test before pharmacotherapy is initiated.

Motivating patients for treatment and reinforcing progress. Providing feedback about patients' initial test results, compared with norms, and the health risks associated with these results can be a powerful way to increase patients' motivation and adherence to treatment. Laboratory tests help healthcare providers objectively monitor patients' progress in treatment and provide patients with objective reinforcement by demonstrating biologic evidence of their improving health status.

Psychiatric Assessment

Psychiatric conditions (such as major depression, generalized anxiety disorder, posttraumatic stress disorder, schizophrenia, and personality disorders) frequently co-occur with excessive alcohol consumption (Kranzler & Rosenthal, 2003). Some psychiatric symptoms resolve with abstinence, and others lessen. Nonetheless, the prescribing professional should assess the patient for these disorders and for suicidal ideation or intent (or refer the patient for assessment). Untreated psychiatric conditions can seriously interfere with a patient's ability to comply with pharmacotherapy and psychosocial treatment for alcohol dependence and can cause the patient preventable suffering. More information on co-occurring psychiatric disorders can be found in TIP 42, Substance Abuse Treatment for Persons With Co-Occurring Disorders (CSAT, 2005).

Substance Use Assessment

After healthcare providers have ascertained that a patient has an AUD, they should obtain an adequate history of the patient's substance use and of prior treatments for AUDs. Providers should determine whether the patient has experienced alcohol withdrawal syndrome because this syndrome can indicate a need for more specialized care than primary care providers can typically provide. More information about alcohol withdrawal and detoxification is in TIP 45, Detoxification and Substance Abuse Treatment (CSAT, 2006a). Excerpts of the Quick Guide for Clinicians based on TIP 45 are in Appendix C.

During the assessment, providers should assess the quantity and frequency of alcohol consumption, patterns of alcohol consumption (e.g., persistent, occasional, binge use), episodes of use, duration of use, and consequences of alcohol consumption. The NIAAA clinician's guide suggests a stepwise approach that consists of assessment of any use, quantity/frequency of use, and harm associated with alcohol consumption (NIAAA, 2006). NIAAA's A Pocket Guide for Alcohol Screening and Brief Intervention, a condensed version of the clinician's guide, is in Appendix B. Exhibit 6-2 lists key questions to quickly assess quantity and frequency of alcohol use, based on a “standard drink” in the United States that contains 14 grams of pure alcohol (about 0.6 fluid ounces or 1.2 tablespoons). More detailed information about what constitutes a standard drink is in Appendix B.

Exhibit 6-2 Questions To Assess Quantity and Frequency of Consumption

How often do you have a drink containing alcohol?

How many drinks containing alcohol do you have on a typical day when you are drinking?

How often do you have five or more drinks on one occasion?

The history also should include use of substances other than alcohol, especially opioids, as well as the patient's history of use, misuse, or abuse of prescription medications. Misuse of opioid medications may complicate or contraindicate treatment with naltrexone. Abuse of sedatives and tranquilizers may complicate detoxification and treatment.

A complete assessment includes a patient's current involvement in or history of professional treatment or mutual-help group involvement, including the following:

  • Detoxification episodes
  • Pharmacotherapy interventions
  • Specialty substance abuse treatment episodes (including when, where, modality, duration, and outcome)
  • Individual therapy
  • 12-Step (e.g., Alcoholics Anonymous) or other mutual- or self-help program involvement.

This information can assist the provider in treatment planning and advocating for psychosocial treatment as an adjunct to pharmacologic treatment for alcohol dependence.

Social History

Understanding a patient's social situation identifies problems that may interfere with treatment and that necessitate referral for ancillary services. Asking a patient basic questions about his or her work, legal, living, and family situations can yield information that is critical to treatment planning:

  • What is the patient's family situation? Who should be included in treatment planning? Who can monitor a patient's medication compliance?
  • Is the patient on probation at work? Could this be a means of motivating medication compliance?
  • What is the patient's living situation? Are extra measures required to ensure medication compliance? Are psychosocial treatment modalities (residential vs. outpatient) recommended?

Assessing Motivation for Change

Before offering treatment for alcohol dependence, providers should assess patients' readiness to change drinking behavior. Through this assessment, patients and providers develop mutually agreeable intervention and treatment plans. Exhibit 6-3 provides questions that determine patients' readiness for change.

Exhibit 6-3 Questions To Assess Patients' Readiness for Change

In what ways are you concerned about your drinking?

How much does this concern you?

What are the reasons you see for making a change?

How do you feel about changing your drinking?

How ready are you to change your drinking?

What do you think will happen if you don't make a change?

What do you think you want to do about your drinking?

What do you think would work for you, if you needed to change?

Regardless of patients' readiness to change, they should, at a minimum, be willing to be in a supportive relationship with their healthcare provider. If the relationship is strained by dishonesty or mistrust, initial willingness to take medication and ongoing compliance with a medication regimen may suffer. In addition, patients should be willing to consider adjunctive options including specialty treatment, other independent psychosocial treatment providers, or forms of community support. A review of the literature suggests that although psychosocial interventions increase rates of abstinence and decrease alcohol consumption, a significant proportion of patients relapse to drinking within 1 year (Mason, 2005a). Healthcare providers, however, can play a significant role in motivational enhancement and relapse prevention. More information about stages of change and motivational enhancement is in TIP 35, Enhancing Motivation for Change in Substance Abuse Treatment (CSAT, 1999b).

Choosing a Medication

Scant research exists to guide clinicians in choosing the best medication for a particular patient. This lack of guidance results in part from the inconsistent findings of pharmacotherapy efficacy trials among subsets of patient populations. These inconsistent results may be related to the multiple factors associated with the effectiveness of these medications. Further research with larger patient samples is necessary before the proposed relationships can have a definitive influence in the individual decisionmaking process.

Each chapter in this TIP that discusses a particular medication for treating AUDs summarizes the evidence that is available regarding the type of patient most appropriate for the medication; a more detailed discussion of patient-medication matching is found in the TIP's online literature review (http://www.kap.samhsa.gov). In addition to considering the characteristics that research has indicated may be relevant to choosing a medication, providers need to consider the patient's:

  • Past experience with particular maintenance medications
  • Opinion about which medication may be most helpful
  • Level of motivation for abstinence
  • Medical status and contraindications for each medication
  • History of medication compliance.

Exhibit 6-4 provides a decision grid to help providers make decisions about pharmacotherapy. This grid is based on existing evidence regarding patient-medication matching, medication contraindications, and the clinical experiences of consensus panelists. Exhibit 6-5 provides a quick-reference guide for comparing maintenance medications.

Exhibit 6-4 AUD Medication Decision Grid

Pretreatment IndicatorsMedications
 Acamprosate (Campral®)Disulfiram (Antabuse®)Oral Naltrexone (ReVia®, Depade®)Injectable Naltrexone (Vivitrol®)
Renal failureXAAA
Significant liver diseaseACCC
Coronary artery diseaseACAA
Chronic painAACC
Current opioid useAAXX
PsychosisACAA
Unwilling or unable to sustain total abstinenceAXAA
Risk factors for poor medication adherenceCCCA
Diabetes that precludes IM injectionACAA
ObesityAAAX
Family history of AUDsAA++
Bleeding/other coagulation disordersAAAC
High level of cravingAA++
Opioid dependence in remissionAA++
History of postacute withdrawal syndrome+AAA
Cognitive impairmentAXAA

A = Appropriate to use

X = Contraindicated

C = Use with caution

+ = Particularly appropriate

Exhibit 6-5 Comparison of Approved Medications for Maintenance of Abstinence From Alcohol*

AcamprosateDisulfiramOral NaltrexoneInjectable Naltrexone
Mechanism of actionNot clearly understood; appears to restore to normal the altered balance of neuronal excitation and inhibition induced by chronic alcohol exposure, possibly through interaction with the glutamate neurotransmitter systemInhibits aldehyde dehydrogenase, causing a reaction of flushing, sweating, nausea, and tachycardia when alcohol is ingestedNot clearly understood; opioid antagonist; blocks the effects of endogenous opioid peptides; appears to attenuate euphoria associated with alcohol use; may make alcohol use less rewarding; may reduce cravingSame as oral naltrexone
Examples of drug interactionsNo clinically relevant interactionsMetronidazole; medications containing alcohol; anticoagulants such as warfarin; amytripyline; isoniazid; diazepamOpioid medications; cough/cold medications; antidiarrheal medications; thioridazine; yohimbinePresumed same as oral naltrexone; clinical drug interaction studies have not been performed
Common side effectsDiarrhea and somnolenceTransient mild drowsiness; metallic taste; dermatitis; headache; impotenceNausea; vomiting; anxiety; headache; dizziness; fatigue; somnolenceSame as oral naltrexone, plus injection site reactions; joint pain; muscle aches or cramps
ContraindicationsSevere renal impairment (creatinine clearance ≤ 30 mL/min)Hypersensitivity to rubber derivatives; significant liver disease; alcohol still in system; coronary artery diseaseCurrently using opioids or in acute opioid withdrawal; anticipated need for opioid analgesics; acute hepatitis or liver failureSame as oral naltrexone, plus inadequate muscle mass for injection; body mass that precludes injection; rash or infection at injection site
CautionsDosage may be modified for moderate renal impairment (creatinine clearance 30–50 mL/min); pregnancy category C Hepatic cirrhosis or insufficiency; cerebrovascular disease; psychoses; diabetes mellitus; epilepsy; renal impairment; pregnancy category C Renal impairment; chronic pain; pregnancy category C Same as oral naltrexone, plus hemophilia or other bleeding problems
Serious adverse reactionsRare events include suicidal ideation; severe persistent diarrheaDisulfiram-alcohol reaction; hepatotoxicity; peripheral neuropathy; psychotic reactions; optic neuritisPrecipitates opioid withdrawal if the patient is dependent on opioids; hepatotoxicity (although it does not appear to be a hepatotoxin at recommended doses)Same as oral naltrexone plus inadvertent subcutaneous injection may cause a severe injection-site reaction; depression; rare events include allergic pneumonia and suicidal ideation
*

Based on information in the FDA-approved product labeling or published medical literature.

FDA pregnancy category C: Animal studies have indicated potential fetal risk OR have not been conducted and no or insufficient human studies have been done. The drug should be used with pregnant or lactating women only when potential benefits justify potential risk to the fetus or infant.

Combination Therapy

A number of studies have found that treatment outcomes improve when naltrexone is combined with acamprosate or disulfiram, particularly for patients who responded poorly to therapy with any of these medications alone (reviewed by Kiefer et al., 2003; Kiefer & Wiedemann, 2004). Besson and colleagues (1998) reported that co-administration of disulfiram improved the action of acamprosate. One study reports that combining acamprosate with naltrexone boosted plasma levels of acamprosate, which may have clinical benefits not achieved by monotherapy with either drug (Mason, 2005a). The Combining Medications and Behavioral Interventions (COMBINE) study (Anton et al., 2006) did not support the efficacy of combination therapy with acamprosate and naltrexone, although this combination has been used in Europe and Australia with some reported success (Feeney, Connor, Young, Tucker, & McPherson, 2006; Kiefer et al., 2003; Kiefer & Wiedemann, 2004). More information is needed about the efficacy of this strategy, although it may be worth trying with patients who have not benefited from single-drug therapy.

One placebo-controlled but not randomized trial of acamprosate also prescribed disulfiram to patients who requested it (Besson et al., 1998). Patients who received the disulfiram-acamprosate combination had significantly more abstinent days than those who received acamprosate only. However, those who requested disulfiram may have been more motivated. Because patients were not assigned randomly to the disulfiram-acamprosate regimen, it is unclear whether the combination of disulfiram and acamprosate or motivation was responsible for the results. Another study (Petrakis et al., 2005) found no advantage for the combination of naltrexone and disulfiram in a randomized, placebo-controlled study of patients with a co-occurring Axis I mental disorder and alcohol dependence, but it did find that active medication with either drug produced greater benefit than placebo in this population.

Although no absolute contraindications exist for using disulfiram with either naltrexone or acamprosate, no clear current evidence indicates that one combination is more efficacious than any of the three agents alone. There is some concern about concurrent use of naltrexone with disulfiram because of the possibility of additive liver toxicity. In addition, disulfiram should not be used unless the patient's goal is complete abstinence, a goal not necessary when treating with naltrexone or acamprosate. Finally, the literature is not clear that combining disulfiram with either naltrexone or acamprosate improves patient outcomes. Therefore, at this time the consensus panel does not recommend using disulfiram in combination with either naltrexone or acamprosate.

Choosing a Psychosocial Intervention

Any pharmacologic treatment for alcohol dependence should be used as an adjunct to, not a replacement for, psychosocial treatment. The literature suggests that the medication-psychosocial therapy combination is more effective than either alone. For example, Anton and colleagues (2005, 2006) reported the benefits of combining naltrexone and behavioral interventions for alcohol dependence, including longer time to relapse and increased time between relapse episodes.

Psychosocial treatments are likely to enhance compliance with pharmacotherapy; likewise, pharmacotherapies, to the extent that they reduce craving and help maintain abstinence, may make the patient more open to psychosocial interventions.

Types of Psychosocial Therapies

As with pharmacotherapy, there is no psychosocial “magic bullet.” However, a number of modalities of psychosocial therapy have been studied and validated for treatment of alcohol use disorders (reviewed by McCaul & Petry, 2003). Medical management (MM) is often practiced by primary care physicians in patients with diabetes and hypertension treatment. NIAAA developed an MM treatment as part of its COMBINE study (NIAAA, 2004). MM was designed specifically to accompany pharmacotherapy for AUDs and be delivered by medically trained clinicians in a medical setting. MM provides the structure and materials to enable clinicians to do the following:

  • Provide patients with strategies for taking their medications and staying in treatment
  • Provide educational materials about alcohol dependence and pharmacotherapy
  • Support patients' efforts to change drinking habits
  • Make direct recommendations for changing drinking behaviors.

An MM manual is available through NIAAA at http://www.niaaa.nih.gov.

Providers in psychiatric practice may provide psychosocial therapies on site. In the context of the primary care setting, however, delivering particular psychosocial therapies (e.g., group therapy) may be difficult because of time constraints, patient population, and lack of training. Brief interventions, motivational enhancement therapy, and MM treatment are more conducive to primary care settings (Anton et al., 2005, 2006). Sources of information about these interventions are listed in Exhibit 6-6. If these types of in-office interventions are not effective with a patient, or if the provider does not have the resources to offer them, providers may need to refer the patient for more intensive or specialized services.

Exhibit 6-6 Resources for Office-Based Psychosocial Approaches

TIP 34, Brief Interventions and Brief Therapies for Substance Abuse (CSAT, 1999a)

KAP Keys for Clinicians Based on TIP 34 (CSAT, 2001a)

Quick Guide for Clinicians Based on TIP 34 (CSAT, 2001c)

TIP 35, Enhancing Motivation for Change in Substance Abuse Treatment(CSAT, 1999b)

KAP Keys for Clinicians Based on TIP 35 (CSAT, 2001b)

Quick Guide for Clinicians Based on TIP 35 (CSAT, 2001d)

Helping Patients Who Drink Too Much: A Clinician's Guide(NIAAA, 2006)

NIAAA's A Pocket Guide for Alcohol Screening and Brief Intervention (see Appendix B)

Medical Management Treatment Manual: A Clinical Research Guide for Medically Trained Clinicians Providing Pharmacotherapy as Part of the Treatment for Alcohol Dependence (NIAAA, 2004)

Referring Patients for Specialty Treatment

Primary care practitioners may need to refer patients for psychosocial therapies, including to specialty substance abuse treatment programs. Many specialty substance abuse treatment programs provide comprehensive treatment services, either directly or through referrals, that address multiple factors affecting recovery. Such programs address not only immediate withdrawal and craving but management of long-term abstinence through the following:

  • Pharmacotherapy
  • Case monitoring
  • Individual, group, and family/couples counseling and therapy
  • Other psychosocial services (e.g., vocational counseling)
  • Referral to mutual-help groups.

The underlying basis for a specialty program is that optimal outcomes are achieved through a range of complementary services and that, as abstinence lengthens, other issues related to alcohol use become clearer and more amenable to treatment.

A practitioner who is planning to treat patients with alcohol dependence should become familiar with a range of local treatment resources. Developing relationships with treatment staff will facilitate smooth referrals and followup. In addition, understanding something about a program's treatment duration, modality, philosophy, and continuing-care options helps the practitioner better match a patient to appropriate treatment; practitioners can prepare the patient for what to expect, enhancing compliance with the referral. Practitioners can find programs in their areas or throughout the United States by using the interactive Substance Abuse Treatment Facility Locator on the Substance Abuse and Mental Health Services Administration (SAMHSA) Web site at http://dasis3.samhsa.gov.

Mutual- or Self-Help Programs

Mutual- or self-help group support can be critical to long-term recovery. The oldest, best-known, and most accessible mutual-help program is Alcoholics Anonymous (AA) (http://www.aa.org). Patients may resist attending AA meetings and may fear that disclosure of medication use may be unwelcome. Although some AA members may have negative attitudes toward medications, the organization itself supports appropriate medication use (AA, 1984). Providers should encourage patients to try different group meetings if they meet with negativity. Lists of local meetings can be obtained from http://www.aa.org and given to patients. Dual Recovery Anonymous (http://www.draonline.org) is a 12-Step program for patients with co-occurring psychiatric disorders. Other mutual- or self-help groups include Self Management and Recovery Training (http://www.smartrecovery.org) and Women for Sobriety, Inc. (http://www.womenforsobriety.org). Although groups other than AA are not available in every community, they do offer a number of online resources. For patients' family members, there are Al-Anon and Alateen meetings (http://www.al-anon.alateen.org).

Providers should have a working knowledge of the most common groups so that they can suggest these groups to their patients and discuss patients' participation.

Developing a Treatment Plan

Setting Goals: Abstinence or Reduction?

Each patient-provider interaction should assess and clarify outcome goals for the patient. A patient initially may seek to reduce alcohol consumption. Another patient may be motivated for total abstinence. Investigations into prescribing of pharmacotherapy employ both alcohol use reduction outcomes and abstinence outcomes to assess the efficacy of medications to treat alcohol dependence. Clinical outcomes to assess progress include the length of time to first drink, time to heavy drinking, cumulative abstinence days, and drinks per drinking episode. Each provider and patient should set an initial goal and be willing to refine that goal as treatment progresses.

If a patient with an AUD is unwilling to be completely abstinent, he or she may be willing to cut down on alcohol use. Practitioners can work with this while noting that abstinence is the safer strategy and has a greater chance of long-term success.

Certain conditions warrant advising a patient to abstain from rather than reduce drinking. As noted in the NIAAA (2006) clinician's guide, these conditions include when drinkers:

  • Are or may become pregnant
  • Are taking a contraindicated medication
  • Have a medical or psychiatric disorder caused or exacerbated by drinking
  • Have an AUD.

For those who drink heavily and who do not have an AUD, the practitioner should use professional judgment to determine whether cutting down or abstaining is more appropriate, based on factors such as (NIAAA, 2006):

  • A family history of alcohol problems
  • Advanced age
  • Injuries related to drinking.

Elements of a Treatment Plan

A comprehensive pharmacotherapy treatment plan for a patient with an AUD should include the following:

  • The medication to be used and a rationale for its use
  • Initial and maintenance dosages
  • A schedule for followup office visits and laboratory testing for monitoring health status and progress
  • Criteria for discontinuing the medication
  • A referral and followup plan for concurrent specialty substance abuse treatment, psychiatric treatment, and/or family therapy
  • A plan for mutual- or self-help group attendance
  • Clarification of family or significant other involvement in treatment
  • A plan for treating alcohol-related or other concurrent conditions.

Special attention must be paid to developing a medication compliance plan with the patient. This plan may include the following:

  • Specific strategies for remembering to take medications
  • Using blistercard packs or pill boxes
  • Monitoring medication compliance on an appropriate schedule given the patient's history of compliance with maintenance and other medication regimens
  • Involving the patient's family members in monitoring compliance.

Patient Awareness

Patient awareness is critical to successful pharmacotherapy. When starting any new medication, the patient should understand how the medication works and what to expect while taking it. Particularly when prescribing maintenance medications, treatment providers need to offer that information and guidance to patients. Patients also need to understand that alcohol dependence is a chronic medical disorder. They need to know that they may experience protracted effects from their alcohol use, including postacute withdrawal symptoms (e.g., sleep difficulties). When patients do not feel good, it is a challenge to keep them in treatment. Providers should educate patients to manage their concerns and anxieties. Exhibit 6-7 contains elements of effective patient education, and Exhibit 6-8 is a brief list of information resources providers can give patients.

Exhibit 6-7 Elements of Patient Education

Information about alcohol dependence as a chronic medical disorder

Description of what to expect in recovery, including symptoms of postacute withdrawal

List of the possible benefits of a particular medication

      Information about the medication itself:

      How and when to take it and the importance of complying with the regimen

      When the medication will become fully effective

      Possible common side effects and their expected duration

      Under what conditions the patient should immediately call the provider

      Any cautions regarding daily activities

      Medication interactions

Explanation of the importance for women of childbearing age to use an effective birth control method

Information about what to do if the patient starts drinking after a period of abstinence

Description of the importance of concurrent psychosocial treatment and mutual- or self-help programs

Followup plans

Specific patient education unique to each medication is in the medication chapters.

Exhibit 6-8 Information Resources for Patients

Al-Anon/Alateen

http://www.al-anon.alateen.org

1 (888) 425-2666

General information about how to find local meetings

Alcoholics Anonymous

http://www.aa.org

(212) 870-3400 (U.S. General Service Office)

General information, publications, and how to find local meetings

Dual Recovery Anonymous

http://www.draonline.org

General information, publications, and how to find local meetings

National Council on Alcoholism and Drug Dependence

http://www.ncadd.org

(212) 269-7797

Publications about AUDs and information about advocacy

NIAAA

http://www.niaaa.nih.gov

Information about AUDs, information for families, and publications

SMART Recovery

http://www.smartrecovery.org

1 (866) 951-5357

Information about recovery, online recovery tools, online meetings/chat groups/message boards, how to find face-to-face meetings, and publications

SAMHSA

http://www.samhsa.gov

1 (800) 662-HELP (Substance Abuse Treatment Facility Locator)

1 (800) 273-TALK (8255); 1 (800) 799-4889 (TTY) (National Suicide Prevention Lifeline)

Information about substance abuse and self-tests

FDA

http://www.fda.gov

1 (888) INFO-FDA

Patient information about medications to treat AUDs

Women for Sobriety, Inc.

http://www.womenforsobriety.org

(215) 536-8026

Online recovery tools, online chat groups, how to find face-to-face meetings, and publications

Monitoring Patient Progress

As it is with any chronic illness, monitoring of AUDs and pharmacologic treatment is important. Providers should monitor patients' ongoing treatment compliance, abstinence or reduced drinking, levels of craving, health status, social functioning, and use of other substances so that necessary adjustments in treatment plans can be made.

Monitoring Adherence

Several means exist for a provider to monitor patients' compliance with treatment plans, including the following:

  • Tracking patients' record of keeping (or not keeping) appointments for medication monitoring
  • Monitoring prescription refills
  • Noting whether patients are keeping agreements about payment for treatment
  • Requesting periodic status reports from specialty substance abuse treatment programs, psychiatric referrals, and other psychosocial therapy or support.

Monitoring Abstinence or Reduction in Alcohol Consumption

The ways in which providers can monitor patients' drinking behavior include the following:

  • Patient self-reports can be useful indicators of treatment success. The provider should discuss with the patient the quantity and frequency of drinking, especially during stressful periods (e.g., holidays, celebrations, major life changes).
  • Laboratory tests may include AST, GGT, CDT, EtG, and urine drug screening.

In addition, providers can use periodic BreathalyzerTM tests (although these detect only for a short period following ingestion) to monitor alcohol intake and provide positive feedback to patients who are successful in maintaining abstinence.

Monitoring Craving

Greatly diminished craving to drink alcohol is an optimum outcome of treatment. To assess craving, a physician can rely largely on the patient's subjective reports, although measures such as the Alcohol Urge Questionnaire (Bohn, Krahn, & Staehler, 1995) may prove useful.

More important than the method of monitoring is consistency in how the patient is asked about craving patterns and trends. Patients should be asked about current craving as well as how they felt over the past week (e.g., as a rating between 1 and 10, with 1 being no craving and 10 the most intense craving the patient has ever experienced). Patients may be asked whether any episodes have caused particular problems for them.

The patterns of craving over time can be useful. Both the provider and the patient can see that the patient's patterns of craving may fluctuate throughout the day and over longer periods; these patterns can assess the appropriateness to continue, adjust, supplement, enhance, or terminate pharmacologic treatment.

Providers should educate the patient about the role of craving in relapse. Learning from and responding optimistically to relapse may increase the patient's motivation to reduce or eliminate alcohol consumption.

Monitoring Health Status and Social Functioning

Ultimately, the goal of treatment is improved quality of life. It is important to monitor patients' progress over time in the following areas:

  • Health
    • Normalization of previously elevated blood pressure
    • Improvement of liver function
    • Stabilization of related medical problems that the patient was experiencing before treatment (e.g., control of blood glucose, stabilization of asthma, cardiomyopathy, encephalopathy, gastritis, ascites and edema)
    • Signs of increased concern about health care, such as seeing a physician for the first time in years and/or increased compliance with prescribed medication regimens not related to AUD treatment (e.g., asthma or blood pressure medications)
  • Family/social activities
    • Spending more positive time with children and/or spouse
    • Greater involvement/participation with family members
    • Improved intimate relationships
    • Reduced family conflict
    • Engagement in nondrinking leisure and recreational activities
  • Work/vocational status
    • Obtaining employment if previously unemployed
    • Improved attendance at work
    • Fewer job-related and financial problems
    • Improved job performance
  • Legal status
    • No parole or probation violations (in a patient with legal problems)
    • No new driving-under-the-influence charges
  • Mental status
    • Decreased irritability and anxiety
    • Improved mood
    • Improved sleep
    • Getting appropriate treatment for anxiety disorders, suicidal ideation, depression, or schizophrenia rather than self-medicating with alcohol.

Monitoring Other Substances of Abuse

It is important to address other substances of abuse that pose the same level of concern and possible adverse consequences. The abuse of other substances can be evaluated by random urinalysis collection and testing and self-reports from the patient. Use of illicit substances, tobacco use, and abuse of prescription and nonprescription medications should be addressed. The patient's agreement or resistance to continuing treatment may indicate his or her willingness to consider other substance use a problem.

Modifying the Treatment Strategy

An AUD is a chronic illness that, despite treatment, may wax and wane in intensity over time. Some patients may respond to psychosocial interventions, others to pharmacotherapy. Because a patient may respond to one medication and not to another, the provider should be flexible in modifying the medical regimen based on the patient's needs. Furthermore, a patient may choose to be treated for AUDs to reduce, eliminate, or discourage further escalation of consumption. A patient's goals may change over time, and providers should adapt to these new objectives.

As with patients who receive treatment for other chronic diseases, patients receiving treatment for AUDs may relapse. If this occurs, the provider should consider several options:

  • Increase monitoring of medication adherence
  • Increase the dose of the medication
  • Change the medication
  • Increase or change the intensity of psychosocial treatment to include referring the patient to specialty care
  • Examine social, medical, or behavioral factors that contribute to alcohol consumption.

Even after patients and providers have examined the reasons for relapse and have intensified or modified psychosocial treatment or pharmacotherapy, some patients may continue to resist reducing alcohol consumption. A small proportion of patients with AUDs may simply be resistant to treatment. For example, chronic relapsing patients are generally defined as patients who persistently consume alcohol despite regular and intensive social and medical interventions. These patients frequently use emergency services (Thornquist, Biros, Olander, & Sterner, 2002). They may resist or cannot effectively use pharmacological and psychosocial interventions because of poor social or environmental situations or other personal factors. These patients, often labeled as “difficult,” contribute to the perception of providers that treating AUDs is unlikely to be successful. Dealing with any chronic condition and changing harmful behavior are difficult. Understanding and accepting these difficulties can help providers keep patients moving forward, even if the pace is slow. Because treatment of chronic relapsing patients is difficult, it should be undertaken by addiction professionals in specialty treatment settings that use a multifaceted approach incorporating social, environmental, medical, behavioral, and motivational interventions.

Discontinuing Pharmacotherapy

Because an AUD is a chronic disorder, patients may need long-term use of medication or more than one episode of pharmacotherapy. In addition, some patients may benefit from using a medication over short periods to help them through a particularly stressful period or a situation that has typically elicited cravings for alcohol (e.g., a patient may want to take disulfiram or naltrexone while visiting family members who drink excessively).

Ideally, the patient and provider will decide together to discontinue pharmacotherapy. A patient may simply stop taking the medication. A patient also may express a desire to discontinue a medication because of side effects or for other reasons, or a patient will need to discontinue medication because of significant negative changes in laboratory findings or physical health status. Otherwise, the patient and provider may consider discontinuing medication under the following conditions:

  • The patient reports substantially diminished craving.
  • The patient has maintained stable abstinence over a sustained period.
  • The patient feels ready to discontinue the medication.
  • The patient is engaged in ongoing recovery, including community supports (such as attendance at mutual-help group meetings).

None of the medications discussed in this TIP are associated with a withdrawal syndrome, and they do not need to be tapered.

Final Clinical Thoughts

Management of the patient with an AUD may be seen as a series of stages:

  • Assessing the patient's suitability for treatment with a medication
  • Determining which medication should be used
  • Providing and/or referring the patient for psychosocial services
  • Assessing the patient's response to medication, including both efficacy (Is it working?) and side effects (Are there problems?).

This process is similar to becoming familiar with any new treatment regimen. AUDs may differ from other common chronic disorders mainly in that healthcare providers may perceive that they have few patients with AUDs. However, the pervasiveness of alcohol use and the substantial rates of AUDs in the United States make it extremely unlikely that the clinician is not seeing patients with AUDs. The provider simply may not recognize patients with problem alcohol use.

The availability of effective medications that can decrease rates of problem alcohol use or help patients maintain abstinence is an extremely important step forward in the treatment of AUDs. Physicians should become familiar with these medications, with the features of this patient population, and with the services that, combined with medication, can improve treatment outcome. AUDs are treatable medical conditions, and treatment can improve the patient's health and quality of life.

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