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Drug Alcohol Depend. 2018 Jun 1;187:171-178. doi: 10.1016/j.drugalcdep.2018.02.023. Epub 2018 Apr 10.

Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: A phase 3 randomized trial.

Author information

1
Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, 1051 Riverside Dr., Unit #120, New York, NY, 10032, USA. Electronic address: Adam.Bisaga@nyspi.columbia.edu.
2
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 2213 Elba Street, Suite 156, DUMC 3074, Durham, NC, 27705, USA.
3
Alkermes, Inc., 852 Winter Street, Waltham, MA, 02451, USA.
4
Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences, 5510 Nathan Shock Drive, Baltimore, MD, 21224, USA.
5
Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.
6
Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, 1051 Riverside Dr., Unit #120, New York, NY, 10032, USA; Alkermes, Inc., 852 Winter Street, Waltham, MA, 02451, USA.

Abstract

BACKGROUND:

Injectable extended-release naltrexone (XR-NTX), approved to prevent relapse to opioid dependence, requires initial abstinence. This multisite outpatient clinical trial examined the efficacy and safety of low-dose oral naltrexone (NTX), combined with a brief buprenorphine (BUP) taper and standing ancillary medications, for detoxification and induction onto XR-NTX.

METHODS:

Patients (N = 378) were randomized, stratified by primary short-acting opioid-of-use, to one of three regimens: NTX + BUP; NTX + placebo BUP (PBO-B); placebo NTX (PBO-N) + PBO-B. Patients received 7 days of ascending NTX or placebo, concurrent with a 3-day BUP or placebo taper, and ancillary medications in an outpatient setting. Daily psychoeducational counseling was provided. On Day 8, patients passing a naloxone challenge received XR-NTX.

RESULTS:

Rates of transition to XR-NTX were comparable across groups: NTX/BUP (46.0%) vs. NTX/PBO-B (40.5%) vs. PBO-N/PBO-B (46.0%). Thus, the study did not meet its primary endpoint. Adverse events, reported by 32.5% of all patients, were mild to moderate in severity and consistent with opioid withdrawal. A first, second, and third XR-NTX injection was received by 44.4%, 29.9%, and 22.5% of patients, respectively. Compared with the PBO-N/PBO-B group, the NTX/BUP group demonstrated higher opioid abstinence during the transition and lower post-XR-NTX subjective opioid withdrawal scores.

CONCLUSIONS:

A 7-day detoxification protocol with NTX alone or NTX + BUP provided similar rates of induction to XR-NTX as placebo. For those inducted onto XR-NTX, management of opioid withdrawal symptoms prior to induction was achieved in a structured outpatient setting using a well-tolerated, fixed-dose ancillary medication regimen common to all three groups.

KEYWORDS:

Detoxification; Naltrexone; Opioid receptor antagonist; Opioid use disorder; Opioid withdrawal; Opioids

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