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Subst Abuse Treat Prev Policy. 2017 May 19;12(1):25. doi: 10.1186/s13011-017-0110-9.

Men's and women's response to treatment and perceptions of outcomes in a randomized controlled trial of injectable opioid assisted treatment for severe opioid use disorder.

Author information

1
Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575- 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada.
2
School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada.
3
Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Hôpital Saint-Luc, Montréal, QC, H2X 3J4, Canada.
4
Providence Crosstown Clinic, Providence Health Care, 84 West Hastings Street, Vancouver, BC, V6B 1G6, Canada.
5
Department of Psychiatry, Faculty of Medicine, Detwiller Pavilion 2255 Wesbrook Mall, Vancouver, BC, V6T 2A1, Canada.
6
Northern Ontario School of Medicine, 935 Ramsey Lake Road, Sudbury, ON, P3E 2C6, Canada.
7
Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575- 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada. eugenia@cheos.ubc.ca.
8
School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada. eugenia@cheos.ubc.ca.

Abstract

BACKGROUND:

To test whether there are gender differences in treatment outcomes among patients receiving injectable opioids for the treatment of long-term opioid-dependence. The study additionally explores whether men and women have different perceptions of treatment effectiveness.

METHODS:

This study is a secondary analysis from SALOME, a double-blind, phase III, randomized controlled trial testing the non-inferiorirty of injectable hydromorphone to injectable diacetylmorphine among 202 long-term street opioid injectors in Vancouver (Canada). Given this was a secondary analysis, no a priori power calaculation was conducted. Differences in baseline characteristics and six-month treatment outcomes (illicit heroin use, opioid use, crack cocaine use, non-legal activities, physical and psychological health scores, urine positive for street heroin markers, and retention) were analysed by gender using fitted models. Responses to an open ended question on reasons for treatment effectiveness were explored with a thematic analysis.

RESULTS:

Men and women differed significantly on a number of characteristics at baseline. For example, women were significantly younger, presented to treatment with significantly higher rates of prior month sex work (31.5% vs. 0%), and used significantly more crack cocaine (14.71 vs. 8.38 days). After six-months of treatment there were no significant differences in treatment outcomes by gender, after adjusting for baseline values. For both men and women, improved health and quality of life were the most common reasons provided for treatment effectiveness, however women were more specific in the types of health improvements.

CONCLUSIONS:

Despite presenting to treatment with vulnerabilities not faced to the same extent by men, at six-months women did not differ significantly from men in tested trial efficacy outcomes. While the primary outcome in the trial was the reduction of illicit opioid use, in the open-ended responses both men and women focused their comments on improvement in health and quality of life as reasons for treatment effectiveness. The supervised model of care with injectable medications provides a particularly suitable framework for providing care to opioid-dependent men and women not attracted or retained by other treatments. The absence of statistical differences reported in this secondary analysis may be due to lack of adequate statistical power to detect meaningful effects.

TRIAL REGISTRATION:

This trial is registered with ClinicalTrials.gov (NCT01447212) Registered: October 4, 2011 at the following link: https://clinicaltrials.gov/ct2/show/NCT01447212 .

KEYWORDS:

Clinical trial; Gender; Opioid-dependence; Patient perceptions

PMID:
28526048
PMCID:
PMC5437624
DOI:
10.1186/s13011-017-0110-9
[Indexed for MEDLINE]
Free PMC Article

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