TY - JOUR
KW - Administration, Intravenous
KW - Adult
KW - Analgesics, Opioid/therapeutic use
KW - Double-Blind Method
KW - Female
KW - Heroin/administration & dosage/therapeutic use
KW - Humans
KW - Hydromorphone/administration & dosage/therapeutic use
KW - Male
KW - Middle Aged
KW - Opioid-Related Disorders/drug therapy
KW - Patient reported outcome measures
KW - Sex Characteristics
KW - Substance Abuse, Intravenous/drug therapy
KW - Treatment Outcome
KW - Clinical Trial
KW - Gender
KW - Opioid-dependence
KW - patient perceptions
AU - H. Palis
AU - K. Marchand
AU - D. Guh
AU - S. Brissette
AU - K. Lock
AU - S. MacDonald
AU - S. Harrison
AU - A. H. Anis
AU - M. Krausz
AU - D. C. Marsh
AU - M. T. Schechter
AU - E. Oviedo-Joekes
A1 - 
AB - 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 .
AD - Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575- 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada.; School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada.; Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575- 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada.; School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada.; Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575- 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada.; Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM), Hopital Saint-Luc, Montreal, QC, H2X 3J4, Canada.; Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575- 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada.; Providence Crosstown Clinic, Providence Health Care, 84 West Hastings Street, Vancouver, BC, V6B 1G6, Canada.; Providence Crosstown Clinic, Providence Health Care, 84 West Hastings Street, Vancouver, BC, V6B 1G6, Canada.; Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575- 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada.; Department of Psychiatry, Faculty of Medicine, Detwiller Pavilion 2255 Wesbrook Mall, Vancouver, BC, V6T 2A1, Canada.; Northern Ontario School of Medicine, 935 Ramsey Lake Road, Sudbury, ON, P3E 2C6, Canada.; Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575- 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada.; School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada.; 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.;(TRUNCATED)
BT - Substance abuse treatment, prevention, and policy
C5 - Opioids & Substance Use
CP - 1
CY - England
DO - 10.1186/s13011-017-0110-9
IS - 1
JF - Substance abuse treatment, prevention, and policy
M1 - Journal Article
N2 - 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 .
PP - England
PY - 2017
SN - 1747-597X; 1747-597X
SP - 25
T1 - 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
T2 - Substance abuse treatment, prevention, and policy
TI - 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
U1 - Opioids & Substance Use
U2 - 28526048
U3 - 10.1186/s13011-017-0110-9
VL - 12
VO - 1747-597X; 1747-597X
Y1 - 2017
Y2 - May 19
ER -