Changes in quality of life in cocaine-dependent participants provided treatment with buprenorphine+naloxone combined with extended release naltrexone.

Qualify of life is an important construct in assessing outcomes of substance use treatment interventions. The goal of the current analysis was to evaluate changes in participants’ quality of life in the Clinical Trials Network multi-site Cocaine Use Reduction with Buprenorphine (CURB) study in cocaine-dependent opioid users. Participants were randomly assigned to 1 of 3 conditions provided with extended-release naltrexone: 16 mg/day buprenorphine+naloxone (BUP) (BUP 16), 4mg/day BUP (BUP 4), 0mg/day BUP (placebo, PLB), plus weekly therapy and extended-release naltrexone (XR-NTX). Participants completed the WHOQOL-BREF at screening, end of medication/treatment, and the 3-month follow-up. This 24-item measure assessed quality of life across physical, psychological, social, and environmental domains. Of the 302 study participants, 219 completed QOL surveys at all time points and were used in the analyses. Baseline Quality of Life scores were lower than the norms established for individuals in a healthy population in all domains. No treatment effects were found, but there were statistically significant differences in mean ratings of QOL across the time points in all domains: physical, psychological, social, and environmental. Despite the significant increase in QOL at end of treatment, compared to the general population, participants were still scoring low in Social and Environmental domains.

Conclusions: The results showed significant improvements in quality of life between the start and end of treatment. However, despite the improvement, participants remained considerably lower than healthy population norms across some domains, suggesting the particular vulnerability of this substance-using population.

Related protocols: CTN-0048