Results of a pilot randomized controlled trial of buprenorphine for opioid dependent women in the criminal justice system

Abstract

Aims: Recent studies have demonstrated the efficacy of both methadone and buprenorphine when used with opioid dependent men transitioning from prison to the community, but no studies have been conducted with women in the criminal justice (CJ) system. The aim of this study was to determine the efficacy of buprenorphine for relapse prevention among opioid dependent women in the CJ system transitioning back to the community.

Methods: 36 women under CJ supervision were recruited from an inpatient drug treatment facility that treats CJ individuals returning back to the community. Nine were enrolled in an open label buprenorphine arm then 27 were randomized to buprenorphine (n=15) or placebo (n=12; double-blind). All women completed baseline measures and started study medication prior to release. Participants were followed weekly, provided urine drug screens (UDS), received study medication for 12 weeks, and returned for a 3-month follow-up. Intent-to-treat analyses were performed for all time points through 3 month follow-up.

Results: The majority of participants were Caucasian (88.9%), young (M±SD=31.8±8.4 years), divorced/separated (59.2%) women with at least a high school/GED education (M±SD=12±1.7 years). GEE analyses showed that buprenorphine was efficacious in maintaining abstinence across time compared to placebo. At end of treatment, 92% of placebo and 33% of active medication participants were positive for opiates on urine drug screen (Chi-Square=10.9, df=1; p<0.001). However, by the three month follow-up point, no differences were found between the two groups, with 83% of participants at follow-up positive for opiates.

Conclusions: Women in the CJ system who received buprenorphine prior to release from a treatment facility had fewer opiate positive UDS through the 12 weeks of treatment compared to women receiving placebo. Initiating buprenorphine in a controlled environment prior to release appears to be a viable strategy to reduce opiate use when transitioning back to the community.

Figure 1

Enrollment and Study Flow

Figure 2

Percentage of Positive Urine Drug Screens by Time and Treatment Condition (n=36) Note: WK = Week; Weeks 1–12 is treatment phase; 3MO= 3 month follow-up; all WK 1–6; 8–12 p’s <0.05; WK7 and 3MO p’s = ns. Chi-Square analyses were used to calculate p-values at each time point. GEE was used for the overall significance testing of the model.

Figure 3

Percentage of Positive Urine Drug Screens by Time and Treatment Condition (n=36) Note: WK = Week; Weeks 1–12 is treatment phase; 3MO= 3 month follow-up; WK3, 4, 7–12 all p’s <0.05; WK1–2, 5–6 and 3MO p’s = ns. Chi-Square analyses were used to calculate p-values at each time point. GEE was used for the overall significance testing of the model.