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Randomized Controlled Trial
. 2017 Mar 1:172:34-42.
doi: 10.1016/j.drugalcdep.2016.11.037. Epub 2017 Jan 11.

A randomized clinical trial of buprenorphine for prisoners: Findings at 12-months post-release

Michael S Gordon  1 , Timothy W Kinlock  2 , Robert P Schwartz  3 , Kevin E O'Grady  4 , Terrence T Fitzgerald  5 , Frank J Vocci  6
Affiliations
Randomized Controlled Trial

A randomized clinical trial of buprenorphine for prisoners: Findings at 12-months post-release

Michael S Gordon et al. Drug Alcohol Depend. .

Abstract

Background: This study examined whether starting buprenorphine treatment prior to prison and after release from prison would be associated with better drug treatment outcomes and whether males and females responded differently to the combination of in-prison treatment and post-release service setting.

Methods: Study design was a 2 (In-Prison Treatment: Condition: Buprenorphine Treatment: vs. Counseling Only)×2 [Post-Release Service Setting Condition: Opioid Treatment: Program (OTP) vs. Community Health Center (CHC)]×2 (Gender) factorial design. The trial was conducted between September 2008 and July 2012. Follow-up assessments were completed in 2014. Participants were recruited from two Baltimore pre-release prisons (one for men and one for women). Adult pre-release prisoners who were heroin-dependent during the year prior to incarceration were eligible. Post-release assessments were conducted at 1, 3, 6, and 12-month following prison release.

Results: Participants (N=211) in the in-prison treatment condition effect had a higher mean number of days of community buprenorphine treatment compared to the condition in which participants initiated medication after release (P=0.005). However, there were no statistically significant hypothesized effects for the in-prison treatment condition in terms of: days of heroin use and crime, and opioid and cocaine positive urine screening test results (all Ps>0.14) and no statistically significant hypothesized gender effects (all Ps>0.18).

Conclusions: Although initiating buprenorphine treatment in prison compared to after-release was associated with more days receiving buprenorphine treatment in the designated community treatment program during the 12-months post-release assessment, it was not associated with superior outcomes in terms of heroin and cocaine use and criminal behavior.

Keywords: Buprenorphine; Heroin addiction; Opioid substitution therapy; Prisoners.

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Conflict of interest statement

This study was supported by an unrestricted, unsolicited investigator initiated request from Reckitt Benckiser Pharmaceuticals, Inc. (provided study drug only) who had no role in study design; collection, analysis and interpretation of data; in the writing of the manuscript; or in the decision to submit the manuscript for publication. The authors alone are responsible for the content and writing of this manuscript. Drs. Gordon, Kinlock, and Fitzgerald received funding from Alkermes on a prior study. Dr. Schwartz did a one-time consultation for Reckitt-Benckiser on behalf of his employer (the Friends Research Institute). Dr. O’Grady has in the past received funding for his time from Reckitt-Benckiser. Dr. Vocci has consulted with and received other funding (meals, travel expenses) from the following companies: Braeburn Pharmaceuticals, Demerx, Indivior, Pinney Associates. He has received travel and meal expenses from Intratab Labs Inc., and received consulting fees from Alkermes and Usona Institute. All of Dr. Vocci’s consulting fees go to his employer, Friends Research Institute, Inc.

Figures

Figure 1
Figure 1. Consort Diagram
B+OTP: Buprenorphine in prison and continued at an Opioid Treatment Program (OTP) B+CHC: Buprenorphine in prison and continued an a Community Health Center (CHC) C+OTP: Counseling only in prison and initiation of buprenorphine at an OT C+CHC: Counseling only in prison and initiation of buprenorphine at a CHC
Figure 2
Figure 2. Self-reported heroin use in the past 30 days for Buprenorphine in Prison vs. Buprenorphine in the Community a,b,c
a Estimated Marginal Means (Standard Errors). b past 30 days at 1,3,6,12-month post release. Adjusted for days at risk in the community. c Self-reports 1-month: 204 participants were interviewed. 7 were not interviewed due to: received additional prison time (n=3), unable to locate (n=3), detainer in another state (n=1) 3-month: 204 participants were interviewed. 7 were not interviewed due to: received additional prison time (n=3), unable to locate (n=3), detainer in another state (n=1) 6-month: 176 participants were interviewed, 35 were not interviewed due to: received additional prison time (n=3), unable to locate (n=3), detainer in another state (n=1), Incarcerated/located at later follow-up (n=28) 12-month: 150 participants were interviewed. 61 individuals were not interviewed due to: received additional prison time (n=3), unable to locate (n=3), detainer in another state (n=1), incarcerated/located at later follow-up (n=54).
Figure 3
Figure 3. Estimated Marginal Means (Standard Errors) for opioid-positive urine screening test results by Buprenorphine in Prison vs. Buprenorphine in the Community
Urine testing proportion of positive and negative results for those tested at each follow-up time point:

  1. 1-month: Buprenorphine in prison (16/68, 23.5%) vs. Buprenorphine in the community (17/69, 24.6%); tested positive for other opioids only (n=5).

  2. 3-month: Buprenorphine in prison (21/73, 28.8%) vs. Buprenorphine in the community (25/74, 33.8%); tested positive for other opioids only (n=4).

  3. 6-month: Buprenorphine in prison (22/70, 31.4%) vs. Buprenorphine in the community (29/70, 41.4%); tested positive for other opioids only (n=5).

  4. 12-month: Buprenorphine in prison (18/61, 29.5%) vs. Buprenorphine in the community (21/63, 33.3%) tested positive for other opioids only (n=3).

Urine testing missing:

  1. 1-month: 137 samples analyzed, Results missing for 74 due to: missed interview window (n=55), incarcerated (n=10), unable to locate (n=3), refused (n=3), specimen leaked/lost (n=2), detainer in another state (n=1).

  2. 3-month 147 samples analyzed. Results missing for 64 due to: missed interview window (n=33), incarcerated (n=25), unable to locate (n=3), detainer in another state (n=1), phone interview (n=1), refused (n=1)

  3. 6-month: 140 samples analyzed. Results missing for 71 due to: incarcerated (n=42), missed interview window (n=17), phone interview (n=3), unable to locate (n=3), refused (n=2), no record (n=2), medical (n=1), detainer in another state (n=1)

  4. 12-month: 124 samples analyzed. Results missing for 87 due to: incarcerated (n=79), unable to locate (n=3), phone interview (n=2), medical (n=1), detainer in another state (n=1), no record (n=1).

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