Phase 3
N=213
Buprenorphine for Prisoners
Heroin Addiction
Bottom Line
View on ClinicalTrials.gov: NCT00574067 ↗Enrolled (actual)
213
Serious AEs
18.0%
Results posted
Apr 2016
Primary outcome: Primary: Number of Days of Heroin Use — 6.0; 6.4; 6.5; 4.0 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Buprenorphine +OTP (Drug); Buprenorphine +CHC (Drug); Counseling +OTP (Drug); Counseling +CHC (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Friends Research Institute, Inc.
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days of Heroin Use |
6.0; 6.4; 6.5; 4.0 | — |
| PRIMARY Drug Abuse Treatment Entry and Retention in the Community |
22; 26; 23; 11 | — |
| SECONDARY Number of Days of Cocaine Use |
1.1; 4.1; 4.7; 2.7 | — |
| SECONDARY Criminal Activity |
3.4; 5.4; 3.3; 3.2 | — |
| SECONDARY Employment Status |
30.0; 29.6; 22.3; 31.4 | — |
| SECONDARY HIV Risk Behavior Needle Sharing |
2.9; .1; 2.1; .1 | — |
| SECONDARY HIV Risk Behavior |
59.7; 36.1; 33.3; 50.4 | — |
Summary
This five-year study examines the effectiveness of buprenorphine treatment provided to previously-addicted inmates(N=320; 160 males, 160 females) initiated in prison and continued in the community. The study also examines the extent to which the setting of post-release buprenorphine is provided.It is expected that participants receiving in-prison buprenorphine will have superior outcomes compared to participants who did not receive in-prison buprenorphine.
Eligibility Criteria
Inclusion Criteria
- pre-release prison inmate with 3-6 months remaining until planned release
- history of heroin dependence(meeting DSM-IV criteria of heroin dependence at the time of incarceration and manifesting physical dependence during the year preceding incarceration
- suitability for buprenorphine treatment as determined by medical evaluation
- willingness to participate in the study
- having a Baltimore address and planning to live in Baltimore after release from prison -
Exclusion Criteria
- evidence of kidney failure
- evidence of liver failure
- history of psychosis
- having a pending parole hearing
- unadjudicated charges that could result in additional prison time or transfer to another facility -
Data sourced from ClinicalTrials.gov (NCT00574067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.