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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00574067 |
Purpose
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.
| Condition | Intervention | Phase |
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Heroin Addiction |
Drug: Buprenorphine |
Phase III |
| MedlinePlus related topics: | Heroin |
| Drug Information available for: | Buprenorphine Buprenorphine hydrochloride |
| Study Type: | Interventional |
| Study Design: | Health Services Research, Randomized, Open Label, Parallel Assignment |
| Official Title: | Buprenorphine for Prisoners |
| Estimated Enrollment: | 320 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Drug: Buprenorphine
Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
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| 2: Experimental |
Drug: Buprenorphine
Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
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| 3: Active Comparator |
Drug: Buprenorphine
Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
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| 4: Active Comparator |
Drug: Buprenorphine
Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
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Participants will be randomly assigned, within gender, to one of four treatment conditions: 1) buprenorphine and counseling in prison, with referral for continued treatment at an OTP upon release; 2) buprenorphine and counseling in prison, with referral for continued treatment at a CHC upon release; 3) counseling only in prison, with referral for buprenorphine and counseling at a OTP upon release; and 4) counseling only in prison, with referral for buprenorphine and counseling at a CHC upon release. Participants will be assessed at study entry and at 1, 3, 6, and 12 months following their release from prison. Outcome measures include: treatment entry and retention in the community, heroin use, cocaine use, HIV infection, HIV-risk behaviors, criminal activity, and employment.
Eligibility
| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Timothy W Kinlock, Ph.D. | (410) 837-3977 ext 224 | tkinlock@frisrc.org |
| Contact: Michael S Gordon | (410) 837-3977 ext 251 | mgordon@frisrc.org |
| United States, Maryland | |||||
| Metropolitan Transition Center | Recruiting | ||||
| Baltimore, Maryland, United States, 21201 | |||||
| Contact: Andrew Stritch 410-837-1502 astritch@dpscs.md.us | |||||
| Baltimore Pre-Release Unit for Women | Not yet recruiting | ||||
| Baltimore, Maryland, United States, 21223 | |||||
| Contact: Bianca Elliott 410-223-2260 belliott@dpscs.state.md.us | |||||
More Information
| Responsible Party: | Friends Research Institute ( Timothy W. Kinlock, Ph.D. ) |
| Study ID Numbers: | 52-070-1445, 1RO1DA021579-01A1 |
| First Received: | December 12, 2007 |
| Last Updated: | September 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00574067 |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board |
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