Prison Buprenorphine
This study has been completed.
Sponsor:
Friends Research Institute, Inc.
Collaborator:
Information provided by (Responsible Party):
Friends Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT00574067
First received: December 12, 2007
Last updated: April 12, 2013
Last verified: April 2013
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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 |
|---|---|---|
|
Heroin Addiction |
Drug: Buprenorphine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Buprenorphine for Prisoners |
Resource links provided by NLM:
Further study details as provided by Friends Research Institute, Inc.:
Primary Outcome Measures:
- Heroin use [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Drug abuse treatment entry and retention in the community [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Cocaine use [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- HIV infection [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- HIV risk behaviors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Criminal activity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Employment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 213 |
| Study Start Date: | September 2008 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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
Other Name: Suboxone
|
| Experimental: 2 |
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.
Other Name: Suboxone
|
| Active Comparator: 3 |
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.
Other Name: Suboxone
|
| Active Comparator: 4 |
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.
Other Name: Suboxone
|
Detailed Description:
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 |
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 -
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00574067
Locations
| United States, Maryland | |
| Metropolitan Transition Center | |
| Baltimore, Maryland, United States, 21201 | |
| Maryland Correctional Institution for Women | |
| Jessup, Maryland, United States, 20794 | |
Sponsors and Collaborators
Friends Research Institute, Inc.
More Information
No publications provided
| Responsible Party: | Friends Research Institute, Inc. |
| ClinicalTrials.gov Identifier: | NCT00574067 History of Changes |
| Other Study ID Numbers: | 1RO1DA021579-01A1, R01DA021579, 1RO1DA021579-01A1 |
| Study First Received: | December 12, 2007 |
| Last Updated: | April 12, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Heroin Dependence Behavior, Addictive Opioid-Related Disorders Substance-Related Disorders Mental Disorders Compulsive Behavior Impulsive Behavior Buprenorphine Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on June 18, 2013