Prison Buprenorphine - Full Text View

Sponsor:	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
Heroin Addiction	Drug: Buprenorphine	Phase III

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:

MedlinePlus related topics: Heroin

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

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 ]

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
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

Contacts

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

Locations

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

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

More Information

No publications provided

Responsible Party:	Timothy W. Kinlock, Ph.D., Friends Research Institute
ClinicalTrials.gov Identifier:	NCT00574067 History of Changes
Other Study ID Numbers:	52-070-1445, 1RO1DA021579-01A1
Study First Received:	December 12, 2007
Last Updated:	September 29, 2008
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 February 13, 2012