We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Buprenorphine for Prisoners

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00574067
First Posted: December 14, 2007
Last Update Posted: April 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Friends Research Institute, Inc.
  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 +OTP Drug: Buprenorphine +CHC Drug: Counseling +OTP Drug: Counseling +CHC Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:
  • Number of Days of Heroin Use [ Time Frame: 1 year ]
    mean days used heroin during the past 30 days

  • Drug Abuse Treatment Entry and Retention in the Community [ Time Frame: 1 year ]
    entered community treatment within 10 days of release from prison (yes vs. no)


Secondary Outcome Measures:
  • Number of Days of Cocaine Use [ Time Frame: 1 year ]
    Number of days used cocaine during the past 30 days.

  • Criminal Activity [ Time Frame: 1 year ]
    Days of crime during the past 30 days

  • Employment Status [ Time Frame: 1 year ]
    Number of days employed during the past year

  • HIV Risk Behavior Needle Sharing [ Time Frame: 1 year ]
    Number of times shared a needle during the past year

  • HIV Risk Behavior [ Time Frame: 1 year ]
    Number of times had sex without using a condom during the past year


Enrollment: 213
Study Start Date: September 2008
Study Completion Date: November 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buprenorphine+OTP
Buprenorphine and counseling in prison and continued at opioid treatment program (OTP) upon release.
Drug: Buprenorphine +OTP
Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment (OTP) 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: Buprenorphine+CHC
Buprenorphine and counseling in prison and continued at a community health center (CHC) upon release.
Drug: Buprenorphine +CHC
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 (CHC). Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
Other Name: Suboxone
Active Comparator: Counseling + OTP
Counseling only in prison and Buprenorphine upon release at a opioid treatment program (OTP)
Drug: Counseling +OTP
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: Counseling + CHC
Counseling only in prisons and Buprenorphine upon release at a community health center (CHC)
Drug: Counseling +CHC
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. pre-release prison inmate with 3-6 months remaining until planned release
  2. 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
  3. suitability for buprenorphine treatment as determined by medical evaluation
  4. willingness to participate in the study
  5. having a Baltimore address and planning to live in Baltimore after release from prison -

Exclusion Criteria:

  1. evidence of kidney failure
  2. evidence of liver failure
  3. history of psychosis
  4. having a pending parole hearing
  5. unadjudicated charges that could result in additional prison time or transfer to another facility -
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.
National Institute on Drug Abuse (NIDA)
  More Information

Publications:
Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00574067     History of Changes
Other Study ID Numbers: 1R01DA021579-01A1 ( U.S. NIH Grant/Contract )
R01DA021579 ( U.S. NIH Grant/Contract )
First Submitted: December 12, 2007
First Posted: December 14, 2007
Results First Submitted: August 11, 2015
Results First Posted: April 11, 2016
Last Update Posted: April 11, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists