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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA020583 | U.S. NIH Grant/Contract | View source | |
| 1R21DA020583 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Western Michigan University | OTHER |
| New York City Department of Health and Mental Hygiene | OTHER_GOV |
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The purpose of the study is to determine the feasibility of providing buprenorphine maintenance to opioid-dependent offenders in a jail setting and of transitioning those patients to buprenorphine maintenance in the community after their release.
Background: Heroin and other opioid abuse continues as a significant problem among the criminal justice population. In 2002, the criminal justice system was the source of referral for 36% of all substance abuse treatment admissions, the largest source of referrals. Heroin use among offenders has serious health and social consequences. Injection, still the primary route of administration among heroin users, is strongly associated with the transmission of HIV, hepatitis C and other blood-borne diseases. During 1997, 20% to 26% of all people living with HIV in the United States, and 29% to 43% of all those infected with hepatitis C, passed through a correctional facility. The relationship between heroin use and criminal activity has been extensively documented. Although methadone maintenance has been the primary treatment for chronic opioid dependence since the 1970's, correctional systems in the U.S., with very few exceptions (primarily Rikers Island in New York City), have not provided institutional access to methadone maintenance. Regrettably, negative attitudes to methadone are prevalent among criminal justice professionals, the public, treatment providers and opioid-dependent offenders themselves; there is little prospect of that changing soon. Buprenorphine maintenance is a recently approved therapy that may be more acceptable than methadone to the criminal justice system and opioid-dependent offenders. With one minor exception, buprenorphine has never been systematically administered as an opioid replacement therapy in a correctional setting in the U.S.
Aims and Objectives:
Study Design: Consenting eligible inmates at Rikers Island in New York City will be randomly assigned to buprenorphine or methadone maintenance in jail and will be referred to a corresponding community treatment upon their release. Subjects will be followed-up at 3 months after release from jail.
Target Population: Opioid-dependent jail inmates sentenced to 10- 90 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Buprenorphine maintenance |
|
| 2 | Active Comparator | Methadone maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| buprenorphine | Drug | maintenance |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment completion in jail | Until release from jail | |
| Reporting to assigned treatment modality after release | Within 3 months after release from jail |
| Measure | Description | Time Frame |
|---|---|---|
| Intention to continue treatment after release | At release from jail | |
| Re-incarceration | Within 3 months after release | |
| Frequency of illicit opioid use after release |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Magura, Ph.D. | Western Michigan University | Principal Investigator |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| D008691 | Methadone |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| methadone |
| Drug |
maintenance |
|
| Within 3 months after release |
| Re-arrest | Within 3 months after release |
| Severity of re-arrest charges | Within 3 months after release, if re-arrested |
| Satisfaction with opioid replacement treatment. | During jail and 3 months post-release |
| Opioid withdrawal symptoms and cravings | During jail and post-release |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009270 | Naloxone |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D007659 | Ketones |
| D009930 | Organic Chemicals |