Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release

NCT00367302 | Completed Phase 1

• 3 other identifiers: DA020583R21DA0205831R21DA020583
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Opiate Addiction

Keywords

addiction; jail; opiates; buprenorphine; clinical trial

Outcome Measures

Primary Outcomes (2)

• Treatment completion in jail

  Until release from jail

• Reporting to assigned treatment modality after release

  Within 3 months after release from jail

Secondary Outcomes (7)

• Intention to continue treatment after release

  At release from jail

• Re-incarceration

  Within 3 months after release

• Frequency of illicit opioid use after release

  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

Study Arms (2)

1

EXPERIMENTAL

Buprenorphine maintenance

Drug: buprenorphine

2

ACTIVE COMPARATOR

Methadone maintenance

Drug: methadone

Interventions

buprenorphine DRUG

maintenance

Also known as: Suboxone

1

methadone DRUG

maintenance

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• opioid dependent patients who meet eligibility requirements for the KEEP program,
• patients serving sentences who will remain confined for at least 10 days but less than 90 days in the EMTC facility (all male) at Rikers,
• willingness to accept buprenorphine treatment,
• expected to reside in New York City after release
• years of age

You may not qualify if:

• receiving methadone treatment in the community at sentencing and remanded to Rikers
• took non-prescribed 'street methadone' within last 3 days
• currently receiving more than 20mg/day methadone
• current psychotic symptoms (e.g., schizophrenia, schizoaffective disorder) requiring referral for mental health intervention, or current treatment with antipsychotic medication)
• HIV infection with T lymphocytes less than 200 per mm of blood and/or presence of a serious opportunistic infection requiring treatment, or receiving the HIV medication atazanavir.
• unable to complete English language interview

Sponsors & Collaborators

• National Development and Research Institutes, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Western Michigan University: collaborator
• New York City Department of Health and Mental Hygiene: collaborator

MeSH Terms

Conditions

Opioid-Related Disorders; Behavior, Addictive

Interventions

Buprenorphine; Buprenorphine, Naloxone Drug Combination; Methadone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone; Drug Combinations; Pharmaceutical Preparations; Ketones; Organic Chemicals

Study Officials

• Stephen Magura, Ph.D.

  Western Michigan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 21, 2006
• First Posted: August 22, 2006
• Study Start: August 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 1, 2013

Record last verified: 2013-04