Linking Hospitalized Injection Drug Users to Buprenorphine - Full Text View

Sponsor:	Butler Hospital
Collaborator:	Boston Medical Center
Information provided by:	Butler Hospital
ClinicalTrials.gov Identifier:	NCT00987961

Purpose

This study tests whether starting Suboxone (buprenorphine) during a medical hospitalization, and then providing an appointment (a "link") for after discharge to maintenance buprenorphine in an outpatient setting will reduce HIV risk behavior in individuals who inject opioids.

Condition	Intervention	Phase
Opiate Dependence	Behavioral: Linkage	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Linking Hospitalized Injection Drug Users to Buprenorphine

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by Butler Hospital:

Primary Outcome Measures:

opioid use [ Time Frame: baseline, 1-month, 3-months, 6-months ] [ Designated as safety issue: No ]
HIV risk behavior [ Time Frame: baseline, 1-month, 3-months, 6-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

reduction in injection-related medical conditions [ Time Frame: baseline, 1-month, 3-months, 6-months ] [ Designated as safety issue: No ]
reduction in emergency department and hospital utilization [ Time Frame: baseline, 1-month, 3-months, 6-months ] [ Designated as safety issue: No ]

Estimated Enrollment:	195
Study Start Date:	September 2009
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment as usual: No Intervention Participants in this arm will receive the standard detox treatment for individuals hospitalized with opioid dependence.
Linkage: Experimental Participants in this arm will receive a maintenance schedule of Suboxone during their hospital stay, and an appointment with an outpatient Suboxone provider for after their discharge.	Behavioral: Linkage This intervention provides an outpatient appointment with a Suboxone provider for medically hospitalized opioid-dependent patients to attend post-discharge.

Detailed Description:

In this randomized controlled trial, medically hospitalized opioid dependent patients will be assigned to a "treatment as usual" group, where they will receive a detox regiment of Suboxone during their hospital stay, or a "linkage" group, where they receive a maintenance course of Suboxone during their hospital stay, and appointment post-discharge with an outpatient Suboxone clinic/provider and a Suboxone prescription to use between discharge and this appointment. Study interviews are completed at baseline, and 1, 3- and 6-months post-baseline. Primary outcomes are opioid use and HIV risk behavior.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age or older
Current opioid injector, at least weekly in the past month
Current opioid dependence, SCID confirmed
Currently receiving an inpatient buprenorphine detoxification protocol.

Exclusion Criteria:

Patients unable to be interviewed due to acute illness or cognitive impairment
In police custody, expecting incarceration
Persons who cannot provide two contact persons (including shelters, parole officers, etc.) to verify location
Not able to complete assessments in English
Enrolled in a methadone maintenance program
Plans to leave the area within the next 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987961

Contacts

Contact: Michael D Stein, MD	401-455-6646	michael_stein@brown.edu
Contact: Debra S Herman, PhD	401-455-6652	dherman@butler.org

Locations

United States, Massachusetts
Boston Medical Center	Recruiting
Boston, Massachusetts, United States, 02118
Contact: Michael D Stein, MD 401-455-6646 michael_stein@brown.edu
Contact: Debra S Herman, PhD 401-455-6652 dherman@butler.org
Principal Investigator: Jane Leibschutz, MD

Sponsors and Collaborators

Butler Hospital

Boston Medical Center

Investigators

Principal Investigator:

Michael D Stein, MD

Butler Hospital

More Information

No publications provided

Responsible Party:	Butler Hospital ( Michael Stein, M.D. )
Study ID Numbers:	1 R01 DA 026223
Study First Received:	September 30, 2009
Last Updated:	September 30, 2009
ClinicalTrials.gov Identifier:	NCT00987961 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Butler Hospital:

opioid dependence
suboxone
HIV risk behavior

Additional relevant MeSH terms:

Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Buprenorphine

Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010