Buprenorphine Maintenance Dose Schedule and Treatment Setting - 1

This study has been completed.

First Received: September 20, 1999 Last Updated: December 17, 2008 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	Yale University
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000318

Purpose

The purpose of this study is to assess optimal dosage of buprenorphine on a thrice weekly schedule in a pilot clinical trial.

Condition	Intervention	Phase
Opioid-Related Disorders Substance-Related Disorders	Drug: Buprenorphine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Factorial Assignment, Efficacy Study
Official Title:	Buprenorphine Maintenance Dose Schedule and Treatment Setting: Pilot

Resource links provided by NLM:

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:

Opioid and cocaine use [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Social and psychological functioning [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
AIDS risk behavior [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment:	202
Study Start Date:	December 1994
Study Completion Date:	August 2007
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Maintenance treatment with daily medication	Drug: Buprenorphine Experimental Maintenance treatment with daily medication Experimental Maintenance treatment with thrice-weekly medication
2: Experimental Maintenance treatment with thrice-weekly medication	Drug: Buprenorphine Experimental Maintenance treatment with daily medication Experimental Maintenance treatment with thrice-weekly medication

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Please contact site for information.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000318

Locations

United States, Connecticut
APT Residential Services Division
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Yale University

Investigators

Principal Investigator:

Richard Schottenfeld, M.D.

Yale University

More Information

No publications provided

Responsible Party:	Yale University School of Medicine ( Richard S. Schottenfeld, MD )
Study ID Numbers:	NIDA-09803-1, R01-09803-1
Study First Received:	September 20, 1999
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00000318 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

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

Pathologic Processes
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 November 09, 2009