Buprenorphine Maintenance Dose Schedule and Treatment Setting - 1

This study has been completed.
Sponsor:
Collaborator:
Yale University
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00000318
First received: September 20, 1999
Last updated: December 17, 2008
Last verified: December 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Buprenorphine Maintenance Dose Schedule and Treatment Setting: Pilot

Resource links provided by NLM:


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
Experimental: 1
Maintenance treatment with daily medication
Drug: Buprenorphine
  1. Experimental Maintenance treatment with daily medication
  2. Experimental Maintenance treatment with thrice-weekly medication
Experimental: 2
Maintenance treatment with thrice-weekly medication
Drug: Buprenorphine
  1. Experimental Maintenance treatment with daily medication
  2. 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

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  Contacts and Locations
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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
Yale University
Investigators
Principal Investigator: Richard Schottenfeld, M.D. Yale University
  More Information

No publications provided

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

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on August 18, 2014