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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:


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

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
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