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Buprenorphine Maintenance Dose Schedule and Treatment Setting - 1

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ClinicalTrials.gov Identifier: NCT00000318
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Substance-Related Disorders Drug: Buprenorphine Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Buprenorphine Maintenance Dose Schedule and Treatment Setting: Pilot
Study Start Date : December 1994
Primary Completion Date : March 2004
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Opioid and cocaine use [ Time Frame: 26 weeks ]
  2. Social and psychological functioning [ Time Frame: 26 weeks ]
  3. AIDS risk behavior [ Time Frame: 26 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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Contacts and Locations

Information from the National Library of Medicine

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: December 2008

Keywords provided by National Institute on Drug Abuse (NIDA):
opioid dependence

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