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Buprenorphine Maintenance Dose Schedule and Treatment Setting - 1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000318
First Posted: September 21, 1999
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Yale University
Information provided by:
National Institute on Drug Abuse (NIDA)
  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
Intervention Model: Factorial Assignment
Masking: None (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 ]
  • Social and psychological functioning [ Time Frame: 26 weeks ]
  • AIDS risk behavior [ Time Frame: 26 weeks ]

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

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
Please contact site for information.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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 Submitted: September 20, 1999
First Posted: September 21, 1999
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