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Combining Behavioral Treatment With Agonist Maintenance - 1

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.
ClinicalTrials.gov Identifier: NCT00000311
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
Yale University

Brief Summary:
The purpose of this study is to evaluate whether the community reinforcement approach (CRA) plus contingency management (CM) is more effective overall than CRA only in reducing illicit opioid and cocaine use during agonist maintenance treatment and at 3 and 6 month follow-up after completion of study protocol, and to compare the efficacy of maintenance on buprenorphine to methadone when maintenance is combined with CRA only or CRA plus CM.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Opioid-Related Disorders Substance-Related Disorders Drug: Buprenorphine Drug: methadone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Combining Behavioral Treatment With Agonist Maintenance
Study Start Date : February 1995
Primary Completion Date : February 1999
Study Completion Date : February 1999

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Methadone + CM (contingency management)
Drug: methadone
medication and behavioral
Experimental: 2
methadone + VC (voucher control)
Drug: methadone
medication and behavioral
Experimental: 3
Buprenorphine + CM
Drug: Buprenorphine
Medication and Behavioral
Experimental: 4
Buprenorphine + VC
Drug: Buprenorphine
Medication and Behavioral



Primary Outcome Measures :
  1. Depression [ Time Frame: 24 weeks ]
  2. Withdrawal symptoms
  3. Opioid and cocaine use
  4. Social and psychological functioning
  5. AIDS risk behavior


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Please contact site for information.

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): NCT00000311


Locations
United States, Connecticut
APT Residential Services Division
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Richard Schottenfeld, M.D. Yale University

Responsible Party: Richard S. Schottenfeld, MD, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00000311     History of Changes
Other Study ID Numbers: NIDA-09413-1
R01DA009413 ( U.S. NIH Grant/Contract )
R01-09413-1
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:
Cocaine-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders

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