Disulfiram and Cognitive Behavioral Therapy - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00350870

Purpose

This is a study of four treatments for chronic cocaine use and may help study participants to control their drug use. All participants will receive weekly individual cognitive behavioral therapy.

Condition	Intervention	Phase
Cocaine Abuse	Drug: disulfiram Behavioral: Placebo Behavioral: Placebo plus CM Drug: Disulfiram plus CM	Phase I

Drug Information available for: Disulfiram 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Factorial Assignment, Efficacy Study
Official Title:	Maximizing the Efficacy of Cognitive Behavioral Therapy With Medication and Contingency Management

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Reduction in cocaine use by self report and urine toxicology results [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Neurocognitive functioning [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	April 2005
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo plus CBT	Behavioral: Placebo Placebo plus CBT
2: Active Comparator Disulfiram plus CBT	Drug: disulfiram 250mg per day of Disulfiram plus CBT
3: Placebo Comparator Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT.	Behavioral: Placebo plus CM Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT
4: Active Comparator Disulfiram plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT.	Drug: Disulfiram plus CM 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.

Detailed Description:

This study will compare four types of treatment involving skills training and incentives for attending sessions or taking study medication. Disulfiram is a widely prescribed deterrent to alcohol use. In addition to weekly cognitive behavioral therapy, participants will be assigned to one of the following treatments:

placebo
disulfiram
placebo plus incentives for cocaine abstinence and medication compliance (prize CM)
disulfiram plus incentives for cocaine abstinence and medication compliance

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

18-50 year old
cocaine dependent
willing to sign consent
willing to accept randomization to intervention

Exclusion Criteria:

significant medical conditions
psychiatric disorder with current use of prescribed psychotropic medication
lifetime schizophrenia or bipolar disorder
suicidality or homicidality
unlikely to be able to complete 1 year follow up
unable to speak or read English at a third grade level

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350870

Contacts

Contact: Dorothy Eagan, RN, MPH	203-781-0282	deagan@aptfoundation.org
Contact: Liz Vollono, BS	203-781-0282	evollono@aptfoundation.org

Locations

United States, Connecticut
APT Foundation	Recruiting
New Haven, Connecticut, United States, 06510
Contact: Sam Ball, PhD 203-937-3486 samual.ball@yale.edu

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Kathleen M. Carroll, PhD

Yale School of Medicine

More Information

Responsible Party:	Yale University ( Kathleen Carroll, PhD )
Study ID Numbers:	0408026992, 5R01DA019078
Study First Received:	July 7, 2006
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00350870
Health Authority:	United States: Federal Government

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

disulfiram
cognitive behavioral therapy
contingency management
drug abuse therapy
educational/resource design/development

Study placed in the following topic categories:

Disulfiram
Cocaine-Related Disorders
Mental Disorders
Substance-Related Disorders

Disorders of Environmental Origin
Cocaine
Ethanol

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors

Central Nervous System Agents
Pharmacologic Actions
Alcohol Deterrents

ClinicalTrials.gov processed this record on January 14, 2009