Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
181 participants
INTERVENTIONAL
2005-04-30
2010-12-31
Brief Summary
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Detailed Description
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1. placebo
2. disulfiram
3. placebo plus incentives for cocaine abstinence and medication compliance (prize CM)
4. disulfiram plus incentives for cocaine abstinence and medication compliance
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo (plus Cognitive Behavioral Therapy- CBT)
Placebo
Placebo plus CBT
Disulfiram
Disulfiram (plus CBT)
disulfiram
250mg per day of Disulfiram plus CBT
Placebo plus Contingency Management
Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Placebo plus Contingency Management
Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT
Disulfiram plus Contingency Management
Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Disulfiram plus Contingency Management
250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.
Interventions
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disulfiram
250mg per day of Disulfiram plus CBT
Placebo
Placebo plus CBT
Placebo plus Contingency Management
Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT
Disulfiram plus Contingency Management
250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* cocaine dependent
* willing to sign consent
* willing to accept randomization to intervention
Exclusion Criteria
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Kathleen M. Carroll, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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APT Foundation
New Haven, Connecticut, United States
Countries
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References
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Worhunsky PD, Stevens MC, Carroll KM, Rounsaville BJ, Calhoun VD, Pearlson GD, Potenza MN. Functional brain networks associated with cognitive control, cocaine dependence, and treatment outcome. Psychol Addict Behav. 2013 Jun;27(2):477-88. doi: 10.1037/a0029092. Epub 2012 Jul 9.
Carroll KM, Nich C, Shi JM, Eagan D, Ball SA. Efficacy of disulfiram and Twelve Step Facilitation in cocaine-dependent individuals maintained on methadone: a randomized placebo-controlled trial. Drug Alcohol Depend. 2012 Nov 1;126(1-2):224-31. doi: 10.1016/j.drugalcdep.2012.05.019. Epub 2012 Jun 12.
Other Identifiers
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0408026992
Identifier Type: -
Identifier Source: org_study_id