NCT00350870

Brief Summary

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 (CBT).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2006

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4 years until next milestone

Results Posted

Study results publicly available

December 3, 2014

Completed
Last Updated

December 3, 2014

Status Verified

November 1, 2014

Enrollment Period

5.7 years

First QC Date

July 7, 2006

Results QC Date

November 12, 2014

Last Update Submit

November 26, 2014

Conditions

Cocaine Abuse

Keywords

disulfiramcognitive behavioral therapycontingency managementdrug abuse therapyeducational/resource design/development

Outcome Measures

Primary Outcomes (2)

  • Change in Cocaine Use by Self Report

    Self-reports of substance use will be documented at each contact via the Substance Use Calendar. Similar to the Form-90 and the Time Line Follow-Back, which have been shown to be reliable and valid instruments for monitoring substance use and other outcomes in longitudinal studies202-204, the Substance Use Calendar allows a flexible, continuous evaluation of substance use on a daily basis.

    12 weeks

  • Change in Cocaine Use by Urine Toxicology Results

    We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids.

    12 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo (plus Cognitive Behavioral Therapy- CBT)

Drug: Placebo

Disulfiram

ACTIVE COMPARATOR

Disulfiram (plus CBT)

Drug: disulfiram

Placebo plus Contingency Management

PLACEBO COMPARATOR

Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).

Behavioral: Placebo plus Contingency Management

Disulfiram plus Contingency Management

ACTIVE COMPARATOR

Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).

Drug: Disulfiram plus Contingency Management

Interventions

disulfiramDRUG

250mg per day of Disulfiram plus CBT

Also known as: antabuse, antabus
Disulfiram
PlaceboDRUG

Placebo plus CBT

Placebo
Placebo plus Contingency ManagementBEHAVIORAL

Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT

Placebo plus Contingency Management
Disulfiram plus Contingency ManagementDRUG

250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.

Also known as: antabuse, antabus
Disulfiram plus Contingency Management

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • year old
  • cocaine dependent
  • willing to sign consent
  • willing to accept randomization to intervention

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APT Foundation

New Haven, Connecticut, 06510, United States

Location

Related Publications (2)

  • 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.

    PMID: 22775772DERIVED

  • 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.

    PMID: 22695473DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Disulfiram

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DitiocarbThiocarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsDisulfidesSulfidesSulfur Compounds

Results Point of Contact

Title
Dr. Kathleen M. Carroll
Organization
Yale University School Of Medicine Department of Psychiatry
kathleen.carroll@yale.edu
203-937-3486

Study Officials

  • Kathleen M. Carroll, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2006

First Posted

July 11, 2006

Study Start

April 1, 2005

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 3, 2014

Results First Posted

December 3, 2014

Record last verified: 2014-11

Locations

US(1)