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Trial record 26 of 46 for:    disulfiram

CBT With Disulfiram and Contingency Management

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ClinicalTrials.gov Identifier: NCT00350870
Recruitment Status : Completed
First Posted : July 11, 2006
Results First Posted : December 3, 2014
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cocaine Abuse
Interventions Drug: disulfiram
Drug: Placebo
Behavioral: Placebo plus Contingency Management
Drug: Disulfiram plus Contingency Management
Enrollment 181
Recruitment Details  
Pre-assignment Details 181 patients were assessed for eligibility. 40 were found to be ineligible, and 42 did not complete the screening. 99 were randomized, but only 80 started (defined as having at least 1 day of study medication).
Arm/Group Title Placebo Disulfiram Placebo Plus Contingency Management Disulfiram Plus Contingency Management
Hide Arm/Group Description

Placebo (plus Cognitive Behavioral Therapy- CBT)

Placebo: Placebo plus CBT

Disulfiram (plus CBT)

disulfiram: 250mg per day of Disulfiram plus CBT

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 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.

Period Title: Overall Study
Started 27 28 22 22
Had at Least 1 Day of Med 19 24 18 19
Completed 5 11 6 7
Not Completed 22 17 16 15
Reason Not Completed
Withdrawal by Subject             21             17             15             14
Physician Decision             1             0             1             1
Arm/Group Title Placebo Disulfiram Placebo Plus Contingency Management Disulfiram Plus Contingency Management Total
Hide Arm/Group Description

Placebo (plus Cognitive Behavioral Therapy- CBT)

Placebo: Placebo plus CBT

Disulfiram (plus CBT)

disulfiram: 250mg per day of Disulfiram plus CBT

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 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.

Total of all reporting groups
Overall Number of Baseline Participants 27 28 22 22 99
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 28 participants 22 participants 22 participants 99 participants
39.6  (8.8) 39.8  (7.5) 38.5  (7.4) 39.3  (6.3) 39.3  (7.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 22 participants 22 participants 99 participants
Female
4
  14.8%
9
  32.1%
7
  31.8%
7
  31.8%
27
  27.3%
Male
23
  85.2%
19
  67.9%
15
  68.2%
15
  68.2%
72
  72.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 22 participants 22 participants 99 participants
Cuacasian 12 11 3 13 39
African-American 12 14 15 8 49
Latino 2 3 2 0 7
Multiracial/Other 1 0 2 1 4
1.Primary Outcome
Title Change in Cocaine Use by Self Report
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Disulfiram Placebo Plus Contingency Management Disulfiram Plus Contingency Management
Hide Arm/Group Description:

Placebo (plus Cognitive Behavioral Therapy- CBT)

Placebo: Placebo plus CBT

Disulfiram (plus CBT)

disulfiram: 250mg per day of Disulfiram plus CBT

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 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.

Overall Number of Participants Analyzed 27 28 22 22
Mean (Standard Deviation)
Unit of Measure: percentage of days abstinent
72.2  (27.3) 79.2  (18.1) 91.1  (13.6) 69.6  (31.7)
2.Primary Outcome
Title Change in Cocaine Use by Urine Toxicology Results
Hide Description We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Disulfiram Placebo Plus Contingency Management Disulfiram Plus Contingency Management
Hide Arm/Group Description:

Placebo (plus Cognitive Behavioral Therapy- CBT)

Placebo: Placebo plus CBT

Disulfiram (plus CBT)

disulfiram: 250mg per day of Disulfiram plus CBT

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 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.

Overall Number of Participants Analyzed 27 28 22 22
Mean (Standard Deviation)
Unit of Measure: percentage of negative urines
17.9  (32.3) 30.1  (39.6) 53  (41) 42.6  (43.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Disulfiram Placebo Plus Contingency Management Disulfiram Plus Contingency Management
Hide Arm/Group Description

Placebo (plus Cognitive Behavioral Therapy- CBT)

Placebo: Placebo plus CBT

Disulfiram (plus CBT)

disulfiram: 250mg per day of Disulfiram plus CBT

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 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.

All-Cause Mortality
Placebo Disulfiram Placebo Plus Contingency Management Disulfiram Plus Contingency Management
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Disulfiram Placebo Plus Contingency Management Disulfiram Plus Contingency Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/27 (37.04%)      10/28 (35.71%)      7/22 (31.82%)      7/22 (31.82%)    
General disorders         
Substance Use Hospitalization   6/27 (22.22%)  8 8/28 (28.57%)  9 4/22 (18.18%)  4 5/22 (22.73%)  7
Psychiatric disorders         
Psychiatric Hospitalization   2/27 (7.41%)  2 1/28 (3.57%)  1 2/22 (9.09%)  2 1/22 (4.55%)  1
Surgical and medical procedures         
Medical Hospitilization   2/27 (7.41%)  2 1/28 (3.57%)  1 2/22 (9.09%)  2 2/22 (9.09%)  3
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Disulfiram Placebo Plus Contingency Management Disulfiram Plus Contingency Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/27 (44.44%)      17/28 (60.71%)      10/22 (45.45%)      17/22 (77.27%)    
Eye disorders         
Optic Neuritis   0/27 (0.00%)  0 1/28 (3.57%)  1 0/22 (0.00%)  0 0/22 (0.00%)  0
Peripheral Neuritis   1/27 (3.70%)  1 1/28 (3.57%)  1 0/22 (0.00%)  0 1/22 (4.55%)  1
Gastrointestinal disorders         
Nausea and Vomiting   1/27 (3.70%)  1 5/28 (17.86%)  5 1/22 (4.55%)  1 4/22 (18.18%)  4
Diarrhea/Constipation   2/27 (7.41%)  2 4/28 (14.29%)  4 1/22 (4.55%)  1 5/22 (22.73%)  5
General disorders         
Drowsiness   2/27 (7.41%)  2 5/28 (17.86%)  5 2/22 (9.09%)  2 2/22 (9.09%)  2
Fatigue   1/27 (3.70%)  1 3/28 (10.71%)  3 2/22 (9.09%)  2 3/22 (13.64%)  3
Restlessness   2/27 (7.41%)  2 4/28 (14.29%)  4 1/22 (4.55%)  1 3/22 (13.64%)  3
Headache   4/27 (14.81%)  4 5/28 (17.86%)  5 1/22 (4.55%)  1 6/22 (27.27%)  6
Tremors   1/27 (3.70%)  1 1/28 (3.57%)  1 0/22 (0.00%)  0 0/22 (0.00%)  0
Aftertaste   1/27 (3.70%)  1 7/28 (25.00%)  7 2/22 (9.09%)  2 7/22 (31.82%)  7
Skin and subcutaneous tissue disorders         
Rash   0/27 (0.00%)  0 2/28 (7.14%)  2 0/22 (0.00%)  0 1/22 (4.55%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Kathleen M. Carroll
Organization: Yale University School Of Medicine Department of Psychiatry
Phone: 203-937-3486 ext 7403
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00350870     History of Changes
Other Study ID Numbers: 0408026992
5R01DA019078 ( U.S. NIH Grant/Contract )
First Submitted: July 7, 2006
First Posted: July 11, 2006
Results First Submitted: November 12, 2014
Results First Posted: December 3, 2014
Last Update Posted: December 3, 2014