CBT With Disulfiram and Contingency Management

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00350870
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 181
• Location: 1
• Arms: 4
• Duration (Months): 68
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cocaine Abuse	Drug: disulfiram; Drug: Placebo; Behavioral: Placebo plus Contingency Management; Drug: Disulfiram plus Contingency Management	Phase 1

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 (CBT), participants will be assigned to one of the following treatments:

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 181 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Maximizing the Efficacy of Cognitive Behavioral Therapy With Medication and Contingency Management
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo (plus Cognitive Behavioral Therapy- CBT)	Drug: Placebo; Placebo plus CBT
Active Comparator: Disulfiram Disulfiram (plus CBT)	Drug: disulfiram; 250mg per day of Disulfiram plus CBT; Other Names: antabuse antabus
Placebo Comparator: Placebo plus Contingency Management Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).	Behavioral: Placebo plus Contingency Management; Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT
Active Comparator: Disulfiram plus Contingency Management Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).	Drug: Disulfiram plus Contingency Management; 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.; Other Names: antabuse antabus

Outcome Measures

Primary Outcome Measures

1. Change in Cocaine Use by Self Report [12 weeks]

   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.

2. Change in Cocaine Use by Urine Toxicology Results [12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	APT Foundation	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

• Yale University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Kathleen M. Carroll, PhD, Yale School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00350870
• Other Study ID Numbers: 0408026992; 5R01DA019078
• First Posted: Jul 11, 2006
• Last Update Posted: Dec 3, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Yale University: disulfiram; cognitive behavioral therapy; contingency management; drug abuse therapy; educational/resource design/development
• Additional relevant MeSH terms: Cocaine-Related Disorders; Disulfiram

Study Results

Participant Flow

Pre-assignment Detail	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
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

Baseline Characteristics

Arm/Group Title	Placebo	Disulfiram	Placebo Plus Contingency Management	Disulfiram Plus Contingency Management	Total
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 Participants	27	28	22	22	99
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.6 (8.8)	39.8 (7.5)	38.5 (7.4)	39.3 (6.3)	39.3 (7.5)
Sex: Female, Male (Count of 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 (participants) [Number]
Cuacasian	12 44.4%	11 39.3%	3 13.6%	13 59.1%	39 39.4%
African-American	12 44.4%	14 50%	15 68.2%	8 36.4%	49 49.5%
Latino	2 7.4%	3 10.7%	2 9.1%	0 0%	7 7.1%
Multiracial/Other	1 3.7%	0 0%	2 9.1%	1 4.5%	4 4%

Outcome Measures

1. Primary Outcome

Title	Change in Cocaine Use by Self Report
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Disulfiram	Placebo Plus Contingency Management	Disulfiram Plus Contingency Management
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.
Measure Participants	27	28	22	22
Mean (Standard Deviation) [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
Description	We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Disulfiram	Placebo Plus Contingency Management	Disulfiram Plus Contingency Management
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.
Measure Participants	27	28	22	22
Mean (Standard Deviation) [percentage of negative urines]	17.9 (32.3)	30.1 (39.6)	53 (41)	42.6 (43.7)

Adverse Events

Arm/Group Title	Placebo		Disulfiram		Placebo Plus Contingency Management		Disulfiram Plus Contingency Management
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
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%)		10/28 (35.7%)		7/22 (31.8%)		7/22 (31.8%)
General disorders
Substance Use Hospitalization	6/27 (22.2%)	8	8/28 (28.6%)	9	4/22 (18.2%)	4	5/22 (22.7%)	7
Psychiatric disorders
Psychiatric Hospitalization	2/27 (7.4%)	2	1/28 (3.6%)	1	2/22 (9.1%)	2	1/22 (4.5%)	1
Surgical and medical procedures
Medical Hospitilization	2/27 (7.4%)	2	1/28 (3.6%)	1	2/22 (9.1%)	2	2/22 (9.1%)	3
Other (Not Including 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	12/27 (44.4%)		17/28 (60.7%)		10/22 (45.5%)		17/22 (77.3%)
Eye disorders
Optic Neuritis	0/27 (0%)	0	1/28 (3.6%)	1	0/22 (0%)	0	0/22 (0%)	0
Peripheral Neuritis	1/27 (3.7%)	1	1/28 (3.6%)	1	0/22 (0%)	0	1/22 (4.5%)	1
Gastrointestinal disorders
Nausea and Vomiting	1/27 (3.7%)	1	5/28 (17.9%)	5	1/22 (4.5%)	1	4/22 (18.2%)	4
Diarrhea/Constipation	2/27 (7.4%)	2	4/28 (14.3%)	4	1/22 (4.5%)	1	5/22 (22.7%)	5
General disorders
Drowsiness	2/27 (7.4%)	2	5/28 (17.9%)	5	2/22 (9.1%)	2	2/22 (9.1%)	2
Fatigue	1/27 (3.7%)	1	3/28 (10.7%)	3	2/22 (9.1%)	2	3/22 (13.6%)	3
Restlessness	2/27 (7.4%)	2	4/28 (14.3%)	4	1/22 (4.5%)	1	3/22 (13.6%)	3
Headache	4/27 (14.8%)	4	5/28 (17.9%)	5	1/22 (4.5%)	1	6/22 (27.3%)	6
Tremors	1/27 (3.7%)	1	1/28 (3.6%)	1	0/22 (0%)	0	0/22 (0%)	0
Aftertaste	1/27 (3.7%)	1	7/28 (25%)	7	2/22 (9.1%)	2	7/22 (31.8%)	7
Skin and subcutaneous tissue disorders
Rash	0/27 (0%)	0	2/28 (7.1%)	2	0/22 (0%)	0	1/22 (4.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.