Trial Outcomes & Findings for CBT With Disulfiram and Contingency Management (NCT NCT00350870)
NCT ID: NCT00350870
Last Updated: 2014-12-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
181 participants
Primary outcome timeframe
12 weeks
Results posted on
2014-12-03
Participant Flow
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).
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
22
|
22
|
|
Overall Study
Had at Least 1 Day of Med
|
19
|
24
|
18
|
19
|
|
Overall Study
COMPLETED
|
5
|
11
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
22
|
17
|
16
|
15
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
21
|
17
|
15
|
14
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
1
|
Baseline Characteristics
CBT With Disulfiram and Contingency Management
Baseline characteristics by cohort
| Measure |
Placebo
n=27 Participants
Placebo (plus Cognitive Behavioral Therapy- CBT)
Placebo: Placebo plus CBT
|
Disulfiram
n=28 Participants
Disulfiram (plus CBT)
disulfiram: 250mg per day of Disulfiram plus CBT
|
Placebo Plus Contingency Management
n=22 Participants
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
n=22 Participants
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
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.6 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
39.8 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
38.5 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 6.3 • n=4 Participants
|
39.3 years
STANDARD_DEVIATION 7.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Cuacasian
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
3 participants
n=5 Participants
|
13 participants
n=4 Participants
|
39 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African-American
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
15 participants
n=5 Participants
|
8 participants
n=4 Participants
|
49 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Latino
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiracial/Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksSelf-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.
Outcome measures
| Measure |
Placebo
n=27 Participants
Placebo (plus Cognitive Behavioral Therapy- CBT)
Placebo: Placebo plus CBT
|
Disulfiram
n=28 Participants
Disulfiram (plus CBT)
disulfiram: 250mg per day of Disulfiram plus CBT
|
Placebo Plus Contingency Management
n=22 Participants
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
n=22 Participants
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.
|
|---|---|---|---|---|
|
Change in Cocaine Use by Self Report
|
72.2 percentage of days abstinent
Standard Deviation 27.3
|
79.2 percentage of days abstinent
Standard Deviation 18.1
|
91.1 percentage of days abstinent
Standard Deviation 13.6
|
69.6 percentage of days abstinent
Standard Deviation 31.7
|
PRIMARY outcome
Timeframe: 12 weeksWe will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids.
Outcome measures
| Measure |
Placebo
n=27 Participants
Placebo (plus Cognitive Behavioral Therapy- CBT)
Placebo: Placebo plus CBT
|
Disulfiram
n=28 Participants
Disulfiram (plus CBT)
disulfiram: 250mg per day of Disulfiram plus CBT
|
Placebo Plus Contingency Management
n=22 Participants
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
n=22 Participants
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.
|
|---|---|---|---|---|
|
Change in Cocaine Use by Urine Toxicology Results
|
17.9 percentage of negative urines
Standard Deviation 32.3
|
30.1 percentage of negative urines
Standard Deviation 39.6
|
53 percentage of negative urines
Standard Deviation 41
|
42.6 percentage of negative urines
Standard Deviation 43.7
|
Adverse Events
Placebo
Serious events: 10 serious events
Other events: 12 other events
Deaths: 0 deaths
Disulfiram
Serious events: 10 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo Plus Contingency Management
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
Disulfiram Plus Contingency Management
Serious events: 7 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=27 participants at risk
Placebo (plus Cognitive Behavioral Therapy- CBT)
Placebo: Placebo plus CBT
|
Disulfiram
n=28 participants at risk
Disulfiram (plus CBT)
disulfiram: 250mg per day of Disulfiram plus CBT
|
Placebo Plus Contingency Management
n=22 participants at risk
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
n=22 participants at risk
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.
|
|---|---|---|---|---|
|
Surgical and medical procedures
Medical Hospitilization
|
7.4%
2/27 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
9.1%
2/22 • Number of events 2
|
9.1%
2/22 • Number of events 3
|
|
General disorders
Substance Use Hospitalization
|
22.2%
6/27 • Number of events 8
|
28.6%
8/28 • Number of events 9
|
18.2%
4/22 • Number of events 4
|
22.7%
5/22 • Number of events 7
|
|
Psychiatric disorders
Psychiatric Hospitalization
|
7.4%
2/27 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
9.1%
2/22 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=27 participants at risk
Placebo (plus Cognitive Behavioral Therapy- CBT)
Placebo: Placebo plus CBT
|
Disulfiram
n=28 participants at risk
Disulfiram (plus CBT)
disulfiram: 250mg per day of Disulfiram plus CBT
|
Placebo Plus Contingency Management
n=22 participants at risk
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
n=22 participants at risk
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.
|
|---|---|---|---|---|
|
General disorders
Drowsiness
|
7.4%
2/27 • Number of events 2
|
17.9%
5/28 • Number of events 5
|
9.1%
2/22 • Number of events 2
|
9.1%
2/22 • Number of events 2
|
|
General disorders
Fatigue
|
3.7%
1/27 • Number of events 1
|
10.7%
3/28 • Number of events 3
|
9.1%
2/22 • Number of events 2
|
13.6%
3/22 • Number of events 3
|
|
General disorders
Restlessness
|
7.4%
2/27 • Number of events 2
|
14.3%
4/28 • Number of events 4
|
4.5%
1/22 • Number of events 1
|
13.6%
3/22 • Number of events 3
|
|
General disorders
Headache
|
14.8%
4/27 • Number of events 4
|
17.9%
5/28 • Number of events 5
|
4.5%
1/22 • Number of events 1
|
27.3%
6/22 • Number of events 6
|
|
General disorders
Tremors
|
3.7%
1/27 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
|
Eye disorders
Optic Neuritis
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
3.7%
1/27 • Number of events 1
|
17.9%
5/28 • Number of events 5
|
4.5%
1/22 • Number of events 1
|
18.2%
4/22 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea/Constipation
|
7.4%
2/27 • Number of events 2
|
14.3%
4/28 • Number of events 4
|
4.5%
1/22 • Number of events 1
|
22.7%
5/22 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/27
|
7.1%
2/28 • Number of events 2
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Aftertaste
|
3.7%
1/27 • Number of events 1
|
25.0%
7/28 • Number of events 7
|
9.1%
2/22 • Number of events 2
|
31.8%
7/22 • Number of events 7
|
|
Eye disorders
Peripheral Neuritis
|
3.7%
1/27 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
Additional Information
Dr. Kathleen M. Carroll
Yale University School Of Medicine Department of Psychiatry
Phone: 203-937-3486
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place