Trial Outcomes & Findings for Cognitive Enhancement and Relapse Prevention in Cocaine Addiction (NCT NCT01067846)
NCT ID: NCT01067846
Last Updated: 2013-11-26
Results Overview
Percentage of the overall number of drug abstinences of participants measured by urine drug testing
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
Participants provided urine samples for drug testing during treatment which occurred 3 times per week for 4 weeks, at the end of treatment, and at a 1 and 2 month follow up visit
Results posted on
2013-11-26
Participant Flow
Recruitment included outpatient and inpatient alcohol and drug abuse clinics, self-referrals, flyers in public places, and advertisements in newspapers. Recruitment started June 2010 and ended September 2011.
Enrolled participants could have been excluded due to other drug dependencies, loss of consciousness \> 10 min, neurologic disorder, severe hepatic insufficiency, significant cardiovascular disease, current psychiatric disorder, current medical illness, sensory impairment, positive pregnancy test.
Participant milestones
| Measure |
DCS and Cognitive Behavioral Therapy
Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.
Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
|
Placebo and Cognitive Behavioral Therapy
Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.
Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
Completed 3 Tx Sessions
|
15
|
15
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
19
|
19
|
Reasons for withdrawal
| Measure |
DCS and Cognitive Behavioral Therapy
Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.
Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
|
Placebo and Cognitive Behavioral Therapy
Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.
Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
17
|
19
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
participation in other tx study
|
1
|
0
|
Baseline Characteristics
Cognitive Enhancement and Relapse Prevention in Cocaine Addiction
Baseline characteristics by cohort
| Measure |
DCS and Cognitive Behavioral Therapy
n=29 Participants
Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.
Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
|
Placebo and Cognitive Behavioral Therapy
n=30 Participants
Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.
Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
44 years
STANDARD_DEVIATION 6.67 • n=5 Participants
|
45 years
STANDARD_DEVIATION 9.13 • n=7 Participants
|
44 years
STANDARD_DEVIATION 7.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants provided urine samples for drug testing during treatment which occurred 3 times per week for 4 weeks, at the end of treatment, and at a 1 and 2 month follow up visitPopulation: Total possible urine samples = 225 per arm. Not all participants stayed in treatment, therefore the total units analyzed will not match the total possible.
Percentage of the overall number of drug abstinences of participants measured by urine drug testing
Outcome measures
| Measure |
DCS and Cognitive Behavioral Therapy
n=181 Urine Samples
Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.
Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
|
Placebo and Cognitive Behavioral Therapy
n=188 Urine Samples
Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.
Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
|
|---|---|---|
|
Drug Abstinence During Treatment and at Follow up Visits
|
12 percentage of drug abstinences
|
25 percentage of drug abstinences
|
PRIMARY outcome
Timeframe: Treatment sessions included 3 visits per week for 4 weeksPopulation: Total possible sessions attended = 180 per arm. Some participants did not complete all sessions, therefore the units analyzed will not match the total possible.
Number of treatment visits attended prior to discontinuation of treatment
Outcome measures
| Measure |
DCS and Cognitive Behavioral Therapy
n=149 Sessions Attended
Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.
Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
|
Placebo and Cognitive Behavioral Therapy
n=150 Sessions Attended
Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.
Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
|
|---|---|---|
|
Treatment Retention - Number of Visits During Treatment
|
10 visits
Standard Deviation 3
|
10 visits
Standard Deviation 3
|
Adverse Events
DCS and Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo and Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DCS and Cognitive Behavioral Therapy
n=29 participants at risk
Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.
Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
|
Placebo and Cognitive Behavioral Therapy
n=30 participants at risk
Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.
Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
cough
|
3.4%
1/29 • Number of events 1 • 1 year, 7 months
|
0.00%
0/30 • 1 year, 7 months
|
|
Nervous system disorders
headache
|
3.4%
1/29 • Number of events 1 • 1 year, 7 months
|
0.00%
0/30 • 1 year, 7 months
|
|
General disorders
nausea
|
3.4%
1/29 • Number of events 1 • 1 year, 7 months
|
0.00%
0/30 • 1 year, 7 months
|
|
Skin and subcutaneous tissue disorders
sensation on skin
|
0.00%
0/29 • 1 year, 7 months
|
3.3%
1/30 • Number of events 2 • 1 year, 7 months
|
|
Skin and subcutaneous tissue disorders
rash on skin
|
0.00%
0/29 • 1 year, 7 months
|
3.3%
1/30 • Number of events 2 • 1 year, 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place