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Trial record 78 of 121 for:    CYCLOSERINE OR SEROMYCIN

Cognitive Enhancement and Relapse Prevention in Cocaine Addiction

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ClinicalTrials.gov Identifier: NCT01067846
Recruitment Status : Completed
First Posted : February 12, 2010
Results First Posted : November 26, 2013
Last Update Posted : November 26, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cocaine Addiction
Interventions Drug: Seromycin (D-cycloserine, DCS)
Drug: Placebo
Behavioral: Computerized Cognitive Behavioral Therapy
Enrollment 85
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title DCS and Cognitive Behavioral Therapy Placebo and Cognitive Behavioral Therapy
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 29 [1] 30 [1]
Completed 3 Tx Sessions 15 [2] 15 [2]
Completed 10 [3] 11 [3]
Not Completed 19 19
Reason Not Completed
Lost to Follow-up             17             19
Withdrawal by Subject             1             0
participation in other tx study             1             0
[1]
Due to exclusion prior to group assignment, Study Enrollment will not equal Total # of Participants.
[2]
Our final analysis includes these participants.
[3]
Participants that completed all 4 weeks of treatment.
Arm/Group Title DCS and Cognitive Behavioral Therapy Placebo and Cognitive Behavioral Therapy Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 29 30 59
Hide Baseline Analysis Population Description
These numbers include participants that were eligible after the initial intake assessment and were assigned to a group.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 30 participants 59 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
 100.0%
30
 100.0%
59
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 30 participants 59 participants
44  (6.67) 45  (9.13) 44  (7.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 30 participants 59 participants
Female
7
  24.1%
4
  13.3%
11
  18.6%
Male
22
  75.9%
26
  86.7%
48
  81.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 30 participants 59 participants
29 30 59
1.Primary Outcome
Title Drug Abstinence During Treatment and at Follow up Visits
Hide Description Percentage of the overall number of drug abstinences of participants measured by urine drug testing
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Total possible urine samples = 225 per arm. Not all participants stayed in treatment, therefore the total units analyzed will not match the total possible.
Arm/Group Title DCS and Cognitive Behavioral Therapy Placebo and Cognitive Behavioral Therapy
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 15 15
Overall Number of Units Analyzed
Type of Units Analyzed: Urine Samples
181 188
Measure Type: Number
Unit of Measure: percentage of drug abstinences
12 25
2.Primary Outcome
Title Treatment Retention – Number of Visits During Treatment
Hide Description Number of treatment visits attended prior to discontinuation of treatment
Time Frame Treatment sessions included 3 visits per week for 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Total possible sessions attended = 180 per arm. Some participants did not complete all sessions, therefore the units analyzed will not match the total possible.
Arm/Group Title DCS and Cognitive Behavioral Therapy Placebo and Cognitive Behavioral Therapy
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 15 15
Overall Number of Units Analyzed
Type of Units Analyzed: Sessions Attended
149 150
Mean (Standard Deviation)
Unit of Measure: visits
10  (3) 10  (3)
Time Frame 1 year, 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DCS and Cognitive Behavioral Therapy Placebo and Cognitive Behavioral Therapy
Hide Arm/Group Description

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.

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.

All-Cause Mortality
DCS and Cognitive Behavioral Therapy Placebo and Cognitive Behavioral Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DCS and Cognitive Behavioral Therapy Placebo and Cognitive Behavioral Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DCS and Cognitive Behavioral Therapy Placebo and Cognitive Behavioral Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/29 (10.34%)      2/30 (6.67%)    
General disorders     
nausea * [1]  1/29 (3.45%)  1 0/30 (0.00%)  0
Nervous system disorders     
headache * [2]  1/29 (3.45%)  1 0/30 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
cough * [3]  1/29 (3.45%)  1 0/30 (0.00%)  0
Skin and subcutaneous tissue disorders     
sensation on skin * [4]  0/29 (0.00%)  0 1/30 (3.33%)  2
rash on skin * [5]  0/29 (0.00%)  0 1/30 (3.33%)  2
*
Indicates events were collected by non-systematic assessment
[1]
Participant reported a nauseas feeling. Physician determined it was not study related.
[2]
Participant reported mild headaches. Physician determined it was not study related.
[3]
Participant reported infrequent coughing. Physician determined it was not study related.
[4]
Participant reported a crawling sensation on skin. Physician determined it was not study related.
[5]
Participant reported a rash on skin. Physician determined it was not study related.
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
Name/Title: Clint Kilts, PhD
Organization: Brain Imaging Research Center
Phone: 526-8163
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01067846     History of Changes
Other Study ID Numbers: 111989
R21DA025243 ( U.S. NIH Grant/Contract )
First Submitted: February 10, 2010
First Posted: February 12, 2010
Results First Submitted: June 11, 2013
Results First Posted: November 26, 2013
Last Update Posted: November 26, 2013