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Cognitive Enhancement and Relapse Prevention in Cocaine Addiction

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01067846
First received: February 10, 2010
Last updated: October 31, 2013
Last verified: October 2013
Results First Received: June 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cocaine Addiction
Interventions: Drug: Seromycin (D-cycloserine, DCS)
Drug: Placebo
Behavioral: Computerized Cognitive Behavioral Therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    DCS and Cognitive Behavioral Therapy   Placebo and Cognitive Behavioral Therapy
STARTED   29 [1]   30 [1] 
Completed 3 Tx Sessions   15 [2]   15 [2] 
COMPLETED   10 [3]   11 [3] 
NOT COMPLETED   19   19 
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
These numbers include participants that were eligible after the initial intake assessment and were assigned to a group.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   DCS and Cognitive Behavioral Therapy   Placebo and Cognitive Behavioral Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   30   59 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   29   30   59 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 44  (6.67)   45  (9.13)   44  (7.97) 
Gender 
[Units: Participants]
     
Female   7   4   11 
Male   22   26   48 
Region of Enrollment 
[Units: Participants]
     
United States   29   30   59 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Drug Abstinence During Treatment and at Follow up Visits   [ 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 ]

2.  Primary:   Treatment Retention – Number of Visits During Treatment   [ Time Frame: Treatment sessions included 3 visits per week for 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: CDKilts@uams.edu



Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01067846     History of Changes
Other Study ID Numbers: 111989
R21DA025243 ( US NIH Grant/Contract Award Number )
Study First Received: February 10, 2010
Results First Received: June 11, 2013
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board