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D-Cycloserine and Cue Exposure in Cocaine-Dependent Individuals

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ClinicalTrials.gov Identifier: NCT00780442
Recruitment Status : Completed
First Posted : October 27, 2008
Results First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Condition: Cocaine Use Disorders
Interventions: Drug: D-cycloserine
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
D-cycloserine Participants received DCS prior to cocaine cue exposure sessions.
Placebo Participants received placebo prior to cocaine cue exposure sessions.

Participant Flow:   Overall Study
    D-cycloserine   Placebo
STARTED   12   15 
COMPLETED   12   15 
NOT COMPLETED   0   0 



  Baseline Characteristics

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.
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Reporting Groups
  Description
D-cycloserine Participants received DCS prior to cocaine cue exposure sessions.
Placebo Participants received placebo prior to cocaine cue exposure sessions.
Total Total of all reporting groups

Baseline Measures
   D-cycloserine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   15   27 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      12 100.0%      15 100.0%      27 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  33.3%      5  33.3%      9  33.3% 
Male      8  66.7%      10  66.7%      18  66.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   6.7%      1   3.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      9  75.0%      10  66.7%      19  70.4% 
White      3  25.0%      4  26.7%      7  25.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Cocaine Craving Scale   [ Time Frame: Immediately following cue exposure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Kimber L. Price
Organization: Medical University of South Carolina
phone: 843-792-4847
e-mail: pricekl@musc.edu



Responsible Party: Aimee McRae-Clark, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00780442     History of Changes
Other Study ID Numbers: HR#16454
First Submitted: October 23, 2008
First Posted: October 27, 2008
Results First Submitted: May 3, 2018
Results First Posted: July 6, 2018
Last Update Posted: July 6, 2018