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Trial record 80 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

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
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description Participants received DCS prior to cocaine cue exposure sessions. Participants received placebo prior to cocaine cue exposure sessions.
Period Title: Overall Study
Started 12 15
Completed 12 15
Not Completed 0 0
Arm/Group Title D-cycloserine Placebo Total
Hide Arm/Group Description Participants received DCS prior to cocaine cue exposure sessions. Participants received placebo prior to cocaine cue exposure sessions. Total of all reporting groups
Overall Number of Baseline Participants 12 15 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 15 participants 27 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 15 participants 27 participants
Female
4
  33.3%
5
  33.3%
9
  33.3%
Male
8
  66.7%
10
  66.7%
18
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 15 participants 27 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%
1.Primary Outcome
Title Cocaine Craving Scale
Hide Description Scale assess cocaine craving following cocaine cue exposure after two administrations of DCS. Subjects rate craving on a scale from 0-10 with 0 indicating "Not at all" and 10 indicating "Extremely".
Time Frame Immediately following cue exposure
Hide Outcome Measure Data
Hide Analysis Population Description
Cocaine dependent individuals
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
Participants received DCS prior to cocaine cue exposure sessions.
Participants received placebo prior to cocaine cue exposure sessions.
Overall Number of Participants Analyzed 12 15
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.33  (3.98) 3.13  (2.92)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description Participants received DCS prior to cocaine cue exposure sessions. Participants received placebo prior to cocaine cue exposure sessions.
All-Cause Mortality
D-cycloserine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
D-cycloserine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
D-cycloserine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/15 (0.00%) 
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
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