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Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use

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ClinicalTrials.gov Identifier: NCT00430573
Recruitment Status : Terminated (The investigators failed to recruit participants as originally projected.)
First Posted : February 2, 2007
Results First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Massachusetts General Hospital
Information provided by (Responsible Party):
Michael Otto, Boston University Charles River Campus

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Substance-Related Disorders
Interventions Drug: D-cycloserine
Drug: Placebo
Enrollment 15
Recruitment Details This pilot study was terminated due to inadequate recruitment. The primary reason was unwillingness to take a study drug (a parent study that did not require randomized drug was likely a factor in this decision).
Pre-assignment Details 15 people consented to this study but 4 did not meet entry criteria and 1 was loss to follow-up before completing baseline evaluations. 10 participants were randomized and 5 dropped out before taking study drug.
Arm/Group Title All Randomized Participants
Hide Arm/Group Description The blind was never broken for the study drug, therefore, results can only be presented aggregated for all randomized participants.
Period Title: Overall Study
Started 10
Completed 5 [1]
Not Completed 5
Reason Not Completed
Withdrawal by Subject             5
[1]
Only 5 took study drug on at least one occasion and 8 completed the baseline ASI.
Arm/Group Title Overall Study Characteristics
Hide Arm/Group Description All participants who consented to be in the study
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
10 participants were randomized out of the initial15 who consented to the study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
40.7  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
6
  60.0%
Male
4
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
10
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  50.0%
White
5
  50.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Percentage of Positive Toxicology Swabs for Illicit Substances
Hide Description The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates.
Time Frame Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18)
Hide Outcome Measure Data
Hide Analysis Population Description
Toxicology swabs were obtained on all 10 randomized participants irrespective of taking study drug. At baseline all 10 had toxicology swabs, at treatment (week 12) 7 had toxicology swabs and at follow-up (week 18) 7 had toxicology swabs.
Arm/Group Title All Randomized Participants
Hide Arm/Group Description:
10 participants were randomized and 5 dropped out before taking study drug. The blind was never broken for the study drug, Therefore, results can only be presented aggregated for all randomized participants.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: percentage of positive toxicology swabs
Baseline Period Number Analyzed 10 participants
80.0  (35.0)
Treatment Period (week12) Number Analyzed 7 participants
65.7  (45.8)
Follow-up Period (week 18) Number Analyzed 7 participants
59.6  (44.1)
2.Secondary Outcome
Title Addiction Severity Index (ASI) Drug Use Composite Score
Hide Description For the drug use composite scores, each of 13 questions about drug use is divided by its maximum answer value and by the total number of questions in the composite. These individual items are then summed, so that possible total scores range from 0 to 1, with higher scores reflecting greater drug use problem severity.
Time Frame Baseline, Mid Treatment (week 6), End of Treatment (week 12), Follow-up 1 (week 15), Follow-up 2 (week 18)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants were asked to complete the ASI irrespective of taking study drug. At least one ASI was completed by 8 of the 10 randomized participants. At baseline 8 completed the ASI and the number of participants at each subsequent time point varied.
Arm/Group Title Randomized Participants That Completed Baseline ASI
Hide Arm/Group Description:
8 of the 10 randomized participants completed the baseline ASI evaluation.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 8 participants
0.27  (0.14)
Mid-Treatment (week 6) Number Analyzed 8 participants
0.19  (0.12)
Endpoint of Treatment (week 12) Number Analyzed 6 participants
0.21  (0.13)
Follow-Up 1 (week 15) Number Analyzed 4 participants
0.30  (0.06)
Follow-Up 2 (week 18) Number Analyzed 5 participants
0.18  (0.18)
Time Frame One year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Randomized Participants
Hide Arm/Group Description 10 participants were randomized and 5 dropped out before taking study drug. The blind was never broken for the study drug, Therefore, results can only be presented aggregated for all randomized participants.
All-Cause Mortality
All Randomized Participants
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
All Randomized Participants
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Randomized Participants
Affected / at Risk (%)
Total   0/10 (0.00%) 
Study was terminated due to low enrollment/adherence with the study drug. 10 participants were randomized, 5 dropped out before taking study drug. The blind was never broken so results can only be presented aggregated for all randomized participants.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Michael W. Otto, Ph.D.
Organization: BostonUCRC
Phone: (617)353-9610
EMail: mwotto@bu.edu
Responsible Party: Michael Otto, Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT00430573     History of Changes
Other Study ID Numbers: R01 DA017904-S1
R01DA017904 ( U.S. NIH Grant/Contract )
First Submitted: January 31, 2007
First Posted: February 2, 2007
Results First Submitted: February 7, 2018
Results First Posted: May 17, 2018
Last Update Posted: May 17, 2018