Trial Outcomes & Findings for Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use (NCT NCT00430573)
NCT ID: NCT00430573
Last Updated: 2018-05-17
Results Overview
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.
TERMINATED
PHASE2
15 participants
Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18)
2018-05-17
Participant Flow
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).
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.
Participant milestones
| Measure |
All Randomized Participants
The blind was never broken for the study drug, therefore, results can only be presented aggregated for all randomized participants.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
All Randomized Participants
The blind was never broken for the study drug, therefore, results can only be presented aggregated for all randomized participants.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use
Baseline characteristics by cohort
| Measure |
Overall Study Characteristics
n=10 Participants
All participants who consented to be in the study
|
|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18)Population: 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.
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.
Outcome measures
| Measure |
All Randomized Participants
n=10 Participants
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.
|
|---|---|
|
Percentage of Positive Toxicology Swabs for Illicit Substances
Baseline Period
|
80.0 percentage of positive toxicology swabs
Standard Deviation 35.0
|
|
Percentage of Positive Toxicology Swabs for Illicit Substances
Treatment Period (week12)
|
65.7 percentage of positive toxicology swabs
Standard Deviation 45.8
|
|
Percentage of Positive Toxicology Swabs for Illicit Substances
Follow-up Period (week 18)
|
59.6 percentage of positive toxicology swabs
Standard Deviation 44.1
|
SECONDARY outcome
Timeframe: Baseline, Mid Treatment (week 6), End of Treatment (week 12), Follow-up 1 (week 15), Follow-up 2 (week 18)Population: 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.
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.
Outcome measures
| Measure |
All Randomized Participants
n=8 Participants
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.
|
|---|---|
|
Addiction Severity Index (ASI) Drug Use Composite Score
Baseline
|
0.27 units on a scale
Standard Deviation 0.14
|
|
Addiction Severity Index (ASI) Drug Use Composite Score
Mid-Treatment (week 6)
|
0.19 units on a scale
Standard Deviation 0.12
|
|
Addiction Severity Index (ASI) Drug Use Composite Score
Endpoint of Treatment (week 12)
|
0.21 units on a scale
Standard Deviation 0.13
|
|
Addiction Severity Index (ASI) Drug Use Composite Score
Follow-Up 1 (week 15)
|
0.30 units on a scale
Standard Deviation 0.06
|
|
Addiction Severity Index (ASI) Drug Use Composite Score
Follow-Up 2 (week 18)
|
0.18 units on a scale
Standard Deviation 0.18
|
Adverse Events
All Randomized Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place