Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use
Overview
- Phase
- Phase 2
- Intervention
- D-cycloserine
- Conditions
- Substance-Related Disorders
- Sponsor
- Boston University Charles River Campus
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Percentage of Positive Toxicology Swabs for Illicit Substances
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
This study examines whether isolated doses of d-cycloserine enhance the efficacy of an exposure-based cognitive-behavioral treatment for chronic and treatment refractory substance dependence.
Detailed Description
This is a placebo-controlled trial of the efficacy of 50mg d-cycloserine or matching pill placebo for enhancing the efficacy of CBT.
Investigators
Michael Otto
Ph.D.
Boston University Charles River Campus
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Patients with significantly unstable or uncontrolled medical illness which may interfere with participation in treatment (e.g., patients likely to require hospitalization during the study period).
- •Patients with a psychotic or organic mental disorder according to DSM-IV criteria.
- •Patients receiving medication affecting methadone metabolism (e.g. rifampin).
- •Patients with uncontrolled bipolar disorder as evidenced by meeting current criteria for mania or hypomania or meeting criteria for rapid cycling in the last year (as indicated by structured questioning of all patients meeting criteria for bipolar disorder).
- •Patients unable to complete the informed consent or unable to understand study procedures in the informed consent process.
- •Pregnancy or current alcohol use.
Arms & Interventions
DCS-augmented CBT-IC
D-cycloserine-augmented CBT-IC
Intervention: D-cycloserine
Placebo-augmented CBT-IC
Placebo-augmented CBT-IC
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of Positive Toxicology Swabs for Illicit Substances
Time Frame: Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18)
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.
Secondary Outcomes
- Addiction Severity Index (ASI) Drug Use Composite Score(Baseline, Mid Treatment (week 6), End of Treatment (week 12), Follow-up 1 (week 15), Follow-up 2 (week 18))