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

Phase 2

Terminated

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
DCS-augmented CBT-IC	D-cycloserine	D-cycloserine-augmented CBT-IC
Placebo-augmented CBT-IC	Placebo	Placebo-augmented CBT-IC

Primary Outcome Measures

Name	Time	Method
Percentage of Positive Toxicology Swabs for Illicit Substances	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 Outcome Measures

Name	Time	Method
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)	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.