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

Study Overview
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Brief Summary
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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
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This is a placebo-controlled trial of the efficacy of 50mg d-cycloserine or matching pill placebo for enhancing the efficacy of CBT.

Official Title
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Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use

Conditions
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Substance-Related Disorders

Intervention / Treatment
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* Drug: D-cycloserine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: The primary selection criteria include women and men between the ages of 18 and 65 who: Meet DSM-IV criteria for opiate dependence, Maintain a stable dose of methadone for two weeks prior to recruitment and: fail to achieve take-home status for methadone dosing during at least the first four months of methadone treatment, test positive on at least two toxicology screens for illicit drugs during the month prior to recruitment have never achieved two consecutive toxicology screens free of illicit substances since entering the current treatment episode. Meet study criteria for chronic stress: unemployment criteria, and affective disorder criteria. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCS-augmented CBT-IC<br>D-cycloserine-augmented CBT-IC | Drug: D-cycloserine<br>* Single dosage of D-cycloserine is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)<br>* Other names: DCS;|
| Placebo Comparator: Placebo-augmented CBT-IC<br>Placebo-augmented CBT-IC | Drug: Placebo<br>* Single dosage of placebo is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Positive Toxicology Swabs for Illicit Substances | 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. | Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Addiction Severity Index (ASI) Drug Use Composite Score | 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. | Baseline, Mid Treatment (week 6), End of Treatment (week 12), Follow-up 1 (week 15), Follow-up 2 (week 18) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive-behavior therapy, d-cycloserine, cognitive enhancer, drug dependence, opiate dependence, exposure, isolated doses of d-cycloserine, isolated doses of matching pill placebo, DCS