Clinical trial NCT00430573: Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use
Official title: Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Substance-Related Disorders
Keywords: cognitive-behavior therapy
d-cycloserine
cognitive enhancer
drug dependence
opiate dependence
exposure
isolated doses of d-cycloserine
isolated doses of matching pill placebo
DCS
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Massachusetts General Hospital
First posted: 2007-02-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

The primary selection criteria include women and men between the ages of 18 and 65 who:

1. Meet DSM-IV criteria for opiate dependence,
2. 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.
3. Meet study criteria for chronic stress:

   * unemployment criteria, and
   * affective disorder criteria.

Exclusion Criteria:

1. 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).
2. Patients with a psychotic or organic mental disorder according to DSM-IV criteria.
3. Patients receiving medication affecting methadone metabolism (e.g. rifampin).
4. 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).
5. Patients unable to complete the informed consent or unable to understand study procedures in the informed consent process.
6. Pregnancy or current alcohol use.

Primary outcomes:
measure: Percentage of Positive Toxicology Swabs for Illicit Substances
timeFrame: Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18)
Secondary outcomes:
measure: Addiction Severity Index (ASI) Drug Use Composite Score
timeFrame: Baseline, Mid Treatment (week 6), End of Treatment (week 12), Follow-up 1 (week 15), Follow-up 2 (week 18)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Habit OPCO
state: Massachusetts
Study officials:
affiliation: Boston University
name: Michael W. Otto, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: