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

Substance-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00430573
• Other study ID #: R01 DA017904-S1
• Secondary ID: R01DA017904
• Status: Terminated
• Phase: Phase 2
• Start date: February 2007
• Est. completion date: June 2009

Study information

• Verified date: May 2018
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

Drug:
• D-cycloserine
Single dosage of D-cycloserine is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)
• Placebo
Single dosage of placebo is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)

Locations

Country	Name	City	State
United States	Habit OPCO	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston University Charles River Campus	Massachusetts General Hospital, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)