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

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

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.

Study Overview

• Status: Terminated
• Conditions: Substance-Related Disorders
• Intervention / Treatment: Drug: D-cycloserine; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Habit OPCO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Collaborators: National Institute on Drug Abuse (NIDA); Massachusetts General Hospital
• Investigators: Principal Investigator: Michael W. Otto, Ph.D., Boston University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: January 31, 2007
• First Submitted That Met QC Criteria: February 1, 2007
• First Posted (Estimate): February 2, 2007

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: exposure; opiate dependence; drug dependence; cognitive-behavior therapy; d-cycloserine; DCS; cognitive enhancer; isolated doses of d-cycloserine; isolated doses of matching pill placebo
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antimetabolites; Anti-Bacterial Agents; Antitubercular Agents; Antibiotics, Antitubercular; Anti-Infective Agents, Urinary; Renal Agents; Cycloserine
• Other Study ID Numbers: R01 DA017904-S1; R01DA017904 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes