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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00430573
Recruitment Status : Terminated (The investigators failed to recruit participants as originally projected.)
First Posted : February 2, 2007
Results First Posted : May 17, 2018
Last Update Posted : May 17, 2018
National Institute on Drug Abuse (NIDA)
Massachusetts General Hospital
Information provided by (Responsible Party):
Michael Otto, Boston University Charles River Campus

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.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Drug: D-cycloserine Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use
Actual Study Start Date : February 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse
Drug Information available for: Cycloserine

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 Name: DCS

Placebo Comparator: Placebo-augmented CBT-IC
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)

Primary Outcome Measures :
  1. Percentage of Positive Toxicology Swabs for Illicit Substances [ Time Frame: 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 :
  1. Addiction Severity Index (ASI) Drug Use Composite Score [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00430573

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United States, Massachusetts
Habit OPCO
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University Charles River Campus
National Institute on Drug Abuse (NIDA)
Massachusetts General Hospital
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Principal Investigator: Michael W. Otto, Ph.D. Boston University

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Responsible Party: Michael Otto, Ph.D., Boston University Charles River Campus Identifier: NCT00430573    
Other Study ID Numbers: R01 DA017904-S1
R01DA017904 ( U.S. NIH Grant/Contract )
First Posted: February 2, 2007    Key Record Dates
Results First Posted: May 17, 2018
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Michael Otto, Boston University Charles River Campus:
cognitive-behavior therapy
cognitive enhancer
drug dependence
opiate dependence
isolated doses of d-cycloserine
isolated doses of matching pill placebo
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action