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

NCT00430573 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: R01 DA017904-S1R01DA017904
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Addiction Severity Index (ASI) Drug Use Composite Score

  Baseline, Mid Treatment (week 6), End of Treatment (week 12), Follow-up 1 (week 15), Follow-up 2 (week 18)

Study Arms (2)

DCS-augmented CBT-IC

EXPERIMENTAL

D-cycloserine-augmented CBT-IC

Drug: D-cycloserine

Placebo-augmented CBT-IC

PLACEBO COMPARATOR

Placebo-augmented CBT-IC

Drug: Placebo

Interventions

D-cycloserine DRUG

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

Also known as: DCS

DCS-augmented CBT-IC

Placebo DRUG

Single dosage of placebo is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)

Placebo-augmented CBT-IC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Habit OPCO

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Study was terminated due to low enrollment/adherence with the study drug. 10 participants were randomized, 5 dropped out before taking study drug. The blind was never broken so results can only be presented aggregated for all randomized participants.

Results Point of Contact

• Title: Michael W. Otto, Ph.D.
• Organization: BostonUCRC

mwotto@bu.edu

(617)353-9610

Study Officials

• Michael W. Otto, Ph.D.

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: January 31, 2007
• First Posted: February 2, 2007
• Study Start: February 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 17, 2018
• Results First Posted: May 17, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)