D-cycloserine (DCS) Pretreatment + CBT + Nicotine Replacement Therapy for Smoking Cessation (DCS)

NCT01842334 | Terminated Phase 1 Results

• 1 other identifier: 2012P001707
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Compare the relative efficacy of ten weeks of once weekly 250 mg D-cycloserine (DCS) vs. placebo (both in conjunction with cognitive behavioral therapy (CBT) and nicotine replacement therapy (NRT) on reducing cigarette smoking in treatment-seeking nicotine-dependent outpatients.
2. 2.Compare the relative efficacy of ten weeks of once weekly 250 mg DCS vs. placebo on the process of extinction and the memory encoding process.

Conditions

Nicotine Dependence; Smoking Cessation

Keywords

Nicotine Dependence; Smoking Cessation; D-cycloserine

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Cigarette Smoking in Treatment Seeking Nicotine Dependent Outpatients

  Cigarette smoking at 10 weeks as measured by carbon monoxide levels and self-report measurements.

  During Week 10

Study Arms (2)

D-cycloserine

EXPERIMENTAL

250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy.

Behavioral: Cognitive Behavioral Therapy; Drug: Nicotine Replacement Therapy

Placebo

PLACEBO COMPARATOR

one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy

Behavioral: Cognitive Behavioral Therapy; Drug: Nicotine Replacement Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

CBT administered to to both DCS and placebo group.

Also known as: CBT

D-cycloserine; Placebo

Nicotine Replacement Therapy DRUG

NRT administered to both DCS and placebo group.

Also known as: NRT

D-cycloserine; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Age range 18-65 years; 2) DSM-IV diagnosis of nicotine dependence, based on the Structured Clinical Interview for DSM-IV (SCID) (First et al. 1996); 3) express a desire to quit cigarette smoking within the next 30 days; 4) smokes greater than or equal to 10 cigarettes per day and less than or equal to 20 cigarettes per day; 5) an expired carbon monoxide (CO) determination greater than or equal to 10 ppm over ambient values; 6) for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and multiple subsequent pregnancy tests; 7) consent for us to communicate with their prescribing clinician; 8) furnish the names of 2 locators, who would assist study staff in locating them during the study period; 9) live close enough to McLean Hospital to attend study visits; 10) plan to remain in the Boston area for the next 4 months; and 11) are willing and able to sign informed consent.

Sponsors & Collaborators

• Mclean Hospital: lead
• American Lung Association: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

Cognitive Behavioral Therapy; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Drug Therapy; Therapeutics

Limitations and Caveats

Due to lack of sufficient funds/resources, the sample size for this study is not large enough to extract any conclusive results. The high number of subjects withdrawing from the study early also hinders any possible conclusions.

Results Point of Contact

• Title: Dr. Kevin P Hill, Director of the Division of Addiction Psychiatry
• Organization: Beth Israel Deaconess Medical Center

khill1@bidmc.harvard.edu

617-667-1504

Study Officials

• Kevin P. Hill, MD, MHS

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: April 25, 2013
• First Posted: April 29, 2013
• Study Start: April 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 31, 2018
• Results First Posted: August 1, 2018

Record last verified: 2018-08

Locations

US (1)