D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation (DCSSmoking)

NCT ID: NCT00827281

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2015-07-15

Brief Summary

This study examines whether isolated doses of D-cycloserine enhance the efficacy of CBT for smoking cessation.

Detailed Description

In comparison to placebo-augmented cognitive behavioral therapy (CBT), D-cycloserine-augmented CBT will lead to a greater reduction in both short-and long-term point prevalence abstinence as well as time to first smoking lapse and time to smoking relapse.

Conditions

Smokers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

DCS-augmented CBT for smoking cessation

Group Type: EXPERIMENTAL

D-cycloserine

Intervention Type: DRUG

Single dosage prior to sessions 3, 4 \& 5

2

Placebo-augmented CBT for smoking cessation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single dosage prior to sessions 3, 4 \& 5

Interventions

D-cycloserine

Single dosage prior to sessions 3, 4 \& 5

Intervention Type: DRUG

Placebo

Single dosage prior to sessions 3, 4 \& 5

Intervention Type: DRUG

Other Intervention Names

DCS

Eligibility Criteria

Inclusion Criteria

1. Be a regular smoker for at least one year 3. Currently smoke an average of at least 10 cigarettes per day 4. Report a motivation to quit smoking in the next month of at least 5 on a 10 point scale 5. Score 20 or greater on the 16-item Anxiety Sensitivity Index (Schmidt & Joiner, 2002).

Exclusion Criteria

1. Current diagnosis of a psychotic, eating, developmental or bipolar disorder (as determined by the SCID)

2. Current anxiety or mood disorder rated moderate or greater (i.e., CGI score of 4 or greater for an anxiety or depressive disorder or any current or recent-1 year--suicidal ideation)

3. Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 6 months

4. Current use of isoniazid psychotropic medication

5. A history of significant medical condition, such as cardiovascular, neurologic, gastrointestinal, pregnancy and/or breast feeding, history of seizure (other than febrile seizures in childhood) or other systemic illness and/or be deemed as currently unhealthy in the context of a complete physical examination

6. Limited mental competency and the inability to give informed, voluntary, written consent to participate,

7. Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt,

8. Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of anxiety or mood disorder other than general supportive therapy initiated at least 3 months prior to the study

9. Use of other tobacco products

10. Planning on moving (outside of the immediate area) in the next six months

11. Insufficient command of the English language (i.e., they cannot carry on a conversation with an interviewer in the English language or read associated text).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Michael Otto

Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Boston University

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

1728

Identifier Type: -

Identifier Source: org_study_id