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

Phase 2

Withdrawn

• Conditions: Smokers
• Interventions: Drug: Placebo; Drug: D-cycloserine

• Registration Number: NCT00827281
• Lead Sponsor: Boston University Charles River Campus

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Primary Completion: 2015-07-15
• Study Completion: 2015-07-15
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo-augmented CBT for smoking cessation
1	D-cycloserine	DCS-augmented CBT for smoking cessation

Primary Outcome Measures

Name	Time	Method
Cotinine levels in saliva	Baseline, Weeks 21 & 29
Carbon monoxide analysis	Baseline, Weeks 4, 5, 6, 7, 8, 9, 13, 21, & 29

Secondary Outcome Measures

Name	Time	Method
Anxiety Sensitivity Index	Baseline, Weeks 5, 6, 7, 8, 9, 13, 21 & 29
Minnesota Withdrawal Scale	Each visit
Mood & Anxiety Symptom Questionnaire	Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, & 8
Smoking Cessation Self-Efficacy	Baseline, Weeks 3, 4, 5, 6, 7, 8, 9, 13, 21 & 29

Trial Locations

Locations (1)

Boston University; 🇺🇸 Boston, Massachusetts, United States