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

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

Detailed Description
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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.

Official Title
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D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation

Conditions
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Smokers

Intervention / Treatment
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* Drug: D-cycloserine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: Current diagnosis of a psychotic, eating, developmental or bipolar disorder (as determined by the SCID) 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) Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 6 months Current use of isoniazid psychotropic medication 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 Limited mental competency and the inability to give informed, voluntary, written consent to participate, Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt, 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 Use of other tobacco products Planning on moving (outside of the immediate area) in the next six months 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>DCS-augmented CBT for smoking cessation | Drug: D-cycloserine<br>* Single dosage prior to sessions 3, 4 & 5<br>* Other names: DCS;|
| Placebo Comparator: 2<br>Placebo-augmented CBT for smoking cessation | Drug: Placebo<br>* Single dosage prior to sessions 3, 4 & 5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbon monoxide analysis |  | Baseline, Weeks 4, 5, 6, 7, 8, 9, 13, 21, & 29 | 
| Cotinine levels in saliva |  | Baseline, Weeks 21 & 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DCS, CBT, smoking, tobacco