Clinical trial NCT00827281: D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation (DCSSmoking)
Official title: D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Smokers
Keywords: DCS
CBT
smoking
tobacco
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Carbon monoxide analysis
timeFrame: Baseline, Weeks 4, 5, 6, 7, 8, 9, 13, 21, & 29
measure: Cotinine levels in saliva
timeFrame: Baseline, Weeks 21 & 29
Secondary outcomes:
measure: Anxiety Sensitivity Index
timeFrame: Baseline, Weeks 5, 6, 7, 8, 9, 13, 21 & 29
measure: Minnesota Withdrawal Scale
timeFrame: Each visit
measure: Mood & Anxiety Symptom Questionnaire
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, & 8
measure: Smoking Cessation Self-Efficacy
timeFrame: Baseline, Weeks 3, 4, 5, 6, 7, 8, 9, 13, 21 & 29
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
References: