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

Information source: Boston University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Smokers

Intervention: D-cycloserine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Boston University

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Carbon monoxide analysis

Cotinine levels in saliva

Secondary outcome:

Anxiety Sensitivity Index

Minnesota Withdrawal Scale

Mood & Anxiety Symptom Questionnaire

Smoking Cessation Self-Efficacy

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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).

Locations and Contacts

Boston University, Boston, Massachusetts 02215, United States
Additional Information

Starting date: August 2008
Last updated: July 20, 2015

Page last updated: August 23, 2015

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