D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation (DCSSmoking)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2013 by Boston University.
Recruitment status was Active, not recruiting
Information provided by (Responsible Party):
Michael Otto, Boston University
First received: January 21, 2009
Last updated: May 23, 2013
Last verified: April 2013
This study examines whether isolated doses of D-cycloserine enhance the efficacy of CBT for smoking cessation.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation
Primary Outcome Measures:
- Carbon monoxide analysis [ Time Frame: Baseline, Weeks 4, 5, 6, 7, 8, 9, 13, 21, & 29 ] [ Designated as safety issue: No ]
- Cotinine levels in saliva [ Time Frame: Baseline, Weeks 21 & 29 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Anxiety Sensitivity Index [ Time Frame: Baseline, Weeks 5, 6, 7, 8, 9, 13, 21 & 29 ] [ Designated as safety issue: No ]
- Minnesota Withdrawal Scale [ Time Frame: Each visit ] [ Designated as safety issue: No ]
- Mood & Anxiety Symptom Questionnaire [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, & 8 ] [ Designated as safety issue: No ]
- Smoking Cessation Self-Efficacy [ Time Frame: Baseline, Weeks 3, 4, 5, 6, 7, 8, 9, 13, 21 & 29 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2014 (Final data collection date for primary outcome measure)
DCS-augmented CBT for smoking cessation
Single dosage prior to sessions 3, 4 & 5
Other Name: DCS
Placebo Comparator: 2
Placebo-augmented CBT for smoking cessation
Single dosage prior to sessions 3, 4 & 5
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.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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).
- 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).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00827281
|Boston, Massachusetts, United States, 02215 |
No publications provided
||Michael Otto, Ph.D., Boston University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 21, 2009
||May 23, 2013
||United States: Federal Government
Keywords provided by Boston University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 16, 2015
Anti-Infective Agents, Urinary
Molecular Mechanisms of Pharmacological Action