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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michael Otto, Boston University
ClinicalTrials.gov Identifier:
NCT00827281
First received: January 21, 2009
Last updated: May 23, 2013
Last verified: April 2013

January 21, 2009
May 23, 2013
August 2008
January 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00827281 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation (DCSSmoking)
D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Smokers
  • Drug: D-cycloserine
    Single dosage prior to sessions 3, 4 & 5
    Other Name: DCS
  • Drug: Placebo
    Single dosage prior to sessions 3, 4 & 5
  • Experimental: 1
    DCS-augmented CBT for smoking cessation
    Intervention: Drug: D-cycloserine
  • Placebo Comparator: 2
    Placebo-augmented CBT for smoking cessation
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
192
January 2014
January 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00827281
1728
No
Michael Otto, Boston University
Boston University
Not Provided
Not Provided
Boston University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP