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

Smokers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00827281
• Other study ID #: 1728
• Status: Withdrawn
• Phase: Phase 2
• First received: January 21, 2009
• Last updated: April 28, 2017
• Start date: August 2008
• Est. completion date: July 15, 2015

Study information

• Verified date: April 2017
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 15, 2015
• Est. primary completion date: July 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Smokers

Intervention

Drug:
• D-cycloserine
Single dosage prior to sessions 3, 4 & 5
• Placebo
Single dosage prior to sessions 3, 4 & 5

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University Charles River Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carbon monoxide analysis		Baseline, Weeks 4, 5, 6, 7, 8, 9, 13, 21, & 29
Primary	Cotinine levels in saliva		Baseline, Weeks 21 & 29
Secondary	Anxiety Sensitivity Index		Baseline, Weeks 5, 6, 7, 8, 9, 13, 21 & 29
Secondary	Minnesota Withdrawal Scale		Each visit
Secondary	Mood & Anxiety Symptom Questionnaire		Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, & 8
Secondary	Smoking Cessation Self-Efficacy		Baseline, Weeks 3, 4, 5, 6, 7, 8, 9, 13, 21 & 29