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
  Purpose

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


Condition Intervention Phase
Smokers
Drug: D-cycloserine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Boston University:

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: 192
Study Start Date: August 2008
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
DCS-augmented CBT for smoking cessation
Drug: D-cycloserine
Single dosage prior to sessions 3, 4 & 5
Other Name: DCS
Placebo Comparator: 2
Placebo-augmented CBT for smoking cessation
Drug: Placebo
Single dosage prior to sessions 3, 4 & 5

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827281

Locations
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston University
  More Information

No publications provided

Responsible Party: Michael Otto, Ph.D., Boston University
ClinicalTrials.gov Identifier: NCT00827281     History of Changes
Other Study ID Numbers: 1728
Study First Received: January 21, 2009
Last Updated: May 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Boston University:
DCS
CBT
smoking
tobacco

Additional relevant MeSH terms:
Smoking
Habits
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014