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

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ClinicalTrials.gov Identifier: NCT00827281
Recruitment Status : Withdrawn (Study was not funded and pilot work proved impractical.)
First Posted : January 22, 2009
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Otto, Boston University Charles River Campus

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

Condition or disease Intervention/treatment Phase
Smokers Drug: D-cycloserine Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation
Actual Study Start Date : August 2008
Actual Primary Completion Date : July 15, 2015
Actual Study Completion Date : July 15, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Carbon monoxide analysis [ Time Frame: Baseline, Weeks 4, 5, 6, 7, 8, 9, 13, 21, & 29 ]
  2. Cotinine levels in saliva [ Time Frame: Baseline, Weeks 21 & 29 ]

Secondary Outcome Measures :
  1. Anxiety Sensitivity Index [ Time Frame: Baseline, Weeks 5, 6, 7, 8, 9, 13, 21 & 29 ]
  2. Minnesota Withdrawal Scale [ Time Frame: Each visit ]
  3. Mood & Anxiety Symptom Questionnaire [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, & 8 ]
  4. Smoking Cessation Self-Efficacy [ Time Frame: Baseline, Weeks 3, 4, 5, 6, 7, 8, 9, 13, 21 & 29 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827281


Locations
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston University Charles River Campus

Responsible Party: Michael Otto, Ph.D., Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT00827281     History of Changes
Other Study ID Numbers: 1728
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017

Keywords provided by Michael Otto, Boston University Charles River Campus:
DCS
CBT
smoking
tobacco

Additional relevant MeSH terms:
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action