D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation (DCSSmoking)
This study is ongoing, but not recruiting participants.
Sponsor:
Boston University
Information provided by (Responsible Party):
Michael Otto, Boston University
ClinicalTrials.gov Identifier:
NCT00827281
First received: January 21, 2009
Last updated: April 18, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 National Institute on Drug Abuse (NIDA):
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:
- 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).
Contacts and Locations
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: | April 18, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute on Drug Abuse (NIDA):
|
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 May 19, 2013