Tobacco Use Disorder Clinical Trial
Official title:
Nicotine Patch Pre-treatment for Smoking Cessation in PTSD
Verified date | November 2014 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
This study seeks to evaluate the relationship between PTSD, abstinence, and factors associated with relapse in the context of a randomized, clinical smoking cessation trial.
Status | Completed |
Enrollment | 87 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Smokers who smoke 10 or more cigarettes per day in the past year; - 18-80 years old; - English speakers; - medically stable; - stable on current medication regimen Exclusion Criteria: - Pregnant women excluded; - participants with organic mental disorder, schizophrenia, bipolar disorder, lifetime but not current PTSD, current substance abuse or dependence; - medical conditions contraindicated with nicotine replacement therapy; - use other forms of nicotine (cigars, nicotine gum, etc.) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | VA Medical Center, Durham | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Smoking Abstinence, Self-reported | Number of participants by group reporting 1 week of self-reported abstinence in the week prior to Session 12 at six weeks post-treatment | Week prior to Session 12 at 6 weeks post-treatment | No |
Secondary | Carbon Monoxide Monitoring | Number of participants whose carbon monoxide (CO) measurement indicated abstinence at Session 12 (6 weeks post-treatment) | Session 12 (6 weeks post-treatment) | No |
Secondary | Smoking Craving | Mean smoking craving score (as measured during daily ecological momentary, or diary, assessments) for participants by group during the two week period of placebo/active pre-treatment. This is the main period of interest, as it was hypothesized that use of active nicotine patch would reduce smoking cravings during the pre-quit period. The craving score is based on a single diary item "Please rate your desire to smoke right now" with a Likert scale score ranging from 1 (none) to 5 (severe). Higher craving is "worse," as lower craving is presumed to reflect decreased risk of smoking lapse or relapse. | Daily between visits 2-12 | No |
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