Smoking Cessation Clinical Trial
Official title:
Behavioral Activation for Smoking Cessation in Veterans With PTSD
Verified date | March 2017 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to examine whether behavioral activation as an adjuvant to standard smoking cessation treatment improves smoking cessation outcomes among veterans with PTSD relative to a comparably intense combination of standard smoking cessation treatment + health and smoking education. It is expected that behavioral activation will produce more successful results than health and smoking education when paired with standard smoking cessation treatment.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | September 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Report smoking an average of 10 or more cigarettes daily for at least six months - Report a desire to quit smoking - Meet criteria for current PTSD - Speak and read English - Agree to participate in the study - Be = 18 years old - Be a veteran Exclusion Criteria: - Meeting criteria for psychotic or bipolar disorder - Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 6 months - Inability to give informed, voluntary, written consent to participate - Current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt - Use of non-cigarette tobacco products as a primary form of tobacco use - Being currently suicidal or homicidal - Being medically unable to use the nicotine patch or nicotine gum/lozenge - Psychotropic medication changes within 3 months of study initiation and during active treatment - Current engagement in evidence-based therapies for PTSD or depression - Pregnant or trying to become pregnant - Incarceration |
Country | Name | City | State |
---|---|---|---|
United States | William S. Middleton Memorial Veterans Hospital | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Abstinence from tobacco | 7-day point prevalence abstinence at 26 weeks post-quit (measured via single end-point analysis and via abstinence over time). | 26 weeks post target quit date | |
Secondary | Time to tobacco relapse | Time to first relapse after target quit date. | 26 weeks post target quit date | |
Secondary | PTSD symptoms | PTSD symptoms [as assessed with Clinician-Administered PTSD Scale (CAPS) interview that involves a clinician asking participants to rate PTSD symptoms on Likert Scales] 5 weeks following target quit date. | 5 weeks post target quit date (end of treatment) |
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