Coping Skills Treatment for Smoking Cessation
- Registration Number
- NCT01061528
- Lead Sponsor
- Butler Hospital
- Brief Summary
The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments, participants will receive one 60-minute individual session, seven 2-hour group sessions and two individual brief telephone contacts over an eight-week period. Both treatments include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after the treatment sessions have ended. Participants will provide follow-up data with regard to their smoking status through a one-year follow-up period.
- Detailed Description
1. 18-65 years of age,
2. a regular smoker for at least one year,
3. currently smoking 10 or more cigarettes per day,
4. report motivation to quit smoking in the next month.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- 18-65 years old
- regular smoker for at least one year
- currently smoking 10 or more cigarettes per day
- Current Axis I disorder
- Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year
- Current suicidal risk
- Pregnancy or breast feeding
- Use of nicotine replacement products or bupropion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description New Smoking Cessation Counseling Transdermal Nicotine * One 60-minute individual session * Seven 2-hour group sessions * Two individual brief telephone contacts over an eight-week period. * Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used. Standard Smoking Cessation Counseling Transdermal Nicotine * One 60-minute individual session * Seven 2-hour group sessions * Two individual brief telephone contacts over an eight-week period. * Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
- Primary Outcome Measures
Name Time Method Number of Participants With Biochemically Verified Smoking Abstinence Six months 1. Carbon monoxide of expired air
2. Salivary cotinine level of saliva
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Butler Hospital
🇺🇸Providence, Rhode Island, United States