Coping Skills Treatment for Smoking Cessation

Study Overview
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Brief Summary
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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
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18-65 years of age, a regular smoker for at least one year, currently smoking 10 or more cigarettes per day, report motivation to quit smoking in the next month.

Official Title
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Distress Tolerance Treatment for Smoking Cessation

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Drug: Transdermal Nicotine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old regular smoker for at least one year currently smoking 10 or more cigarettes per day Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Smoking Cessation Counseling<br>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. | Drug: Transdermal Nicotine<br>* Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.<br>* Other names: Nicoderm CQ;|
| Active Comparator: Standard Smoking Cessation Counseling<br>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. | Drug: Transdermal Nicotine<br>* Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.<br>* Other names: Nicoderm CQ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Biochemically Verified Smoking Abstinence | Carbon monoxide of expired air Salivary cotinine level of saliva | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cigarette smoking, smoking cessation, nicotine dependence