Anxiety Sensitivity Program for Smoking Cessation

Study Overview
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Brief Summary
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The purpose of this study is to develop and test a smoking cessation intervention for persons who are specifically sensitive to anxiety and anxiety-related bodily sensations.

Official Title
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Anxiety Sensitivity Program for Smoking Cessation

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Anxiety Sensitivity Program for Smoking Cessation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 65 years old Not pregnant Regular smoker averaging 10 or more cigarettes per day for at least one year Score of 25 or greater on 16-item Anxiety Sensitivity Index Motivation to Quit score of 7 or greater (using Readiness to Quit Ladder) Not currently using pharmacotherapy for smoking cessation (e.g., Zyban) No use of other tobacco products (e.g., chewing tobacco, cigars) No Axis-I or Axis-II diagnoses other than mood or anxiety disorders (intake interview required) No suicidal or homicidal ideation No current psychotropic medication use No evidence of substance abuse or dependence (other than nicotine dependence) No history of significant medical conditions (cardiovascular, neurological, etc.) Ability to provide informed, written consent (no evidence of limited mental capacity) Sufficient command of the English language (able to carry on interview conversation) Plan to stay in Burlington VT area for at least next 6 months Exclusion Criteria: Not between 18-65 years old Pregnant or currently trying to become pregnant Regular smoker for less than one year OR smoke less than 10 cigarettes per day ASI below cutoff level of 25 Motivation to Quit score of 6 or less (using Readiness to Quit Ladder) Current or recent use of any pharmacotherapy for smoking cessation (e.g., patch, Zyban) Current use of other tobacco products (e.g., chewing tobacco, cigars) Axis-I disorders other than anxiety or mood disorders. Endorsement of suicidality or homicidal ideation. Any current psychotropic medication use (must have stopped at least 1 month prior). Any evidence of substance abuse or dependence (other than nicotine dependence) Any history of significant medical conditions (cardiovascular, neurological, etc.) Inability to provide informed, written consent (evidence of limited mental capacity) Insufficient command of the English language (unable to carry on conversation) Plan to permanently leave Burlington area anytime during the next 6-12 months

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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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anxiety-specific smoking cessation care<br> | Behavioral: Anxiety Sensitivity Program for Smoking Cessation<br> <br> |
| Active Comparator: Standard smoking cessation care<br> | Behavioral: Anxiety Sensitivity Program for Smoking Cessation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking status |  | 2 weeks post Quit Day | 
| Smoking status |  | 4 weeks post Quit Day | 
| Smoking status |  | 8 weeks post Quit Day | 
| Smoking status |  | 16 weeks post Quit Day | 
| Smoking status |  | 24 weeks post Quit Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Where applicable, length of time from Quit Day to relapse. |  | Determined at conclusion of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety Sensitivity