Back to resultsAnxiety Sensitivity Program for Smoking Cessation
Primary Purpose
Smoking Cessation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anxiety Sensitivity Program for Smoking Cessation
Sponsored by
About this trial
This is an interventional treatment trial for Smoking Cessation focused on measuring Anxiety Sensitivity
Eligibility Criteria
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
Sites / Locations
- University of Vermont
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Anxiety-specific smoking cessation care
Standard smoking cessation care
Arm Description
Outcomes
Primary Outcome Measures
Smoking status
Smoking status
Smoking status
Smoking status
Smoking status
Secondary Outcome Measures
Where applicable, length of time from Quit Day to relapse.
Full Information
NCT ID
NCT00387049
First Posted
October 10, 2006
Last Updated
October 21, 2010
Sponsor
University of Vermont
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00387049
Brief Title
Anxiety Sensitivity Program for Smoking Cessation
Official Title
Anxiety Sensitivity Program for Smoking Cessation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Vermont
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation
Keywords
Anxiety Sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anxiety-specific smoking cessation care
Arm Type
Experimental
Arm Title
Standard smoking cessation care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Anxiety Sensitivity Program for Smoking Cessation
Primary Outcome Measure Information:
Title
Smoking status
Time Frame
2 weeks post Quit Day
Title
Smoking status
Time Frame
4 weeks post Quit Day
Title
Smoking status
Time Frame
8 weeks post Quit Day
Title
Smoking status
Time Frame
16 weeks post Quit Day
Title
Smoking status
Time Frame
24 weeks post Quit Day
Secondary Outcome Measure Information:
Title
Where applicable, length of time from Quit Day to relapse.
Time Frame
Determined at conclusion of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J. Zvolensky, Ph.D.
Organizational Affiliation
University of Vermont, Department of Psychology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew R. Yartz, Ph.D.
Organizational Affiliation
University of Vermont, Department of Psychology
Official's Role
Study Director
Facility Information:
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Anxiety Sensitivity Program for Smoking Cessation
We'll reach out to this number within 24 hrs