Clinical trial NCT00387049: Anxiety Sensitivity Program for Smoking Cessation
Official title: Anxiety Sensitivity Program for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Anxiety Sensitivity
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2006-10-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Aged between 18 and 65 years old
2. Not pregnant
3. Regular smoker averaging 10 or more cigarettes per day for at least one year
4. Score of 25 or greater on 16-item Anxiety Sensitivity Index
5. Motivation to Quit score of 7 or greater (using Readiness to Quit Ladder)
6. Not currently using pharmacotherapy for smoking cessation (e.g., Zyban)
7. No use of other tobacco products (e.g., chewing tobacco, cigars)
8. No Axis-I or Axis-II diagnoses other than mood or anxiety disorders (intake interview required)
9. No suicidal or homicidal ideation
10. No current psychotropic medication use
11. No evidence of substance abuse or dependence (other than nicotine dependence)
12. No history of significant medical conditions (cardiovascular, neurological, etc.)
13. Ability to provide informed, written consent (no evidence of limited mental capacity)
14. Sufficient command of the English language (able to carry on interview conversation)
15. Plan to stay in Burlington VT area for at least next 6 months

Exclusion Criteria:

1. Not between 18-65 years old
2. Pregnant or currently trying to become pregnant
3. Regular smoker for less than one year OR smoke less than 10 cigarettes per day
4. ASI below cutoff level of 25
5. Motivation to Quit score of 6 or less (using Readiness to Quit Ladder)
6. Current or recent use of any pharmacotherapy for smoking cessation (e.g., patch, Zyban)
7. Current use of other tobacco products (e.g., chewing tobacco, cigars)
8. Axis-I disorders other than anxiety or mood disorders.
9. Endorsement of suicidality or homicidal ideation.
10. Any current psychotropic medication use (must have stopped at least 1 month prior).
11. Any evidence of substance abuse or dependence (other than nicotine dependence)
12. Any history of significant medical conditions (cardiovascular, neurological, etc.)
13. Inability to provide informed, written consent (evidence of limited mental capacity)
14. Insufficient command of the English language (unable to carry on conversation)
15. Plan to permanently leave Burlington area anytime during the next 6-12 months

Primary outcomes:
measure: Smoking status
timeFrame: 2 weeks post Quit Day
measure: Smoking status
timeFrame: 4 weeks post Quit Day
measure: Smoking status
timeFrame: 8 weeks post Quit Day
measure: Smoking status
timeFrame: 16 weeks post Quit Day
measure: Smoking status
timeFrame: 24 weeks post Quit Day
Secondary outcomes:
measure: Where applicable, length of time from Quit Day to relapse.
timeFrame: Determined at conclusion of study
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont, Department of Psychology
name: Michael J. Zvolensky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont, Department of Psychology
name: Andrew R. Yartz, Ph.D.
role: STUDY_DIRECTOR
References: