Anxiety Sensitivity Program for Smoking Cessation

University of Vermont

Status: Completed

Conditions: Smoking Cessation

Treatments: Behavioral: Anxiety Sensitivity Program for Smoking Cessation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00387049

R01DA018734 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Anxiety-specific smoking cessation care

Experimental group

Treatment:

Behavioral: Anxiety Sensitivity Program for Smoking Cessation

Standard smoking cessation care

Active Comparator group

Treatment:

Behavioral: Anxiety Sensitivity Program for Smoking Cessation