Anxiety Sensitivity Program for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Anxiety Sensitivity Program for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00387049
• Other study ID #: R01DA018734
• Secondary ID: R01DA018734
• Status: Completed
• Phase: N/A
• First received: October 10, 2006
• Last updated: October 21, 2010
• Start date: January 2005
• Est. completion date: April 2010

Study information

• Verified date: October 2006
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Anxiety Sensitivity Program for Smoking Cessation

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking status		2 weeks post Quit Day	No
Primary	Smoking status		4 weeks post Quit Day	No
Primary	Smoking status		8 weeks post Quit Day	No
Primary	Smoking status		16 weeks post Quit Day	No
Primary	Smoking status		24 weeks post Quit Day	No
Secondary	Where applicable, length of time from Quit Day to relapse.		Determined at conclusion of study	No