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Anxiety Sensitivity Program for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
University of Vermont
ClinicalTrials.gov Identifier:
NCT00387049
First received: October 10, 2006
Last updated: October 21, 2010
Last verified: October 2006
History of Changes
  Purpose

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.


Condition Intervention
Smoking Cessation
 Behavioral: Anxiety Sensitivity Program for Smoking Cessation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anxiety Sensitivity Program for Smoking Cessation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Smoking status [ Time Frame: 2 weeks post Quit Day ] [ Designated as safety issue: No ]
  • Smoking status [ Time Frame: 4 weeks post Quit Day ] [ Designated as safety issue: No ]
  • Smoking status [ Time Frame: 8 weeks post Quit Day ] [ Designated as safety issue: No ]
  • Smoking status [ Time Frame: 16 weeks post Quit Day ] [ Designated as safety issue: No ]
  • Smoking status [ Time Frame: 24 weeks post Quit Day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Where applicable, length of time from Quit Day to relapse. [ Time Frame: Determined at conclusion of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2005
Study Completion Date: April 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anxiety-specific smoking cessation care Behavioral: Anxiety Sensitivity Program for Smoking Cessation
Active Comparator: Standard smoking cessation care Behavioral: Anxiety Sensitivity Program for Smoking Cessation

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387049

Locations
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Michael J. Zvolensky, Ph.D. University of Vermont, Department of Psychology
Study Director: Andrew R. Yartz, Ph.D. University of Vermont, Department of Psychology
  More Information

No publications provided

Responsible Party: Ruth Farrell/Associate Vice President, University of Vermont
ClinicalTrials.gov Identifier: NCT00387049     History of Changes
Other Study ID Numbers: R01-DA018734, R01DA018734
Study First Received: October 10, 2006
Last Updated: October 21, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Vermont:
Anxiety Sensitivity

Additional relevant MeSH terms:
Anxiety Disorders
Smoking
Mental Disorders
Habits

ClinicalTrials.gov processed this record on May 16, 2013