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Completed

NCT Number: NCT00387049

Anxiety Sensitivity Program for Smoking Cessation

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont

Burlington, Vermont, 05405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anxiety Sensitivity Program for Smoking Cessation

Behavioral

Primary outcomes

  1. Smoking status

    Time frame: 2 weeks post Quit Day

  2. Smoking status

    Time frame: 4 weeks post Quit Day

  3. Smoking status

    Time frame: 8 weeks post Quit Day

  4. Smoking status

    Time frame: 16 weeks post Quit Day

  5. Smoking status

    Time frame: 24 weeks post Quit Day

Secondary outcomes

  1. Where applicable, length of time from Quit Day to relapse.

    Time frame: Determined at conclusion of study

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Oct 12, 2006
Registry last updated
Oct 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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