NCT00387049

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

October 22, 2010

Status Verified

October 1, 2006

Enrollment Period

4.6 years

First QC Date

October 10, 2006

Last Update Submit

October 21, 2010

Conditions

Smoking Cessation

Keywords

Anxiety Sensitivity

Outcome Measures

Primary Outcomes (5)

  • Smoking status

    2 weeks post Quit Day

  • Smoking status

    4 weeks post Quit Day

  • Smoking status

    8 weeks post Quit Day

  • Smoking status

    16 weeks post Quit Day

  • Smoking status

    24 weeks post Quit Day

Secondary Outcomes (1)

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

    Determined at conclusion of study

Study Arms (2)

Anxiety-specific smoking cessation care

EXPERIMENTAL
Behavioral: Anxiety Sensitivity Program for Smoking Cessation

Standard smoking cessation care

ACTIVE COMPARATOR
Behavioral: Anxiety Sensitivity Program for Smoking Cessation

Interventions

Anxiety Sensitivity Program for Smoking CessationBEHAVIORAL
Anxiety-specific smoking cessation careStandard smoking cessation care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Michael J. Zvolensky, Ph.D.

    University of Vermont, Department of Psychology

    PRINCIPAL INVESTIGATOR

  • Andrew R. Yartz, Ph.D.

    University of Vermont, Department of Psychology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 12, 2006

Study Start

January 1, 2005

Primary Completion

August 1, 2009

Study Completion

April 1, 2010

Last Updated

October 22, 2010

Record last verified: 2006-10

Locations

US(1)