Anxiety Sensitivity Program for Smoking Cessation

NCT ID: NCT00387049

Last Updated: 2010-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anxiety-specific smoking cessation care

Group Type EXPERIMENTAL

Anxiety Sensitivity Program for Smoking Cessation

Intervention Type BEHAVIORAL

Standard smoking cessation care

Group Type ACTIVE_COMPARATOR

Anxiety Sensitivity Program for Smoking Cessation

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anxiety Sensitivity Program for Smoking Cessation

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Vermont

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Vermont

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael J. Zvolensky, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Vermont, Department of Psychology

Andrew R. Yartz, Ph.D.

Role: STUDY_DIRECTOR

University of Vermont, Department of Psychology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Vermont

Burlington, Vermont, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01DA018734

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01DA018734

Identifier Type: NIH

Identifier Source: org_study_id

View Link