Preventing Relapse Following Involuntary Smoking Abstinence (AFV)

October 31, 2016 updated by: University of Tennessee

The prevalence of tobacco use in the military is too high. This study is designed to take advantage of the 8.5 weeks of forced tobacco cessation during Basic Military Training and develop effective interventions to prevent tobacco relapse.

Hypotheses or Research Questions:

  • Are there differences in the rate of relapse between three groups participating in a tobacco abstinence maintenance intervention?
  • Do the tobacco abstinence maintenance interventions delay relapse?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Consented subjects will be randomly assigned either to:(a) National Cancer Institute tobacco cessation pamphlet , to (b) Tailored relapse prevention pamphlet , or to (c) Tailored relapse prevention pamphlet + 1 proactive relapse prevention face-to-face meeting.

To determine the long-term (12 month) efficacy of the abstinence maintenance intervention. Our primary outcome is abstinence from tobacco products at the 12 month follow-up. A secondary outcome will be to determine if these interventions delay relapse among those who relapse to smoking or other tobacco use.

Significance: Cigarette smoking use is the number one preventable cause of morbidity and mortality in this nation (CDC, 1999; Mokdad et al., 2004). Preventing relapse is a high priority for those attempting to quit smoking as most people who attempt cessation relapse within a very short period of time (Fiore et al., 2000). Of smokers who receive a formal cessation program, at least 70% relapse (Fiore et al., 2000); among self quitters, the relapse rate is approximately 90% (Cohen et al., 1989). It is still the case, however, that the vast majority of smokers who try to stop smoking do so with no or with minimal assistance (Garvey et al., 1992).

While the vast majority of smokers try to quit on their own, surprisingly little research has been conducted on reducing relapse among self-quitters. Brandon and colleagues (2000, 2003, 2004) have demonstrated that a series of 8 self-help printed materials consistently produced higher point-prevalence abstinence rates in smokers that had quit on their own. Given the enormous public health implications of this approach, more research on promoting long-term self-quitting is clearly needed. In addition a number of never smokers actually start smoking shortly after accession into the Air Force (Klesges et. al., 1999; 2006). The goal of this research is to encourage all airmen to remain tobacco free. Because of this the investigators are encouraging all airmen to participate in the abstinence maintenance interventions.

Military Relevance: Virtually all research to date on promoting self-quitting has been conducted in samples where participants have voluntarily stopped smoking prior to participating in the interventions (Brandon et al., 2000, 2004). However, nothing is known about methods of preventing and delaying initiation following involuntary abstinence (e.g., military training, during hospital stays, in jails, prisons, & psychiatric facilities). Previous research (Klesges et al., 1999, 2006) has determined that protracted involuntary cessation in the military with no other intervention is associated with significant long-term cessation rates (15-20% at a one-year follow-up). To our knowledge, no study has successfully intervened to reduce relapse rates following a protracted involuntary abstinence (such as in Basic Military Training).

Study Type

Interventional

Enrollment (Anticipated)

23000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • University of Tennessee Health Science Center
    • Texas
      • Lackland AFB, Texas, United States, 78236
        • Wilford Hall Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Active duty Air Force personnel
  • Has smoked five or more cigarettes per day for at least 1 year before study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ban & Informational Pamphlet
Following 8.5 weeks of cessation subjects are given an informational pamphlet on tobacco cessation and relapse prevention.
Behavioral: Tobacco Use Ban
Airmen are restricted from use tobacco products during Basic Military Training which lasts for 8.5 weeks.
Other Names:
  • Tobacco Ban
Behavioral: Informational Pamphlet
The National Cancer Institute Pamphlet "Clearing the Air" was provided to subjects.
Other Names:
  • Tobacco cessation pamphlets
Experimental: Ban & Tailored Pamphlet
After 8.5 weeks of tobacco use cessation during Basic Military Training subjects are provided a tailored relapse prevention pamphlet inspired by Forever Free and tailored for use in the United States Air Force
Behavioral: Tobacco Use Ban
Airmen are restricted from use tobacco products during Basic Military Training which lasts for 8.5 weeks.
Other Names:
  • Tobacco Ban
Behavioral: Tailored Pamphlet
A tailored relapse prevention pamphlet inspired by Forever Free and tailored for use in the United States Air Force.
Other Names:
  • Tailored tobacco cessation information
Experimental: Ban & Tailored Pamphlet & Intervention
After 8.5 weeks of tobacco use cessation during Basic Military Training subjects are provided a tailored relapse prevention pamphlet inspired by Forever Free and tailored for use in the United States Air Force. In addition they are given a face to face relapse prevention intervention.
Behavioral: Tobacco Use Ban
Airmen are restricted from use tobacco products during Basic Military Training which lasts for 8.5 weeks.
Other Names:
  • Tobacco Ban
Behavioral: Tailored Pamphlet
A tailored relapse prevention pamphlet inspired by Forever Free and tailored for use in the United States Air Force.
Other Names:
  • Tailored tobacco cessation information
Behavioral: Relapse Prevention Intervention
A 15 - 30 minute relapse prevention intervention designed to increase motivation to remain tobacco free.
Other Names:
  • Relapse prevention
  • Motivational interventions
  • Brief interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking cessation maintenance
Time Frame: 12 month follow-up
Subjects will be called at one year post intervention to determine self-report of tobacco use status.
12 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delayed relapse among those who relapse to tobacco use
Time Frame: 12 month follow-up
Subjects will be contacted 12 months after the intervention to determine via self-report when they relapsed.
12 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
University of Minnesota
United States Air Force

Investigators

  • Principal Investigator: Robert C. Klesges, Ph.D., University of Tennessee Health Science Center and St. Jude Childrens' Research Hospital
  • Principal Investigator: Harry Lando, Ph.D., University of Minnesota
  • Principal Investigator: Gerald W. Talcott, Ph.D., University of Tennessee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

June 14, 2011

First Submitted That Met QC Criteria

June 15, 2011

First Posted (Estimate)

June 16, 2011

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH20100149H-2
  • 1R01HL095785-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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