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Preventing Relapse Following Involuntary Smoking Abstinence (AFV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Tennessee
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
United States Air Force
Information provided by (Responsible Party):
Gerald W. Talcott, University of Tennessee
ClinicalTrials.gov Identifier:
NCT01374724
First received: June 14, 2011
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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?

Condition Intervention
Smoking
Smoking Cessation
Behavioral: Tobacco Use Ban
Behavioral: Tailored Pamphlet
Behavioral: Informational Pamphlet
Behavioral: Relapse Prevention Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preventing Relapse Following Involuntary Smoking Abstinence

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Smoking cessation maintenance [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]
    Subjects will be called at one year post intervention to determine self-report of tobacco use status.


Secondary Outcome Measures:
  • Delayed relapse among those who relapse to tobacco use [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]
    Subjects will be contacted 12 months after the intervention to determine via self-report when they relapsed.


Estimated Enrollment: 23000
Study Start Date: May 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Tobacco Ban
Behavioral: Informational Pamphlet
The National Cancer Institute Pamphlet "Clearing the Air" was provided to subjects.
Other Name: 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 Name: 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 Name: 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 Name: 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 Name: 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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Active duty Air Force personnel
  • Has smoked five or more cigarettes per day for at least 1 year before study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374724

Contacts
Contact: Phyllis A. Richey, Ph.D. 901-448-5900 prichey@uthsc.edu
Contact: Beate B. Griffin, RN, BS 901-448-5900 bgriffin@uthsc.edu

Locations
United States, Tennessee
University of Tennessee Health Science Center Recruiting
Memphis, Tennessee, United States, 38105
Contact: Phyllis R. Richey, Ph.D.    901-448-5900    prichey@uthsc.edu   
Contact: Karen LeRoy, R.N.    210-292-3504    kleroy1@uthsc.edu   
Principal Investigator: Robert C. Klesges, Ph.D.         
United States, Texas
Wilford Hall Medical Center Recruiting
Lackland AFB, Texas, United States, 78236
Contact: Karen LeRoy, Ph.D.    210-292-3504    kleroy1@uthsc.edu   
Principal Investigator: Gerald W. Talcott, Ph.D.         
Sponsors and Collaborators
Gerald W. Talcott
University of Minnesota - Clinical and Translational Science Institute
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 - Clinical and Translational Science Institute
Principal Investigator: Gerald W. Talcott, Ph.D. University of Tennessee Health Science Center
  More Information

No publications provided by University of Tennessee

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerald W. Talcott, Associate Professor, University of Tennessee
ClinicalTrials.gov Identifier: NCT01374724     History of Changes
Other Study ID Numbers: FWH20100149H-2, 1R01HL095785-01A1
Study First Received: June 14, 2011
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
Tobacco Use
Relapse Prevention
Military
Smokeless Tobacco Use
Dual Use

ClinicalTrials.gov processed this record on November 24, 2014