Preventing Relapse Following Involuntary Smoking Abstinence
NCT ID: NCT01374724
Last Updated: 2016-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
23000 participants
INTERVENTIONAL
2011-05-31
2017-08-31
Brief Summary
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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?
Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Ban & Informational Pamphlet
Following 8.5 weeks of cessation subjects are given an informational pamphlet on tobacco cessation and relapse prevention.
Tobacco Use Ban
Airmen are restricted from use tobacco products during Basic Military Training which lasts for 8.5 weeks.
Informational Pamphlet
The National Cancer Institute Pamphlet "Clearing the Air" was provided to subjects.
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
Tobacco Use Ban
Airmen are restricted from use tobacco products during Basic Military Training which lasts for 8.5 weeks.
Tailored Pamphlet
A tailored relapse prevention pamphlet inspired by Forever Free and tailored for use in the United States Air Force.
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.
Tobacco Use Ban
Airmen are restricted from use tobacco products during Basic Military Training which lasts for 8.5 weeks.
Tailored Pamphlet
A tailored relapse prevention pamphlet inspired by Forever Free and tailored for use in the United States Air Force.
Relapse Prevention Intervention
A 15 - 30 minute relapse prevention intervention designed to increase motivation to remain tobacco free.
Interventions
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Tobacco Use Ban
Airmen are restricted from use tobacco products during Basic Military Training which lasts for 8.5 weeks.
Tailored Pamphlet
A tailored relapse prevention pamphlet inspired by Forever Free and tailored for use in the United States Air Force.
Informational Pamphlet
The National Cancer Institute Pamphlet "Clearing the Air" was provided to subjects.
Relapse Prevention Intervention
A 15 - 30 minute relapse prevention intervention designed to increase motivation to remain tobacco free.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has smoked five or more cigarettes per day for at least 1 year before study entry
18 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Minnesota
OTHER
United States Air Force
FED
University of Tennessee
OTHER
Responsible Party
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Principal Investigators
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Robert C. Klesges, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee Health Science Center and St. Jude Childrens' Research Hospital
Harry Lando, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Gerald W. Talcott, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Locations
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University of Tennessee Health Science Center
Memphis, Tennessee, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
Countries
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References
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Brandon TH, Klesges RC, Ebbert JO, Talcott GW, Thomas F, Leroy K, Richey PA, Colvin L. Preventing smoking initiation or relapse following 8.5 weeks of involuntary smoking abstinence in basic military training: trial design, interventions, and baseline data. Contemp Clin Trials. 2014 May;38(1):28-36. doi: 10.1016/j.cct.2014.03.001. Epub 2014 Mar 15.
Other Identifiers
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FWH20100149H-2
Identifier Type: -
Identifier Source: org_study_id