Preventing Relapse Following Involuntary Smoking Abstinence (AFV)
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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 |
- 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.
- 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: | 8000 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (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:
|
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 |
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| Contact: Phyllis A. Richey, Ph.D. | 901-448-5900 | prichey@uthsc.edu |
| Contact: Beate B. Griffin, RN, BS | 901-448-5900 | bgriffin@uthsc.edu |
| 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. | |
| 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
| Responsible Party: | Robert C. Klesges Ph.D./Principal Investigator, University of Tennessee Health Science Center and St. Jude Childrens' Research Hospital |
| ClinicalTrials.gov Identifier: | NCT01374724 History of Changes |
| Other Study ID Numbers: | FWH20100149H-2, 1R01HL095785-01A1 |
| Study First Received: | June 14, 2011 |
| Last Updated: | June 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Tennessee:
|
Tobacco Use Relapse Prevention Military Smokeless Tobacco Use Dual Use |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on May 22, 2013