Overview

This trial is active, not recruiting.

Conditions smoking, smoking cessation
Treatments tobacco use ban, tailored pamphlet, informational pamphlet, relapse prevention intervention
Sponsor University of Tennessee
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date May 2011
End date April 2017
Trial size 23000 participants
Trial identifier NCT01374724, 1R01HL095785-01A1, FWH20100149H-2

Summary

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?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Following 8.5 weeks of cessation subjects are given an informational pamphlet on tobacco cessation and relapse prevention.
tobacco use ban Tobacco Ban
Airmen are restricted from use tobacco products during Basic Military Training which lasts for 8.5 weeks.
informational pamphlet Tobacco cessation pamphlets
The National Cancer Institute Pamphlet "Clearing the Air" was provided to subjects.
(Experimental)
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 Tobacco Ban
Airmen are restricted from use tobacco products during Basic Military Training which lasts for 8.5 weeks.
tailored pamphlet Tailored tobacco cessation information
A tailored relapse prevention pamphlet inspired by Forever Free and tailored for use in the United States Air Force.
(Experimental)
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 Tobacco Ban
Airmen are restricted from use tobacco products during Basic Military Training which lasts for 8.5 weeks.
tailored pamphlet Tailored tobacco cessation information
A tailored relapse prevention pamphlet inspired by Forever Free and tailored for use in the United States Air Force.
relapse prevention intervention Relapse prevention
A 15 - 30 minute relapse prevention intervention designed to increase motivation to remain tobacco free.

Primary Outcomes

Measure
Smoking cessation maintenance
time frame: 12 month follow-up

Secondary Outcomes

Measure
Delayed relapse among those who relapse to tobacco use
time frame: 12 month follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Preventing Relapse Following Involuntary Smoking Abstinence
Principal investigator Robert C. Klesges, Ph.D.
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).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Tennessee.