Clinical trial NCT01374724: Preventing Relapse Following Involuntary Smoking Abstinence
Official title: Preventing Relapse Following Involuntary Smoking Abstinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking
Smoking Cessation
Keywords: Tobacco Use
Relapse Prevention
Military
Smokeless Tobacco Use
Dual Use
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Minnesota
name: United States Air Force
First posted: 2011-06-16
Enrollment: 23000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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?

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 criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Smoking cessation maintenance
timeFrame: 12 month follow-up
Secondary outcomes:
measure: Delayed relapse among those who relapse to tobacco use
timeFrame: 12 month follow-up
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Lackland AFB
country: United States
facility: Wilford Hall Medical Center
state: Texas
Study officials:
affiliation: University of Tennessee Health Science Center and St. Jude Childrens' Research Hospital
name: Robert C. Klesges, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Harry Lando, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee
name: Gerald W. Talcott, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.