Preventing Relapse Following Involuntary Smoking Abstinence

Smoking Cessation Clinical Trial

— AFV  

Official title:

Preventing Relapse Following Involuntary Smoking Abstinence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01374724
• Other study ID #: FWH20100149H-2
• Secondary ID: 1R01HL095785-01A
• Status: Active, not recruiting
• Phase: N/A
• First received: June 14, 2011
• Last updated: October 31, 2016
• Start date: May 2011
• Est. completion date: August 2017

Study information

• Verified date: November 2015
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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?

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23000
• Est. completion date: August 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Active duty Air Force personnel

• Has smoked five or more cigarettes per day for at least 1 year before study entry

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Recurrence
• Smoking
• Smoking Cessation

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Wilford Hall Medical Center	Lackland AFB	Texas
United States	University of Tennessee Health Science Center	Memphis	Tennessee

Sponsors (4)

Lead Sponsor	Collaborator
University of Tennessee	National Heart, Lung, and Blood Institute (NHLBI), United States Air Force, University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking cessation maintenance	Subjects will be called at one year post intervention to determine self-report of tobacco use status.	12 month follow-up	No
Secondary	Delayed relapse among those who relapse to tobacco use	Subjects will be contacted 12 months after the intervention to determine via self-report when they relapsed.	12 month follow-up	No