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Preventing Relapse Following Involuntary Smoking Abstinence


N/A
18 Years
N/A
Open (Enrolling)
Both
Smoking, Smoking Cessation

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Trial Information

Preventing Relapse Following Involuntary Smoking Abstinence


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).


Inclusion Criteria:



- Active duty Air Force personnel

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Smoking cessation maintenance

Outcome Description:

Subjects will be called at one year post intervention to determine self-report of tobacco use status.

Outcome Time Frame:

12 month follow-up

Safety Issue:

No

Principal Investigator

Robert C. Klesges, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Tennessee Health Science Center and St. Jude Childrens' Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

FWH20100149H-2

NCT ID:

NCT01374724

Start Date:

May 2011

Completion Date:

January 2015

Related Keywords:

  • Smoking
  • Smoking Cessation
  • Tobacco Use
  • Relapse Prevention
  • Military
  • Smokeless Tobacco Use
  • Dual Use
  • Smoking

Name

Location

Wilford Hall Medical Center Lackland Air Force Base, Texas  78236-5300
University of Tennessee Health Science Center Memphis, Tennessee  38105