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SmokingAFVNCT01374724

Preventing Relapse Following Involuntary Smoking Abstinence

A study testing Tobacco Use Ban, Tailored Pamphlet and Informational Pamphlet in people with Smoking and Smoking Cessation, run by University of Tennessee at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking, Smoking Cessation
What is being tested?
Tobacco Use Ban, Tailored Pamphlet and Informational Pamphlet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23,000 participants
Where
2 sitesUnited States
Study dates
May 2011to Aug 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38105

Other trials in United States

About this study

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?
Read the 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).

Being tested
Tobacco Use Ban, Tailored Pamphlet, Informational Pamphlet, Relapse Prevention Intervention
Keywords
Tobacco Use, Relapse Prevention, Military, Smokeless Tobacco Use, Dual Use
Medical subject headings
Smoking, Smoking Cessation, Tobacco Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tobacco Use BanBehavioural

    Also called Tobacco Ban

    Airmen are restricted from use tobacco products during Basic Military Training which lasts for 8.5 weeks.

  • Tailored PamphletBehavioural

    Also called Tailored tobacco cessation information

    A tailored relapse prevention pamphlet inspired by Forever Free and tailored for use in the United States Air Force.

  • Informational PamphletBehavioural

    Also called Tobacco cessation pamphlets

    The National Cancer Institute Pamphlet "Clearing the Air" was provided to subjects.

  • Relapse Prevention InterventionBehavioural

    Also called Relapse prevention, Motivational interventions, Brief interventions

    A 15 - 30 minute relapse prevention intervention designed to increase motivation to remain tobacco free.

Study groups in NCT01374724
Study groupRoleWhat they receive
Ban & Informational PamphletExperimentalFollowing 8.5 weeks of cessation subjects are given an informational pamphlet on tobacco cessation and relapse prevention.
Receives: Behavioral: Tobacco Use Ban; Behavioral: Informational Pamphlet
Ban & Tailored PamphletExperimentalAfter 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
Receives: Behavioral: Tobacco Use Ban; Behavioral: Tailored Pamphlet
Ban & Tailored Pamphlet & InterventionExperimentalAfter 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.
Receives: Behavioral: Tobacco Use Ban; Behavioral: Tailored Pamphlet; Behavioral: Relapse Prevention Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Smoking cessation maintenance

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

    Measured: 12 month follow-up

Secondary outcomes (1)
  1. 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.

    Measured: 12 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionApr 2017 (estimated)
  4. Study completionAug 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
23,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01374724
Sponsor's protocol ID
FWH20100149H-2
Other IDs
1R01HL095785-01A1
Acronym
AFV
Status last verified
Nov 2015
First submitted
14 Jun 2011
Last updated
1 Nov 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24637237

Questions about this trial

What is this clinical trial studying?

A study testing Tobacco Use Ban, Tailored Pamphlet and Informational Pamphlet in people with Smoking and Smoking Cessation, run by University of Tennessee at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking cessation maintenance (time frame: 12 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01374724, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.

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