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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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).
- Conditions
- Smoking, Smoking Cessation
- 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 group | Role | What they receive |
|---|---|---|
| Ban & Informational Pamphlet | Experimental | Following 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 Pamphlet | 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 Receives: Behavioral: Tobacco Use Ban; Behavioral: Tailored Pamphlet |
| Ban & Tailored Pamphlet & Intervention | 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. 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.
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)
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.
- First posted16 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Minnesota, United States Air Force
- Responsible party
- Sponsor
- Investigators
- Robert C. Klesges, Ph.D., Principal investigator, University of Tennessee Health Science Center and St. Jude Childrens' Research HospitalHarry Lando, Ph.D., Principal investigator, University of MinnesotaGerald W. Talcott, Ph.D., Principal investigator, University of Tennessee
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Relapse Following Involuntary Smoking Abstinence
- ClinicalTrials.gov ID
- NCT01374724
- Acronym / sponsor ID
- AFV / FWH20100149H-2
- Conditions
- Smoking, Smoking Cessation
- Keywords
- Tobacco Use, Relapse Prevention, Military, Smokeless Tobacco Use, Dual Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23,000 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Minnesota, United States Air Force
- Study start
- May 2011
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 16 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ban & Informational Pamphlet | Experimental | Behavioral: Tobacco Use Ban, Behavioral: Informational PamphletFollowing 8.5 weeks of cessation subjects are given an informational pamphlet on tobacco cessation and relapse prevention. |
| Ban & Tailored Pamphlet | Experimental | Behavioral: Tobacco Use Ban, Behavioral: Tailored PamphletAfter 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 |
| Ban & Tailored Pamphlet & Intervention | Experimental | Behavioral: Tobacco Use Ban, Behavioral: Tailored Pamphlet, Behavioral: Relapse Prevention InterventionAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Active duty Air Force personnel
- Has smoked five or more cigarettes per day for at least 1 year before study entry
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco Use BanAlso: Tobacco BanAirmen are restricted from use tobacco products during Basic Military Training which lasts for 8.5 weeks. | Behavioural | Ban & Informational Pamphlet, Ban & Tailored Pamphlet, Ban & Tailored Pamphlet & Intervention |
| Tailored PamphletAlso: Tailored tobacco cessation informationA tailored relapse prevention pamphlet inspired by Forever Free and tailored for use in the United States Air Force. | Behavioural | Ban & Tailored Pamphlet, Ban & Tailored Pamphlet & Intervention |
| Informational PamphletAlso: Tobacco cessation pamphletsThe National Cancer Institute Pamphlet "Clearing the Air" was provided to subjects. | Behavioural | Ban & Informational Pamphlet |
| Relapse Prevention InterventionAlso: Relapse prevention, Motivational interventions, Brief interventionsA 15 - 30 minute relapse prevention intervention designed to increase motivation to remain tobacco free. | Behavioural | Ban & Tailored Pamphlet & Intervention |
Primary outcome
Smoking cessation maintenance
Time frame: 12 month follow-up
Subjects will be called at one year post intervention to determine self-report of tobacco use status.
1 secondary outcome
Delayed relapse among those who relapse to tobacco use
Time frame: 12 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Derived from this study: PubMed 24637237Brandon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert C. Klesges, Ph.D. principal investigator
University of Tennessee Health Science Center and St. Jude Childrens' Research Hospital
Harry Lando, Ph.D. principal investigator
University of Minnesota
Gerald W. Talcott, Ph.D. principal investigator
University of Tennessee
2 sites in 1 country: see every site and its status.
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.