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Preventing Relapse Following Involuntary Smoking Abstinence (AFV)

Primary Purpose

Smoking, Smoking Cessation

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tobacco Use Ban
Tailored Pamphlet
Informational Pamphlet
Relapse Prevention Intervention
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking focused on measuring Tobacco Use, Relapse Prevention, Military, Smokeless Tobacco Use, Dual Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • University of Tennessee Health Science Center
  • Wilford Hall Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Ban & Informational Pamphlet

Ban & Tailored Pamphlet

Ban & Tailored Pamphlet & Intervention

Arm Description

Following 8.5 weeks of cessation subjects are given an informational pamphlet on tobacco cessation and relapse prevention.

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 14, 2011
Last Updated
October 31, 2016
Sponsor
University of Tennessee
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of Minnesota, United States Air Force
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1. Study Identification

Unique Protocol Identification Number
NCT01374724
Brief Title
Preventing Relapse Following Involuntary Smoking Abstinence
Acronym
AFV
Official Title
Preventing Relapse Following Involuntary Smoking Abstinence
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of Minnesota, United States Air Force

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Smoking Cessation
Keywords
Tobacco Use, Relapse Prevention, Military, Smokeless Tobacco Use, Dual Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ban & Informational Pamphlet
Arm Type
Experimental
Arm Description
Following 8.5 weeks of cessation subjects are given an informational pamphlet on tobacco cessation and relapse prevention.
Arm Title
Ban & Tailored Pamphlet
Arm Type
Experimental
Arm Description
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
Arm Title
Ban & Tailored Pamphlet & Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tobacco Use Ban
Other Intervention Name(s)
Tobacco Ban
Intervention Description
Airmen are restricted from use tobacco products during Basic Military Training which lasts for 8.5 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Tailored Pamphlet
Other Intervention Name(s)
Tailored tobacco cessation information
Intervention Description
A tailored relapse prevention pamphlet inspired by Forever Free and tailored for use in the United States Air Force.
Intervention Type
Behavioral
Intervention Name(s)
Informational Pamphlet
Other Intervention Name(s)
Tobacco cessation pamphlets
Intervention Description
The National Cancer Institute Pamphlet "Clearing the Air" was provided to subjects.
Intervention Type
Behavioral
Intervention Name(s)
Relapse Prevention Intervention
Other Intervention Name(s)
Relapse prevention, Motivational interventions, Brief interventions
Intervention Description
A 15 - 30 minute relapse prevention intervention designed to increase motivation to remain tobacco free.
Primary Outcome Measure Information:
Title
Smoking cessation maintenance
Description
Subjects will be called at one year post intervention to determine self-report of tobacco use status.
Time Frame
12 month follow-up
Secondary Outcome Measure Information:
Title
Delayed relapse among those who relapse to tobacco use
Description
Subjects will be contacted 12 months after the intervention to determine via self-report when they relapsed.
Time Frame
12 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert C. Klesges, Ph.D.
Organizational Affiliation
University of Tennessee Health Science Center and St. Jude Childrens' Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harry Lando, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerald W. Talcott, Ph.D.
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Wilford Hall Medical Center
City
Lackland AFB
State/Province
Texas
ZIP/Postal Code
78236
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24637237
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.
Results Reference
derived

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Preventing Relapse Following Involuntary Smoking Abstinence

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