Preventing Relapse Following Involuntary Smoking Abstinence

NCT01374724 | Unknown DMC

• 2 other identifiers: FWH20100149H-21R01HL095785-01A1
• Study Type: interventional
• Target: 23,000
• Locations: 1 country
• Sites: 2

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?

Conditions

Smoking; Smoking Cessation

Keywords

Tobacco Use; Relapse Prevention; Military; Smokeless Tobacco Use; Dual Use

Outcome Measures

Primary Outcomes (1)

• Smoking cessation maintenance

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

  12 month follow-up

Secondary Outcomes (1)

• Delayed relapse among those who relapse to tobacco use

  12 month follow-up

Study Arms (3)

Ban & Informational Pamphlet

EXPERIMENTAL

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

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

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.

Behavioral: Tobacco Use Ban; Behavioral: Tailored Pamphlet; Behavioral: Relapse Prevention Intervention

Interventions

Tobacco Use Ban BEHAVIORAL

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

Also known as: Tobacco Ban

Ban & Informational Pamphlet; Ban & Tailored Pamphlet; Ban & Tailored Pamphlet & Intervention

Tailored Pamphlet BEHAVIORAL

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

Also known as: Tailored tobacco cessation information

Ban & Tailored Pamphlet; Ban & Tailored Pamphlet & Intervention

Informational Pamphlet BEHAVIORAL

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

Also known as: Tobacco cessation pamphlets

Ban & Informational Pamphlet

Relapse Prevention Intervention BEHAVIORAL

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

Also known as: Relapse prevention, Motivational interventions, Brief interventions

Ban & Tailored Pamphlet & Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Tennessee: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Minnesota: collaborator
• United States Air Force: collaborator

Study Sites (2)

University of Tennessee Health Science Center

Memphis, Tennessee, 38105, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

Related Publications (1)

• 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.

  PMID: 24637237 DERIVED

MeSH Terms

Conditions

Smoking; Smoking Cessation; Tobacco Use

Interventions

Secondary Prevention; Crisis Intervention

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Robert C. Klesges, Ph.D.

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

  PRINCIPAL INVESTIGATOR

• Harry Lando, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Gerald W. Talcott, Ph.D.

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: June 16, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 1, 2016

Record last verified: 2015-11

Locations

US (2)