Evaluating a Telephone-Based Smoking Cessation Program Among People in the Military (The AFIII Study)

NCT00632411 | Completed Results DMC

• 2 other identifiers: 524R18HL053478-07A2
• Study Type: interventional
• Target: 1,298
• Locations: 1 country
• Sites: 2

Brief Summary

Rates of cigarette smoking in the military are high. Tobacco telephone quit lines are telephone-based services that provide information and guidance to people who want to quit smoking. This study will evaluate the effectiveness of a tobacco quit line program, in addition to nicotine replacement patches, at helping people in the military quit smoking cigarettes.

Conditions

Smoking; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Continuous Abstinence

  No cigarette smoking since two weeks after the target quit date.

  Measured at Year 1

Study Arms (2)

Proactive group

EXPERIMENTAL

Research study staff will contact participant to initiate the program. Half of participants will be randomized to the proactive condition and the other half to the reactive conditions.

Drug: Nicotine Patch; Behavioral: Tobacco Quit Line Program

Reactive group

EXPERIMENTAL

Participant will contact the research study staff to initiate the program.

Drug: Nicotine Patch; Behavioral: Tobacco Quit Line Program

Interventions

Nicotine Patch DRUG

Participants who smoke more than 20 cigarettes per day will use a 21-mg patch for 4 weeks, a 14-mg patch for the next 2 weeks, a 7-mg patch for the next 2 weeks, and then no patch. Participants who smoke between 10 to 19 cigarettes per day will use a 14-mg patch for 4 weeks, a 7-mg patch for the next 4 weeks, and then no patch. Participants who smoke between 5 to 9 cigarettes per day will use a 7-mg patch for 8 weeks and then no patch. The proactive group will be given 8 weeks of patch treatment and the reactive group will be given 2 weeks of patch treatment.

Proactive group; Reactive group

Tobacco Quit Line Program BEHAVIORAL

Phone session 1 will focus on smoking reduction. Phone session 2 will focus on preparing to quit and surviving the first days as a non-smoker. A quit date will be set in 7 to 10 days. Nicotine patches will be sent to participant with detailed instructions for patch use. Phone session 3 will focus on the first days after the quit date. Phone session 4 will focus on a review of progress and challenges of quitting. Plans to manage high-risk situations will be discussed. Phone session 5 will focus on short-term relapse prevention. Phone session 6 will focus on long-term relapse prevention.

Proactive group; Reactive group

Eligibility Criteria

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

You may qualify if:

• Department of Defense healthcare beneficiary
• Has smoked five or more cigarettes per day for at least 1 year before study entry
• Must be at least eighteen years old

You may not qualify if:

• Known allergy or sensitivity to nicotine replacement therapy
• No telephone
• Inability to understand consent procedures
• Basic Military Trainee

Sponsors & Collaborators

• University of Tennessee: lead
• National Heart, Lung, and Blood Institute (NHLBI): 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 (12)

• Centers for Disease Control and Prevention (CDC). Annual smoking-attributable mortality, years of potential life lost, and economic costs--United States, 1995-1999. MMWR Morb Mortal Wkly Rep. 2002 Apr 12;51(14):300-3.

  PMID: 12002168 BACKGROUND

• Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004 Mar 10;291(10):1238-45. doi: 10.1001/jama.291.10.1238.

  PMID: 15010446 BACKGROUND

• Bray RM, Hourani LL, Rae KL, al. e: Department of Defense Survey of Health Related Behaviors Among Military Personnel, in Report No. RTI/7841/006-FR, Research Triangle Park, NC, RTI International, 2003

  BACKGROUND

• U.S. Department of Health and Human Services: The health consequences of smoking; a report of the surgeon general., in, Atlanta, GA, USDHHS, Centers for Disease Control and Prevention, National Center for Chronic Disease and Prevention and Health Promotion, Office on Smoking and Health, 2004

  BACKGROUND

• Centers for Disease Control and Prevention (CDC). Cigarette smoking among adults--United States, 2002. MMWR Morb Mortal Wkly Rep. 2004 May 28;53(20):427-31.

  PMID: 15163928 BACKGROUND

• Department of Defense: Tobacco use prevention strategic plan., in, Washington, D.C., Department of Defense, 1999

  BACKGROUND

• Department of Defense: Smoking in DoD occupied buildings and facilities., in, Washington, DC, Department of Defense, 1977, p Instruction No. 6015.6018

  BACKGROUND

• Department of Defense: Health promotion., in, Washington, D.C., Department of Defense, 1994b, pp Directive No. 1010.1010 (1010.1010 supersedes and cancels March 1011, 1986, version of Directive No. 1010.1010)

  BACKGROUND

• Department of Defense: DoD food and nutrition research, development, testing, evaluation, and engineering program., in, Washington, D.C., Department of Defense, 1983, p Instruction No. 3235.3232

  BACKGROUND

• Conway TL, Woodruff SI, Edwards CC, Elder JP, Hurtado SL, Hervig LK. Operation Stay Quit: evaluation of two smoking relapse prevention strategies for women after involuntary cessation during US Navy recruit training. Mil Med. 2004 Mar;169(3):236-42. doi: 10.7205/milmed.169.3.236.

  PMID: 15080246 BACKGROUND

• Cronan TA, Conway TL, Hervig LK. Evaluation of smoking interventions in recruit training. Mil Med. 1989 Jul;154(7):371-5.

  PMID: 2503780 BACKGROUND

• Klesges RC, Ebbert JO, Talcott GW, Thomas F, Richey PA, Womack C, Hryshko-Mullen A, Oh J. Efficacy of a Tobacco Quitline in Active Duty Military and TRICARE Beneficiaries: A Randomized Trial. Mil Med. 2015 Aug;180(8):917-25. doi: 10.7205/MILMED-D-14-00513.

  PMID: 26226536 DERIVED

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Robert Klesges
• Organization: University of Tennessee Health Science Center

lcolvin1@uthsc.edu

901-448-3174

Study Officials

• Robert C. Klesges, PhD

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

  PRINCIPAL INVESTIGATOR

• Harry Lando, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Gerald W. Talcott, Ph.D. Colonel (Ret.)

  Wilford Hall Medical Center; University of Tennessee Health Science Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 10, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 14, 2018
• Results First Posted: May 24, 2017

Record last verified: 2016-09

Locations

US (2)