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

NCT ID: NCT00632411

Last Updated: 2018-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2014-07-31

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.

Detailed Description

Active duty military personnel are at high risk of cigarette smoking. Despite strong efforts by the Department of Defense to reduce tobacco use, rates of smoking among people in the military remain high. The military lifestyle presents unique challenges to implementing smoking cessation programs, including the high mobility of troops, remote locations, and limited access to healthcare services. Because of these challenges, many smoking cessation programs that are effective in the non-military population are often ineffective in the military population. Tobacco telephone quit lines are telephone-based tobacco cessation services that provide easy access to educational materials, referrals to local programs, and individualized telephone counseling. Because tobacco quit lines are remotely based and can fit into varying schedules at convenient times, they may be effective among people in the military. Nicotine replacement patches are another effective smoking cessation tool and can be used in addition to telephone quit lines. The purpose of this study is to evaluate the effectiveness of tobacco quit lines, in addition to nicotine replacement patches, at improving smoking cessation rates among members of the Air Force.

This study will enroll military healthcare beneficiaries who have smoked at least five cigarettes a day in the year before study entry. Participants will be randomly assigned to either a proactive group, in which study researchers will initiate contact with the participants, or a reactive group, in which participants will initiate contact with the researchers. In this six-session program, phone calls will occur at 1- to 2-week intervals over an 8-week period. The phone sessions will focus on cutting down on cigarette smoking, setting a quit date, and relapse prevention. All participants will receive nicotine replacement patches after the second session is completed. The reactive group will receive two weeks of nicotine replacement patches and the proactive group will receive 8 weeks of nicotine replacement patches. At the end of session four and 1 year later, study staff will call participants to collect information on tobacco abstinence, nicotine replacement patch use adherence, and other smoking cessation medication use.

Conditions

Smoking; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Proactive group

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.

Group Type: EXPERIMENTAL

Nicotine Patch

Intervention Type: 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.

Tobacco Quit Line Program

Intervention Type: 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.

Reactive group

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

Group Type: EXPERIMENTAL

Nicotine Patch

Intervention Type: 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.

Tobacco Quit Line Program

Intervention Type: 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.

Interventions

Nicotine Patch

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.

Intervention Type: DRUG

Tobacco Quit Line Program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Tennessee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert C. Klesges, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Harry Lando, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

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

Role: PRINCIPAL_INVESTIGATOR

Wilford Hall Medical Center; University of Tennessee Health Science Center

Locations

University of Tennessee Health Science Center

Memphis, Tennessee, United States

Wilford Hall Medical Center

Lackland Air Force Base, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12002168 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15010446 (View on PubMed)

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

Reference Type: 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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 15163928 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: 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)

Reference Type: 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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 15080246 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 2503780 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26226536 (View on PubMed)

Other Identifiers

R18HL053478-07A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

524

Identifier Type: -

Identifier Source: org_study_id