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

Not Applicable

Completed

Conditions: Smoking Cessation
Smoking

Interventions: Drug: Nicotine Patch
Behavioral: Tobacco Quit Line Program

Registration Number: NCT00632411

Lead Sponsor: University of Tennessee

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1298

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proactive group	Nicotine Patch	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.
Reactive group	Nicotine Patch	Participant will contact the research study staff to initiate the program.
Reactive group	Tobacco Quit Line Program	Participant will contact the research study staff to initiate the program.
Proactive group	Tobacco Quit Line Program	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.

Primary Outcome Measures

Name	Time	Method
Continuous Abstinence	Measured at Year 1	No cigarette smoking since two weeks after the target quit date.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (2): Wilford Hall Medical Center
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Lackland Air Force Base, Texas, United States
University of Tennessee Health Science Center
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Memphis, Tennessee, United States