Clinical trial NCT00632411: Evaluating a Telephone-Based Smoking Cessation Program Among People in the Military (The AFIII Study)
Official title: Efficacy of a Smoking Quit Line in the Military
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Smoking Cessation
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-03-10
Enrollment: 1298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Continuous Abstinence
timeFrame: Measured at Year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Lackland Air Force Base
country: United States
facility: Wilford Hall Medical Center
state: Texas
Study officials:
affiliation: University of Tennessee Health Science Center and St. Jude Childrens' Research Hospital
name: Robert C. Klesges, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Harry Lando, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wilford Hall Medical Center; University of Tennessee Health Science Center
name: Gerald W. Talcott, Ph.D. Colonel (Ret.)
role: PRINCIPAL_INVESTIGATOR
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