Clinical trial NCT00632411
Conditions: Smoking Smoking Cessation
Sponsor: University of Tennessee
Start date: 2008-04-01; Completion date: 2014-07-01
Enrollment: 1298 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 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. arm 2: Participant will contact the research study staff to initiate the program.
Interventions: intervention 1: Nicotine Patch intervention 2: Tobacco Quit Line Program
Intervention descriptions: intervention 1: 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 2: 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.

Protocol documents: