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Completed

NCT Number: NCT00632411

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tennessee Health Science Center, Memphis, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Continuous Abstinence

    Time frame: Measured at Year 1

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

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Efficacy of a Smoking Quit Line in the Military

Acronym: AFIII

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Mar 10, 2008
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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