Smoking, Smoking Cessation
Conditions
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.
Interventions
DRUGNicotine 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.
BEHAVIORALTobacco 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Abstinence | Measured at Year 1 | No cigarette smoking since two weeks after the target quit date. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Proactive Group Research study staff will contact participant to initiate sessions.
8 weeks of Nicotine Replacement Therapy in the form of patch will be distributed this group.
Six sessions will be proactively delivered to the participant.
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.
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. | 649 |
| Reactive Group Participant will contact the research study staff to initiate sessions.
2 weeks of Nicotine Replacement Therapy in the form of patch will be distributed this group.
Six sessions will be delivered to the participant as long as the participant calls to initiate the sessions.
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.
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. | 649 |
| Total | 1,298 |
Baseline characteristics
| Characteristic | Proactive Group | Reactive Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 649 Participants | 649 Participants | 1298 Participants |
| Age, Continuous | 39.59 years STANDARD_DEVIATION 13.65 | 39.42 years STANDARD_DEVIATION 13.82 | 39.50 years STANDARD_DEVIATION 13.73 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 63 Participants | 61 Participants | 124 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 585 Participants | 588 Participants | 1173 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 10 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 85 Participants | 75 Participants | 160 Participants |
| Race (NIH/OMB) More than one race | 24 Participants | 24 Participants | 48 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 13 Participants | 5 Participants | 18 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants | 18 Participants | 39 Participants |
| Race (NIH/OMB) White | 493 Participants | 509 Participants | 1002 Participants |
| Region of Enrollment United States | 649 participants | 649 participants | 1298 participants |
| Sex: Female, Male Female | 291 Participants | 271 Participants | 562 Participants |
| Sex: Female, Male Male | 358 Participants | 378 Participants | 736 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 307 / 649 | 98 / 649 |
| serious Total, serious adverse events | 16 / 649 | 6 / 649 |
Outcome results
Primary
Continuous Abstinence
No cigarette smoking since two weeks after the target quit date.
Time frame: Measured at Year 1
Population: Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proactive Group | Continuous Abstinence | 173 Participants |
| Reactive Group | Continuous Abstinence | 136 Participants |