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

What Was Tested

In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

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.

It had two arms (groups): Proactive group (experimental) and Reactive group (experimental).

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.

Participant will contact the research study staff to initiate the program.

The registry classes the interventions as behavioral and drug.

More on the Plan

Active duty military personnel are at high risk of cigarette smoking.

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.

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.

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.

Who Took Part

Enrollment: 1298 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Has smoked five or more cigarettes per day for at least 1 year before study entry. Must be at least eighteen years old.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: known allergy or sensitivity to nicotine replacement therapy; no telephone; inability to understand consent procedures.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2008-04 with completion listed for 2014-07.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Continuous Abstinence (time frame: Measured at Year 1).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 1298 people.

With 1298 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.