Enhancing the Efficacy of Smoking Quit Line in the Military (AFIII Renewal)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2020-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a randomized clinical trial designed to measure the effectiveness of three QL interventions for smokers who failed to quit an initial smoking cessation intervention, but remain motivated to quit smoking.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00632411

Smoking Smoking Cessation

COMPLETED NA

Preventing Relapse Following Involuntary Smoking Abstinence

NCT01374724

Smoking Smoking Cessation

UNKNOWN NA

Evaluation of a Brief Tobacco Intervention in the US Military

NCT03196102

Tobacco Use Tobacco Smoking Smoking, Cigar +3 more

COMPLETED NA

Implementing Guidelines for Smoking Cessation: A Randomized Trial of Evidence-Based Quality Improvement

NCT00012987

Smoking Smoking Cessation Quality Improvement

COMPLETED NA

Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans

NCT00816036

Cigarette Smoking

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In the investigators' previous QL protocol, FWH20080093H, the investigators documented that a military-tailored QL was associated with high rates of sustained smoking cessation. The proactive QL produced superior cessation rates at a one year follow-up compared to a reactive QL. Unfortunately, even with high rates of cessation, a large number of participants (the majority of participants) fail to remain quit at follow-up. Civilian QLs have observed the same marked decay of sustained cessation rates from the end of treatment to the one year follow-up.

An opportunity exists to reengage these smokers who relapse or fail to quit by the end of QL treatment. Civilian QLs use one of two treatments, Recycling (repeat the smoking cessation counseling) or Rate Reduction (cut down over time), as the primary methods for treatment reengagement. Unfortunately, these methods of reengaging the relapsed/failed to quit smoker have not been systematically evaluated. As such, we propose to randomize participants who relapse or fail to quit by the end of the intervention to either (1) repeating the proactive QL (Recycle); (2) smoking reduction with the goal of eventual cessation (Rate Reduction); or (3) the choice of Recycle or Rate Reduction (Choice). Efficacy will be established by assessing both point prevalence and continuous abstinence at a 12 month follow-up.

All participants (approximately 1900) are consented to follow-up treatment reengagement since we do not know a priori who will quit and who will not quit/relapse. The investigators anticipate, based on the investigators' QL study that about 30% will quit and remain quit based on the eight-week proactive QL and about 70% will either not quit or relapse (n≈1300). Those that are smoking at the three-month follow-up are stratified (based on whether they quit and relapsed vs. not quitting at all in the Proactive QL based upon self-report) and randomized to the three treatment reengagement strategies (Recycle, Rate Reduction, or Choice), each one lasting 8 weeks. Then, at one year follow-up, the investigators will assess both point prevalence and continuous abstinence. Since we are intervening on those that initially failed to quit or relapsed, continuous abstinence will be defined from the point of the last treatment reengagement intervention (one year from that point).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Initial Efficacy of Quit Line Efficacy of Secondary Reengagement Intervention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2nd level intervention: Rate Reduction

Rate reduction intervention

Group Type EXPERIMENTAL

Rate reduction intervention

Intervention Type BEHAVIORAL

Proactive QL

Intervention Type BEHAVIORAL

2nd level intervention: Recycling

Recycling Group

Group Type EXPERIMENTAL

Recycling Group

Intervention Type BEHAVIORAL

Proactive QL

Intervention Type BEHAVIORAL

2nd level intervention: Choice

Choice Group

Group Type EXPERIMENTAL

Choice Group

Intervention Type BEHAVIORAL

Proactive QL

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rate reduction intervention

Intervention Type BEHAVIORAL

Recycling Group

Intervention Type BEHAVIORAL

Choice Group

Intervention Type BEHAVIORAL

Proactive QL

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Active Duty, Retired, or Dependent with Tricare benefits
* Participants must be at least 18 years old
* Smoked five or more cigarettes a day for at least one year
* Live in the 48 contiguous states, Alaska or Hawaii
* Participants must have the ability to understand consent procedures, and have access to a telephone for participation
* Seriously thinking of quitting smoking cigarettes in the next 30 days

Exclusion Criteria

* Persons who have a known or unknown knowledge of an allergy or hypersensitivity to Nicotine Replacement Therapy (NRT)
* Women who are pregnant, breastfeeding or planning to become pregnant during the next 12 months
* Persons diagnosed with an unstable heart condition will be excluded as NRT is contraindicated in these groups

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes