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

Enhancing the Efficacy of Smoking Quit Line in the Military

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.

Study Overview

• Status: Completed
• Conditions: Initial Efficacy of Quit Line; Efficacy of Secondary Reengagement Intervention
• Intervention / Treatment: Behavioral: Rate reduction intervention; Behavioral: Proactive QL; Behavioral: Recycling Group; Behavioral: Choice Group

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 614
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lackland Air Force Base, Texas, United States, 78236
      • Wilford Hall Ambulatory Surgical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria: To be included, individuals will be

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2nd level intervention: Rate Reduction; Rate reduction intervention	Behavioral: Rate reduction intervention; Behavioral: Proactive QL
Experimental: 2nd level intervention: Recycling; Recycling Group	Behavioral: Proactive QL; Behavioral: Recycling Group
Experimental: 2nd level intervention: Choice; Choice Group	Behavioral: Proactive QL; Behavioral: Choice Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of randomized reengagement interventions	We will assess tobacco status (both 7-day point prevalence and continuous abstinence) at the follow-up period (one year after reengagement interventions are completed) to assess outcome.	From 3 months follow up to 1 year follow up

Secondary Outcome Measures

Outcome Measure	Time Frame
One-year outcome from the initially successful group that quit smoking	1-yr after initial randomization

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: University of Tennessee
• Investigators: Principal Investigator: Robert Klesges, PhD, UTHSC; Principal Investigator: Wayne Talcott, PhD, UTHSC

Publications and helpful links

General Publications

• Little MA, Ebbert JO, Bursac Z, Talcott GW, Talley L, LeRoy KM, Womack CR, Hryshko-Mullen AS, Klesges RC. Enhancing the efficacy of a smoking quit line in the military: Study rationale, design and methods of the Freedom quit line. Contemp Clin Trials. 2017 Aug;59:51-56. doi: 10.1016/j.cct.2017.04.011. Epub 2017 May 4. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: July 24, 2014
• First Submitted That Met QC Criteria: July 25, 2014
• First Posted (Estimate): July 28, 2014

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: smoking cessation; nicotine replacement therapy; quit line; tobacco intervention
• Other Study ID Numbers: FWH20140076H