Clinical trial NCT02201810: Enhancing the Efficacy of Smoking Quit Line in the Military (AFIII Renewal)
Official title: Enhancing the Efficacy of Smoking Quit Line in the Military
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Initial Efficacy of Quit Line
Efficacy of Secondary Reengagement Intervention
Keywords: smoking cessation
quit line
nicotine replacement therapy
tobacco intervention
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: University of Tennessee
First posted: 2014-07-28
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of randomized reengagement interventions
timeFrame: From 3 months follow up to 1 year follow up
Secondary outcomes:
measure: One-year outcome from the initially successful group that quit smoking
timeFrame: 1-yr after initial randomization
Other outcomes:
Locations:
city: Lackland Air Force Base
country: United States
facility: Wilford Hall Ambulatory Surgical Center
state: Texas
Study officials:
affiliation: UTHSC
name: Robert Klesges, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UTHSC
name: Wayne Talcott, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.