An interventional study of Rate reduction intervention and Recycling Group in Initial Efficacy of Quit Line and Efficacy of Secondary Reengagement Intervention, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-26.
Sponsored by University of Virginia · Not applicable, Interventional, and Treatment
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.
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).
University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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Inclusion Criteria: To be included, individuals will be
Exclusion Criteria:
Rate reduction intervention
Behavioral: Rate reduction intervention · Behavioral: Proactive QL
Recycling Group
Behavioral: Recycling Group · Behavioral: Proactive QL
Choice Group
Behavioral: Choice Group · Behavioral: Proactive QL
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.
Time frame: From 3 months follow up to 1 year follow up
One-year outcome from the initially successful group that quit smoking
Time frame: 1-yr after initial randomization
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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