NCT02721082

Changing the Default for Tobacco Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the impact and efficacy of a new approach to smoking cessation treatment versus the traditional approach.

Detailed description

In many health conditions, the default treatment approach is to first identify the health condition and then begin treatment. In this scenario, the physician discusses treatment options with the patient. The patient is free to decline treatment as they wish. If patients do nothing though, they will receive care. For tobacco users, the default treatment is for them to "opt in" to receive smoking cessation assistance. The provider asks the smoker if they are ready to quit, and they offer medication and support only to those who respond back "yes". This limits the amount of smokers that receive treatment because only 1 in 3 smokers say they are ready to quit. This study is looking at a novel approach to smoking cessation treatment. This study will compare the traditional, "standard of care" approach to opting in against a new approach where all smokers are provided with cessation medication and counseling unless they refuse it.

Conditions

• Tobacco Use Cessation

Interventions

Type	Name	Description
BEHAVIORAL	Opt Out Treatment Program	Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
DRUG	Nicotine Replacement Therapy	Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
BEHAVIORAL	Opt In Treatment Program	Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.
DRUG	Nicotine Replacement Therapy	Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.

Timeline

• Start date: 2016-09-01
• Primary completion: 2020-07-27
• Completion: 2020-12-09
• First posted: 2016-03-28
• Last updated: 2022-12-01
• Results posted: 2022-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study