Changing the Default for Tobacco Treatment

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2020-12-09

Brief Summary

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

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Detailed Description

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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

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Tobacco Use Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Opt Out

Participants in this arm will be first enrolled to receive cessation treatment and will only not receive it by "opting out". Participant will receive a Opt Out treatment program. Participants will receive counseling and nicotine replacement therapy.

Group Type EXPERIMENTAL

Opt Out Treatment Program

Intervention Type BEHAVIORAL

Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.

Nicotine Replacement Therapy

Intervention Type DRUG

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.

Opt In

Traditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program.

Group Type ACTIVE_COMPARATOR

Opt In Treatment Program

Intervention Type BEHAVIORAL

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.

Nicotine Replacement Therapy

Intervention Type DRUG

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.

Interventions

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Opt Out Treatment Program

Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.

Intervention Type BEHAVIORAL

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.

Intervention Type DRUG

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.

Intervention Type BEHAVIORAL

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.

Intervention Type DRUG

Other Intervention Names

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Nicotine patch Nicotine mini-lozenges Nicotine gum Nicotine patch Nicotine mini-lozenges Nicotine gum

Eligibility Criteria

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Inclusion Criteria

* Speak English or Spanish
* Have access to a telephone or mobile phone
* Not be currently pregnant or breast feeding
* Have no significant co-morbidity that precludes participation
* Current daily smoker
* Not in treatment for tobacco dependence
* Reside in Kansas or Missouri