Changing the Default for Tobacco Treatment

University of Kansas

Status and phase: Completed; Phase 4

Conditions: Tobacco Use Cessation

Treatments: Drug: Nicotine Replacement Therapy; Behavioral: Opt Out Treatment Program; Behavioral: Opt In Treatment Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02721082

R01HL131512 (U.S. NIH Grant/Contract)

STUDY00001774

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• Admission greater than 3 days

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Opt Out

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Replacement Therapy

Drug: Nicotine Replacement Therapy

Behavioral: Opt Out Treatment Program

Opt In

Active Comparator group

Description:

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.

Treatment:

Drug: Nicotine Replacement Therapy

Drug: Nicotine Replacement Therapy

Behavioral: Opt In Treatment Program