Precision Pharmacotherapy Smoking Cessation Program

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-23

Study Completion Date

2022-12-31

Brief Summary

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The purpose of this study is to determine the benefits of a personalized treatment approach, compared to a non-personalized treatment approach, for smoking cessation. In other words, this study will help us know if recommending a specific medication to individual smokers will make it easier to quit smoking than simply offering an option of medications. The specific recommendation for a medication will be based on a test that measures how quickly a smoker breaks down, or metabolizes, nicotine.

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Detailed Description

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Promising new evidence suggests that applying a precision pharmacotherapy approach based on the nicotine metabolite ration (NMR), a commercially available, genetically-informed marker of nicotine metabolism rate can significantly improve cessation outcomes. Evidence from multiple independent studies, including a recent randomized clinical trial (RCT), demonstrates that matching slow metabolizers of nicotine with the nicotine patch and fast metabolizers of nicotine with varenicline can maximize treatment response and minimize side effects. While encouraging, a critical gap in knowledge is how to best translate a precision pharmacotherapy approach into a hospital-based smoking cessation intervention and improve cessation rates for underserved smokers. Preliminary data suggest that personalized treatment recommendations may increase smoking cessation medication uptake and effectiveness. Thus, the scientific premise of this application is that integrating a precision pharmacotherapy approach into a hospital-based smoking cessation program will increase medication uptake and effectiveness, with particular relevance for smokers from underserved communities.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized to the precision or standard care arms in a 1:1 ratio

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Plan Option 1 (Standard Care)

Standard smoking cessation counseling will be offered + participant choice of nicotine patches or varenicline. Participants are also free to decline either medication.

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

Participants will be advised to quit smoking and offered a choice of nicotine replacement patches or varenicline. Participants are free to decline medication.

Treatment Plan Option 2 (Precision Pharmacotherapy)

Standard smoking cessation counseling will be offered + a recommendation to take either the nicotine patch or varenicline based on the results of the NMR test. Regardless of the recommendation, it would still remain the participant's choice to be prescribed either nicotine patches or varenicline. Participants are also free to decline either medication.

Group Type EXPERIMENTAL

Precision pharmacotherapy

Intervention Type BEHAVIORAL

Participants will be advised to quit smoking and provided a medication recommendation on the basis of their nicotine metabolite ratio (NMR) test (i.e., nicotine replacement patches for slower metabolizers, varenicline for faster metabolizers). Participants are free to choose either medication or decline any medication.

Interventions

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Standard Care

Participants will be advised to quit smoking and offered a choice of nicotine replacement patches or varenicline. Participants are free to decline medication.

Intervention Type BEHAVIORAL

Precision pharmacotherapy

Participants will be advised to quit smoking and provided a medication recommendation on the basis of their nicotine metabolite ratio (NMR) test (i.e., nicotine replacement patches for slower metabolizers, varenicline for faster metabolizers). Participants are free to choose either medication or decline any medication.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* current smoker (5+ cigarettes/day)
* patient at the Helen F. Graham Cancer Center \& Research Institute (ChristianaCare) lung/thoracic clinic

Exclusion Criteria

* use of non-cigarette tobacco products or smoking cessation treatment
* psychiatric or other medical contraindications to receiving smoking cessation medication
* no telephone
* medical instability
* inability to communicate in English
* unable to consent due to mental status
* estimated life expectancy of \<6 months
* not a Delaware resident
* pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes