Precision Pharmacotherapy Smoking Cessation Program

Christiana Care Health Services

Status: Completed

Conditions: Smoking Cessation

Treatments: Behavioral: Precision pharmacotherapy; Behavioral: Standard Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04897607

CCC# 41042 (Other Identifier)

DDD# 604572

U54GM104941 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Treatment Plan Option 1 (Standard Care)

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard Care

Treatment Plan Option 2 (Precision Pharmacotherapy)

Experimental group

Description:

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.

Treatment:

Behavioral: Precision pharmacotherapy