Precision Pharmacotherapy Smoking Cessation Program

Not Applicable

Completed

Interventions: Behavioral: Standard Care
Behavioral: Precision pharmacotherapy

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment Plan Option 1 (Standard Care)	Standard Care	Standard smoking cessation counseling will be offered + participant choice of nicotine patches or varenicline. Participants are also free to decline either medication.
Treatment Plan Option 2 (Precision Pharmacotherapy)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Achieve Smoking Cessation	4-week follow-up	Participants will report smoking status at the final assessment. Participants who self-report smoking cessation completed a carbon monoxide reading for biochemical confirmation of smoking status. The percentage of participants who achieve smoking cessation in each arm will be evaluated.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Reported Using Smoking Cessation Medication (4-week)	4-week follow-up	Participants will report whether smoking cessation medication was used during 4 week follow up. The percentage of participants who used medication in each arm will be evaluated.
Percentage of Participants Who Reported Using Smoking Cessation Medication (1-week)	1-week follow-up	Participants will report whether smoking cessation medication was used at the first week follow-up. The percentage of participants who used medication in each arm will be evaluated.
Percentage of Participants Who Reported Use of a Smoking Medication That Matched Their NMR Profile	1-week follow-up	Participants will report which smoking cessation medication, if any, was used. Medication usage will be classified as matching their NMR profile as follows: slower metabolizer = nicotine replacement therapy, faster metabolizer = varenicline. The percentage of participants who matched in each arm will be evaluated.