Clinical trial NCT04897607: Precision Pharmacotherapy Smoking Cessation Program
Official title: A Pilot Pragmatic RCT of a Hospital-based Precision Pharmacotherapy Smoking Cessation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: University of Delaware
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2021-05-21
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to the precision or standard care arms in a 1:1 ratio
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Achieve Smoking Cessation
timeFrame: 4-week follow-up
Secondary outcomes:
measure: Percentage of Participants Who Reported Using Smoking Cessation Medication (1-week)
timeFrame: 1-week follow-up
measure: Percentage of Participants Who Reported Using Smoking Cessation Medication (4-week)
timeFrame: 4-week follow-up
measure: Percentage of Participants Who Reported Use of a Smoking Medication That Matched Their NMR Profile
timeFrame: 1-week follow-up
Other outcomes:
Locations:
city: Newark
country: United States
facility: Helen F. Graham Cancer Center & Research Institute
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Scott D Siegel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: