Precision Pharmacotherapy Smoking Cessation Program

Smoking Cessation Clinical Trial

Official title:

A Pilot Pragmatic RCT of a Hospital-based Precision Pharmacotherapy Smoking Cessation Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04897607
• Other study ID #: DDD# 604572
• Secondary ID: U54GM104941CCC#
• Status: Completed
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Helen F. Graham Cancer Center & Research Institute	Newark	Delaware

Sponsors (3)

Lead Sponsor	Collaborator
Christiana Care Health Services	National Institute of General Medical Sciences (NIGMS), University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Achieve Smoking Cessation	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.	4-week follow-up
Secondary	Percentage of Participants Who Reported Using Smoking Cessation Medication (1-week)	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.	1-week follow-up
Secondary	Percentage of Participants Who Reported Using Smoking Cessation Medication (4-week)	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.	4-week follow-up
Secondary	Percentage of Participants Who Reported Use of a Smoking Medication That Matched Their NMR Profile	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.	1-week follow-up