A Pilot Pragmatic RCT of a Hospital-based Precision Pharmacotherapy Smoking Cessation Program
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Smoking Cessation
- Sponsor
- Christiana Care Health Services
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Achieve Smoking Cessation
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Scott Siegel
Director of Population Health Research
Christiana Care Health Services
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
Outcomes
Primary Outcomes
Number of Participants Who Achieve Smoking Cessation
Time Frame: 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 Outcomes
- Percentage of Participants Who Reported Using Smoking Cessation Medication (4-week)(4-week follow-up)
- Percentage of Participants Who Reported Using Smoking Cessation Medication (1-week)(1-week follow-up)
- Percentage of Participants Who Reported Use of a Smoking Medication That Matched Their NMR Profile(1-week follow-up)