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Completed

NCT Number: NCT04897607

Precision Pharmacotherapy Smoking Cessation Program

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helen F. Graham Cancer Center & Research Institute

Newark, Delaware, 19713, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Care

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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

  1. Percentage of Participants Who Reported Using Smoking Cessation Medication (1-week)

    Time frame: 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.

  2. Percentage of Participants Who Reported Using Smoking Cessation Medication (4-week)

    Time frame: 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.

  3. Percentage of Participants Who Reported Use of a Smoking Medication That Matched Their NMR Profile

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)
  • University of Delaware

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 21, 2021
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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