Skip to main content
OpenTrials
Completed

NCT Number: NCT03227679

Metabolism-informed Care for Smoking Cessation

Nicotine mediates smoking's addictive effects in the brain. The ratio of 3-hydroxycotinine to cotinine, known as the nicotine metabolite ratio, or NMR, is a genetically- informed biomarker reflecting hepatic CYP2A6 activity and the rate of nicotine metabolism. In light of a recent randomized controlled trial (RCT) in humans in Lancet Respiratory Medicine, which found that the NMR can be used to individualize treatment for smokers, our pilot study aims to determine the feasibility of using NMR to guide selection of pharmacotherapy in clinical populations of daily smokers.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Consenting participants will be assigned to guideline-based care (GBC: incorporating national guidelines and more recent evidence from clinical trials of pharmacotherapy for smoking cessation) or metabolism-informed care (MIC: identical to GBC but selection of medication based on NMR result). All participants received counseling from a nurse level certified tobacco counseling. After consent, participants undergo a blood draw for NMR, complete a baseline questionnaire, and are randomized to GBC or MIC. At approximately 1, 3, and 6 months post-consent, participants will provide follow up information via telephone questionnaire regarding symptoms, confidence in quitting, use of medications, and smoking status. At the 6-month follow-up time point, if a participant self-reports abstinence from smoking, the participant will be asked to complete a survey in-person and provide a sample of end-expired carbon monoxide for biochemical validation. At the 6 month time point, GBC participants who continue to smoke will be offered an additional phone call from the nurse tobacco counselor in which the results of the baseline NMR test will be given, along with a second prescription for a smoking cessation medication based on the NMR results (i.e., single arm crossover design). Two weeks after this additional phone call, the patient will be contacted for a final survey regarding use of medication and smoking status.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older
  • Smokes ≥ 5 cigarettes per day
  • Willing to give up all forms of tobacco (5/10/2016 - 6/27/2016)
  • Medically cleared (i.e., no contraindications in Section 3) to receive at least 2 FDA- approved smoking cessation medications
  • Willing to use the medications for which medically cleared (individually, not in combination; only applicable if Medically Cleared = Yes)

Exclusion criteria

  • Current diagnosis of schizophrenia, psychosis, active suicidal ideation, dementia, or severe mental retardation
  • Receiving palliative or hospice care
  • Currently pregnant or breastfeeding
  • Hospitalized for a psychiatric condition in the past year (5/10/2016 - 6/27/2016)
  • Hospitalized for a psychiatric condition in the past 3 months or change in psychiatric medications in last 3 months (6/28/2016 forward)
  • Telephone problems that would preclude participation (e.g., can't receive calls reliably)
  • Not able to read and speak English
  • Abstinent from cigarettes for >3 days (b/c NMR not reliable after 72 hours)
  • Used smoking cessation medications in the last 7 days (5/10/2016 - 6/27/2016)

Treatment and study plan

Nicotine Metabolite Ratio

Other

This intervention used information from a genetically-informed biomarker (Nicotine Metabolite Ratio, NMR) to assign one of 3 FDA-approved smoking cessation pharmacotherapies (varenicline, bupropion, or NRT) to participants.

Varenicline

Drug

FDA-approved smoking cessation pharmacotherapy

Other names: Chantix

bupropion

Drug

FDA-approved smoking cessation pharmacotherapy

Other names: Zyban

Nicotine patch

Drug

FDA-approved smoking cessation pharmacotherapy

Other names: Nicotine Replacement Therapy (NRT)

Primary outcomes

  1. Theoretical Endorsement of MIC as assessed by level of agreement to a set of seven 5-point Likert Scale questions

    Time frame: Baseline

    Likert Scale from Strongly Disagree to Strongly Agree on items assessing attitudes toward and perceptions of using metabolism information to guide medical care

  2. Acceptance of MIC medication recommendation as assessed by concordance between MIC recommendation and actual prescribed medication

    Time frame: At 4 weeks post-baseline

    Level of agreement between participant's prescribed medication and the medication that would be recommended based on Nicotine Metabolite Ratio

Secondary outcomes

  1. Confidence in Quitting

    Time frame: Baseline - 6 months

    Self-reported confidence in ability to quit

  2. Medication Use/Compliance

    Time frame: 1 - 6 months

    Use of prescribed medication, as directed

  3. Smoking Status

    Time frame: 6 months

    Self-reported and/or biochemically validated smoking cessation

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jul 24, 2017
Registry last updated
Jan 6, 2026

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.

Published trials that share one or more normalized conditions with this study.