CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 82 enrolled
Drug / intervention
Varenicline +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03227679
NCT03227679N/ACompleted

Metabolism-informed Care for Smoking Cessation

Vanderbilt University Medical Center·interventional·Posted Jul 24, 2017·Updated Jan 6, 2026

In Brief

A clinical study evaluating Nicotine Metabolite Ratio, Varenicline, and 2 other interventions for Tobacco Use and Tobacco Use Cessation. Completed, enrolled 82 participants.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 24, 2017
Enrollment StartMay 18, 2016
Primary CompletionOct 8, 2016
Study CompletionApr 18, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.9 years ago

Interventions

Nicotine Metabolite Ratioother

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.

Vareniclinedrug

FDA-approved smoking cessation pharmacotherapy

Bupropiondrug

FDA-approved smoking cessation pharmacotherapy

Nicotine patchdrug

FDA-approved smoking cessation pharmacotherapy