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Nicotine Replacement Therapy

Tailored Smoking Cessation Therapy for Smoking Addiction

Phase 3

Waitlist Available

Led By Hilary Tindle, MD, MPH

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

be 18 years or older

be medically eligible to use varenicline

Must not have

too ill, on hospice, or physically unable to participate in the follow-up process

not cognitively able to participate in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test if Metabolism-Informed Smoking Treatment, which tailors medication selection to nicotine metabolism, is more effective than usual care.

Who is the study for?

This trial is for daily smokers over 18 with a regular healthcare provider, who are willing to try quitting smoking after hospital discharge. They must be able to use nicotine replacement or varenicline, have phone access, a permanent address, and prescription coverage. Those too ill, in hospice care, not cognitively able to participate or already in another smoking study can't join.

What is being tested?

The MIST RCT is testing tailored smoking cessation treatments based on how fast individuals metabolize nicotine. Participants will receive either standard Nicotine Replacement Therapy or Varenicline guided by their Nicotine Metabolite Ratio (NMR), along with automated follow-up calls and tobacco coaching.

What are the potential side effects?

Possible side effects include nausea, headaches, difficulty sleeping and unusual dreams with Varenicline; skin irritation from patches and mouth/throat issues from lozenges/gum for Nicotine Replacement Therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am cleared to use varenicline by a healthcare professional.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am too sick, in hospice care, or unable to follow up as required.

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I am mentally capable of participating in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MIST (Metabolism-Informed Smoking Treatment)Experimental Treatment4 Interventions

At hospital discharge, participants randomized to the MIST precision care arm will receive a prescription for medication (either varenicline or NRT). Post discharge, participants will receive automated phone calls via TelASK to promote continued engagement. Medication prescriptions will be informed by nicotine metabolism (i.e., NMR result) such that faster metabolizers are prescribed varenicline and slower metabolizers are prescribed NRT.

Group II: Usual CareActive Control3 Interventions

At hospital discharge, participants randomized to the Usual Care arm will receive a prescription for medication (either varenicline or NRT). Post discharge, participants will receive automated phone calls via TelASK to promote continued engagement. Medication prescription will not be informed by nicotine metabolism.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotine Replacement Therapy

2019

Completed Phase 4

~8830

Varenicline

2011

Completed Phase 4

~4170