← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.
Select...
I am cleared to use varenicline by a healthcare professional.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Biochemically-validated past 7-day point prevalence tobacco abstinence
Proportion of prescriptions reported in #3 matched to NMR result
Self-reported medication adherence over the past 7 days
+2 more

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
~9020
Varenicline
2011
Completed Phase 4
~4170

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,951,931 Total Patients Enrolled
35 Trials studying Smoking
13,607 Patients Enrolled for Smoking
Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,325 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,923,881 Total Patients Enrolled
63 Trials studying Smoking
53,495 Patients Enrolled for Smoking

Media Library

Nicotine Replacement Therapy (Nicotine Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04590404 — Phase 3
Smoking Research Study Groups: Usual Care, MIST (Metabolism-Informed Smoking Treatment)
Smoking Clinical Trial 2023: Nicotine Replacement Therapy Highlights & Side Effects. Trial Name: NCT04590404 — Phase 3
Nicotine Replacement Therapy (Nicotine Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04590404 — Phase 3
Smoking Patient Testimony for trial: Trial Name: NCT04590404 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What do medical professionals usually prescribe Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy) for?

"Metabolism Informed Smoking Treatment (MIST), which uses the nicotine metabolite ratio (NMR) to choose the right pharmacotherapy, can help patients quit smoking and manage dry eye syndrome."

Answered by AI

Could you please tell us about other research that has used Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR) to choose a smoking cessation pharmacotherapy)?

"As of right now, there are 91 Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy) studies underway, 7 of which are in Phase 3. Some of the Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy) trials are happening in Oconto Falls, Wisconsin, but there are a total of 264 locations running these types of studies."

Answered by AI

Are researchers looking for more participants for this trial?

"Yes, this clinical trial is open and recruiting patients, as reflected on clinicaltrials.gov. This research was first made public on November 17th, 2020, with the most recent update on July 29th, 2022."

Answered by AI

Is Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy) an FDA-regulated therapy?

"Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy) has been given a safety rating of 3."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
65+
What site did they apply to?
Vanderbilt University Medical Center ViTAL, Vanderbilt Center for Tobacco, Addiction, and Lifestyle General Internal Medicine and Public Health 2525 West End Ave, Suite 450
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have tried to quit smoking for over the last 20 years and have not been successful. I have tried the medication (I can't remember the name) tried it twice with no results. I tried a study which was just reading material and that didn't work. I tried cold turkey-of course that did not work. Onee time I did taper and quit for a year but I had a relationship issue and I started again right at the one year mark, that was over 20 years ago. So I really need your help. I love Vanderbilt. My husband has had numerous surgeries there and has spent quite a bit of time in the Burn Center and we love all the staff and people we have met throughout the facility.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Metabolism Informed Smoking Treatment: The MIST RCT
Hilary Tindle 2020. "Metabolism Informed Smoking Treatment: The MIST RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04590404.
All > Chantix
~185 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top