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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
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 belowSelect...
I am 18 years old or older.
Select...
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:Select...
I am too sick, in hospice care, or unable to follow up as required.
Select...
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
Treatment Details
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
~8790
Varenicline
2011
Completed Phase 4
~4170
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,132,903 Total Patients Enrolled
36 Trials studying Smoking
16,807 Patients Enrolled for Smoking
Vanderbilt-Ingram Cancer CenterLead Sponsor
215 Previous Clinical Trials
62,447 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,392 Total Patients Enrolled
66 Trials studying Smoking
57,887 Patients Enrolled for Smoking
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can safely use nicotine replacement therapy.I am too sick, in hospice care, or unable to follow up as required.I have finished the MIST study or am in a quit smoking study using medication.I am 18 years old or older.I am mentally capable of participating in the study.I am cleared to use varenicline by a healthcare professional.Doctors think you might not live for more than a year.I am willing to try smoking cessation medication.My insurance covers prescription smoking cessation meds.I have received advice on quitting smoking from a tobacco counselor.I agree to consider using smoking cessation medication recommended by a tobacco counselor.You have been smoking every day for the month before coming to the hospital.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: MIST (Metabolism-Informed Smoking Treatment)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Smoking Patient Testimony for trial: Trial Name: NCT04590404 — Phase 3
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