Tailored Smoking Cessation Therapy for Smoking Addiction

Recruiting in Palo Alto (17 mi)

Overseen byHilary Tindle, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Vanderbilt-Ingram Cancer Center

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase 3 randomized controlled trial will test Metabolism-Informed Smoking Treatment (MIST), a precision approach to smoking treatment that biologically tailors medication selection to nicotine metabolism.

Research Team

Hilary Tindle, MD, MPH

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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.

Inclusion Criteria

have a regular provider/PCP

I can safely use nicotine replacement therapy.

have a cell phone or landline that can be reached directly (i.e., without transfer)

See 10 more

Exclusion Criteria

insufficient time to perform and complete the enrollment process

barrier to effective communication (including low English proficiency)

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

See 3 more

Treatment Details

Interventions

Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy) (Procedure)
Nicotine Replacement Therapy (Nicotine Replacement Therapy)
Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach (Behavioural Intervention)
Varenicline (Smoking Cessation Agent)

Trial OverviewThe 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.

Participant Groups

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.

Nicotine Replacement Therapy is already approved in Canada, Japan for the following indications:

Approved in Canada as NRT for:

Smoking cessation

Approved in Japan as NRT for:

Smoking cessation

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Vanderbilt University Medical Center ViTAL, Vanderbilt Center for Tobacco, Addiction, and Lifestyle General Internal Medicine and Public Health 2525 West End Ave, Suite 450Nashville, TN

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