606 Participants Needed

Tailored Smoking Cessation Therapy for Smoking Addiction

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Overseen ByStephen M King
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Vanderbilt-Ingram Cancer Center
Must be taking: Varenicline, Nicotine replacement
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

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Hilary Tindle, MD, MPH

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

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 9 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either MIST or Usual Care interventions, with medication prescriptions tailored or not tailored to nicotine metabolism

6 months
Automated phone calls post-discharge

Follow-up

Participants are monitored for abstinence and clinical practice implementation at 6 and 12 months

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)
  • Nicotine Replacement Therapy
  • Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach
  • Varenicline
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: MIST (Metabolism-Informed Smoking Treatment)Experimental Treatment4 Interventions
Group II: Usual CareActive Control3 Interventions

Nicotine Replacement Therapy is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as NRT for:
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Approved in European Union as NRT for:
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Approved in Canada as NRT for:
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Approved in Japan as NRT for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials
221
Recruited
64,400+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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