Tailored Smoking Cessation Therapy for Smoking Addiction

Overseen By Stephen M King

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vanderbilt-Ingram Cancer Center

Must be taking: Varenicline, Nicotine replacement

Disqualifiers: Low English proficiency, Cognitive impairment, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

608 Participants Needed

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)

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: MIST (Metabolism-Informed Smoking Treatment) Experimental Treatment 4 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 Care Active Control 3 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 United States, European Union, Canada, Japan for the following indications:

Approved in United States as NRT for:

• Smoking cessation

Approved in European Union as NRT for:

• Smoking cessation

Approved in Canada as NRT for:

• Smoking cessation

Approved in Japan as NRT for:

• Smoking cessation

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+