Metabolism Informed Smoking Treatment: The MIST RCT

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a randomized controlled trial to compare effects of MIST versus usual care (UC) interventions on the outcomes below. Objectives: Abstinence as defined by biochemically-verified self-reported 7-day point prevalence abstinence at 6 m (1° study outcome) and 12 m (2° outcome). Clinical practice implementation as measured by participant self-reported medication adherence at months 1 and 3, self-reported receipt of prescription for smoking cessation medication after hospital discharge, and whether the prescription was tailored to the NMR result. Exploratory Objective: - Longitudinal assessment of health care utilization visits (ER and hospitalization) for 12 months following hospital discharge.

Official Title
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Metabolism Informed Smoking Treatment in Medicaid and Medicare Patients: The MIST RCT

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.
* Drug: Nicotine Replacement Therapy
* Drug: Varenicline
* Other: Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be 18 years or older be enrolled in an insurance plan that supports prescription coverage for smoking cessation medication (such as Medicare part D, Medicaid, or private insurance) to facilitate bedside delivery of medications prior to hospital discharge have a regular provider/PCP agree to quit or try to quit smoking upon hospital discharge be a daily smoker when smoking normally during the month prior to entering the hospital be medically eligible to use varenicline be medically eligible to use nicotine replacement therapy have received discharge medication recommendations from a tobacco counselor agree to take smoking cessation medication (i.e., varenicline OR nicotine replacement therapy) home and consider using it have a cell phone or landline that can be reached directly (i.e., without transfer) have a permanent address where they live and can receive mail estimated life expectancy of at least one year or greater Exclusion Criteria: insufficient time to perform and complete the enrollment process barrier to effective communication (including low English proficiency) not cognitively able to participate in the study too ill, on hospice, or physically unable to participate in the follow-up process previously completed the MIST study or is currently enrolled in a quit smoking study that involves a medication-based treatment estimated life expectancy of less than one year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIST (Metabolism-Informed Smoking Treatment)<br>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. | Behavioral: Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.<br>* Automated calls to assess smoking status, medication use, and additional support for quit attempt.<br>Drug: Nicotine Replacement Therapy<br>* FDA-approved forms of nicotine replacement therapy for smoking cessation.<br>Drug: Varenicline<br>* FDA-approved smoking cessation medication.<br>* Other names: Chantix;Other: Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)<br>* Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy. NMR is a blood test to measure how fast the body breaks down nicotine.<br>|
| Active Comparator: Usual Care<br>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. | Behavioral: Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.<br>* Automated calls to assess smoking status, medication use, and additional support for quit attempt.<br>Drug: Nicotine Replacement Therapy<br>* FDA-approved forms of nicotine replacement therapy for smoking cessation.<br>Drug: Varenicline<br>* FDA-approved smoking cessation medication.<br>* Other names: Chantix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically-validated past 7-day point prevalence tobacco abstinence |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically-validated past 7-day point prevalence tobacco abstinence |  | 12 months | 
| Self-reported medication adherence over the past 7 days |  | 1, 3 months | 
| Self-reported receipt of prescription for smoking cessation medication subsequent to the initial study medication prescription |  | Up to 12 months after hospital discharge | 
| Proportion of prescriptions reported in #3 matched to NMR result |  | Up to 12 months after hospital discharge | 
| [Exploratory] Healthcare composite outcome consisting of hospitalization, emergency department visit, and/or death within 12 months |  | 12 month period after hospital discharge |