Metabolism Informed Smoking Treatment: The MIST RCT
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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).
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MIST (Metabolism-Informed Smoking Treatment) 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.
Automated calls to assess smoking status, medication use, and additional support for quit attempt.
Drug: Nicotine Replacement Therapy
FDA-approved forms of nicotine replacement therapy for smoking cessation.
Drug: Varenicline
FDA-approved smoking cessation medication.
Other Names:
Other: Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)
Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy. NMR is a blood test to measure how fast the body breaks down nicotine.
|
| Active Comparator: Usual Care 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.
Automated calls to assess smoking status, medication use, and additional support for quit attempt.
Drug: Nicotine Replacement Therapy
FDA-approved forms of nicotine replacement therapy for smoking cessation.
Drug: Varenicline
FDA-approved smoking cessation medication.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Biochemically-validated past 7-day point prevalence tobacco abstinence [6 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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
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agree to quit or try to quit smoking upon hospital discharge
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be a daily smoker when smoking normally during the month prior to entering the hospital
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be medically eligible to use varenicline
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be medically eligible to use nicotine replacement therapy
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have received discharge medication recommendations from a tobacco counselor
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agree to take smoking cessation medication (i.e., varenicline OR nicotine replacement therapy) home and consider using it
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have a cell phone or landline that can be reached directly (i.e., without transfer)
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have a permanent address where they live and can receive mail
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estimated life expectancy of at least one year or greater
Exclusion Criteria:
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insufficient time to perform and complete the enrollment process
-
barrier to effective communication (including low English proficiency)
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanderbilt University Medical Center ViTAL, Vanderbilt Center for Tobacco, Addiction, and Lifestyle General Internal Medicine and Public Health 2525 West End Ave, Suite 450 | Nashville | Tennessee | United States | 37203 |
Sponsors and Collaborators
- Vanderbilt-Ingram Cancer Center
- National Cancer Institute (NCI)
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Hilary Tindle, MD, MPH, Vanderbilt University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VICC THO 2046
- 5R01CA232516-02