Clinical trial NCT04590404: Metabolism Informed Smoking Treatment: The MIST RCT
Official title: Metabolism Informed Smoking Treatment in Medicaid and Medicare Patients: The MIST RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2020-10-19
Enrollment: 606
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).
* 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.

Eligibility 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
* 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

Primary outcomes:
measure: Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence
timeFrame: 6 months
Secondary outcomes:
measure: Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence
timeFrame: 12 months
measure: Self-reported Medication Adherence Over the Past 7 Days
timeFrame: 1, 3 months
measure: Self-reported Receipt of Prescription for Smoking Cessation Medication Subsequent to the Initial Study Medication Prescription
timeFrame: Up to 12 months after hospital discharge
measure: [Exploratory] Healthcare Composite Outcome Consisting of Hospitalization, Emergency Department Visit, and/or Death Within 12 Months
timeFrame: 12 month period after hospital discharge
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center ViTAL, Vanderbilt Center for Tobacco, Addiction, and Lifestyle General Internal Medicine and Public Health 2525 West End Ave, Suite 450
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Hilary Tindle, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: