Smoking
Conditions
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.
Interventions
BEHAVIORALPost-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.
DRUGNicotine Replacement Therapy
FDA-approved forms of nicotine replacement therapy for smoking cessation.
DRUGVarenicline
FDA-approved smoking cessation medication.
OTHERMetabolism 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.
Sponsors
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Vanderbilt-Ingram Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence | 12 months | — |
| Self-reported Medication Adherence Over the Past 7 Days | 1, 3 months | Participants taking any stop-smoking medications in past 7 days at 1 AND/OR 3 month surveys, also includes those who reported completing their course of medication at 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 | Randomized participants who reported having an office visit with PCP or regular healthcare provider and reported receiving a medication recommendation or prescription (since study enrollment; 1, 3, 6, or 12 months). Some participants may have reported receiving more than 1 prescription over the course of the 12 months. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from a tertiary care hospital in the US Mid-South from November 17, 2020 to September 29, 2023.
Pre-assignment details
5 participants were removed pre-randomization assignment by PI due to new information, discovered post-consent, indicating ineligibility.
Participants by arm
| Arm | Count |
|---|---|
| MIST (Metabolism-Informed Smoking Treatment) All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. The MIST intervention used NMR to select medication (Fast Metabolizers NMR≥0.31-varenicline; Slow Metabolizers NMR \<0.31-NRT). | 294 |
| Guideline-Based Care All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. Medication was selected by shared decision making. Guideline-based care participants were not informed of NMR results. | 307 |
| Total | 601 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 16 | 17 |
| Overall Study | Withdrawal by Subject | 7 | 2 |
Baseline characteristics
| Characteristic | MIST (Metabolism-Informed Smoking Treatment) | Guideline-Based Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 63 Participants | 87 Participants | 150 Participants |
| Age, Categorical Between 18 and 65 years | 231 Participants | 220 Participants | 451 Participants |
| Age, Continuous | 55.88 years STANDARD_DEVIATION 11.6 | 56.45 years STANDARD_DEVIATION 11.53 | 56.17 years STANDARD_DEVIATION 11.56 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 287 Participants | 300 Participants | 587 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 58 Participants | 66 Participants | 124 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 7 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 224 Participants | 239 Participants | 463 Participants |
| Region of Enrollment United States | 294 participants | 307 participants | 601 participants |
| Sex: Female, Male Female | 127 Participants | 136 Participants | 263 Participants |
| Sex: Female, Male Male | 167 Participants | 171 Participants | 338 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 16 / 294 | 17 / 307 |
| other Total, other adverse events | 84 / 294 | 90 / 307 |
| serious Total, serious adverse events | 140 / 294 | 131 / 307 |
Outcome results
Primary
Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence
Time frame: 6 months
Population: Randomized participants were analyzed. Participants with missing self-report or biochemical verification data were assumed to be smoking (missing=smoking).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MIST (Metabolism-Informed Smoking Treatment) | Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence | 54 Participants |
| Guideline-Based Care | Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence | 49 Participants |
Comparison: The primary outcome was biochemically-verified self-reported 7-day point prevalence abstinence (7dPPA) at 6 months. We modeled outcomes using logistic regression adjusted for randomization stratification factors and plan to quit (stay quit vs. try).p-value: 0.46195% CI: [0.76, 1.82]Regression, Logistic
Secondary
Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence
Time frame: 12 months
Population: Randomized participants were analyzed. Participants with missing self-report or biochemical verification data were assumed to be smoking (missing=smoking).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MIST (Metabolism-Informed Smoking Treatment) | Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence | 49 Participants |
| Guideline-Based Care | Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence | 51 Participants |
Comparison: The primary outcome was biochemically-verified self-reported 7-day point prevalence abstinence (7dPPA) at 12 months. We modeled outcomes using logistic regression adjusted for randomization stratification factors and plan to quit (stay quit vs. try).p-value: 0.9995% CI: [0.64, 1.54]Regression, Logistic
Secondary
Self-reported Medication Adherence Over the Past 7 Days
Participants taking any stop-smoking medications in past 7 days at 1 AND/OR 3 month surveys, also includes those who reported completing their course of medication at 3 months.
Time frame: 1, 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MIST (Metabolism-Informed Smoking Treatment) | Self-reported Medication Adherence Over the Past 7 Days | 234 Participants |
| Guideline-Based Care | Self-reported Medication Adherence Over the Past 7 Days | 232 Participants |
Secondary
Self-reported Receipt of Prescription for Smoking Cessation Medication Subsequent to the Initial Study Medication Prescription
Randomized participants who reported having an office visit with PCP or regular healthcare provider and reported receiving a medication recommendation or prescription (since study enrollment; 1, 3, 6, or 12 months). Some participants may have reported receiving more than 1 prescription over the course of the 12 months.
Time frame: Up to 12 months after hospital discharge
Population: Of note, 395 participants were missing for this measure due to report of not having an office visit and/or non-completion of all follow-up surveys.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MIST (Metabolism-Informed Smoking Treatment) | Self-reported Receipt of Prescription for Smoking Cessation Medication Subsequent to the Initial Study Medication Prescription | 70 Participants |
| Guideline-Based Care | Self-reported Receipt of Prescription for Smoking Cessation Medication Subsequent to the Initial Study Medication Prescription | 74 Participants |