SmokingPhase 3NCT04590404
Metabolism Informed Smoking Treatment: The MIST RCT
A Phase 3 study testing Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach., Nicotine Replacement Therapy and Varenicline in people with Smoking, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach., Nicotine Replacement Therapy and Varenicline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 606 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2020to 22 Nov 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
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, 37203
About this study
Official title: Metabolism Informed Smoking Treatment in Medicaid and Medicare Patients: The MIST RCT
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.
Read the 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.
- Conditions
- Smoking
- Being tested
- Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach., Nicotine Replacement Therapy, Varenicline, Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.Behavioural
Automated calls to assess smoking status, medication use, and additional support for quit attempt.
Nicotine Replacement TherapyDrug
FDA-approved forms of nicotine replacement therapy for smoking cessation.
VareniclineDrug
Also called Chantix
FDA-approved smoking cessation medication.
Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)Other
Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy. NMR is a blood test to measure how fast the body breaks down nicotine.
| Study group | Role | What they receive |
|---|---|---|
| MIST (Metabolism-Informed Smoking Treatment) | Experimental | 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. Receives: 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) |
| Usual Care | Active comparator | 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. Receives: Behavioral: Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.; Drug: Nicotine Replacement Therapy; Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence
Measured: 6 months
Secondary outcomes (3)
Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence
Measured: 12 months
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.
Measured: 1, 3 months
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.
Measured: Up to 12 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start17 Nov 2020
- Primary completion20 May 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Hilary Tindle, Vanderbilt-Ingram Cancer Center
- Investigators
- Hilary Tindle, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590404
- Sponsor's protocol ID
- VICC THO 2046
- Other IDs
- 5R01CA232516-03
- Status last verified
- Nov 2025
- First submitted
- 5 Oct 2020
- Last updated
- 5 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism Informed Smoking Treatment in Medicaid and Medicare Patients: The MIST RCT
- ClinicalTrials.gov ID
- NCT04590404
- Acronym / sponsor ID
- VICC THO 2046
- Conditions
- Smoking
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 5 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIST (Metabolism-Informed Smoking Treatment) | Experimental | 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)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. |
| Usual Care | Active comparator | Behavioral: Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach., Drug: Nicotine Replacement Therapy, Drug: VareniclineAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | MIST (Metabolism-Informed Smoking Treatment), Usual Care |
| Nicotine Replacement TherapyFDA-approved forms of nicotine replacement therapy for smoking cessation. | Drug | MIST (Metabolism-Informed Smoking Treatment), Usual Care |
| VareniclineAlso: ChantixFDA-approved smoking cessation medication. | Drug | MIST (Metabolism-Informed Smoking Treatment), Usual Care |
| 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. | Other | MIST (Metabolism-Informed Smoking Treatment) |
Primary outcome
Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence
Time frame: 6 months
3 secondary outcomes
Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence
Time frame: 12 months
Self-reported Medication Adherence Over the Past 7 Days
Time frame: 1, 3 months
Self-reported Receipt of Prescription for Smoking Cessation Medication Subsequent to the Initial Study Medication Prescription
Time frame: Up to 12 months after hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilary Tindle, MD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach., Nicotine Replacement Therapy and Varenicline in people with Smoking, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.