Phase 3
Completed N=601
Metabolism Informed Smoking Treatment: The MIST RCT
Source: ClinicalTrials.gov NCT04590404 ↗Enrolled (actual)
601
Serious AEs
45.1%
Results posted
Jun 2025
Primary outcomePrimary: Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence — 54; 49 Participants — p=0.461
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence |
49; 51 | 0.99 |
| SECONDARY Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence |
49; 51 | 0.99 |
| SECONDARY Self-reported Medication Adherence Over the Past 7 Days |
234; 232 | — |
| SECONDARY Self-reported Receipt of Prescription for Smoking Cessation Medication Subsequent to the Initial Study Medication Prescription |
70; 74 | — |
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
Data sourced from ClinicalTrials.gov (NCT04590404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.