Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT04590404
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2020-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Metabolism Informed Smoking Treatment: The MIST RCT
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Study Overview
Official Title:
Metabolism Informed Smoking Treatment in Medicaid and Medicare Patients: The MIST RCT
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5R01CA232516-03 | NIH | None | https://reporter.nih.gov/quic… | View |