Clinical trialNCT07694492Not, yet, recruitingInterventional

Feasibility of a Medical-Legal Partnership Model to Connect Coal Miners QuitAid

SponsorUniversity of VirginiaEnrollment120Nicotine DependenceSmokeless Tobacco UseTobacco Use CessationTobacco Use Disorder

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Coal miners in Central Appalachia have among the highest rates of tobacco and nicotine product (TNP) use of any occupational group and face elevated rates of lung cancer and coal workers' pneumoconiosis ("black lung"). This study tests a novel medical-legal partnership (MLP) that "flips" the traditional referral direction: lawyers representing coal miners in black-lung workers' compensation cases identify clients who use TNPs and, through an ask-advise-connect process, connect them to community pharmacists who deliver QuitAid, a pharmacist-delivered medication therapy management (MTM) program, together with nicotine replacement therapy (NRT). The study has two aims: (1) an implementation-science evaluation of the ask-advise-connect process in black-lung law offices, and (2) a randomized feasibility pilot in which coal miners who use TNPs are randomized to receive QuitAid or not, with all participants receiving 24 weeks of NRT. As a feasibility pilot, the study is designed to estimate recruitment, randomization, retention, fidelity, and dose parameters to inform a future NCI R01, and is not powered to detect differences between conditions.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Drew Harris, MD
University of Virginia
Principal Investigator
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Melissa A Little, PhD, MPH
University of Virginia
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Virginia
Charlottesville, Virginia, United States
Candace H Wood, PharmDDrew Harris, MDMelissa A Little, PhD, MPHRoger T Anderson, PhD

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Nicotine Replacement Therapy

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Sept 2026
Primary completion: 30 Sept 2027
Completion: 31 Dec 2027
Last update posted: 10 Jul 2026
Registered enrollment: 120
Registry id: NCT07694492

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.