Clinical Trial

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

Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07694492
Lead Sponsor University of Virginia
Collaborators: National Cancer Institute (NCI)
Conditions Tobacco Use Cessation, Tobacco Use Disorder, Nicotine Dependence, Smokeless Tobacco Use
Enrollment 120 participants
Start Date 2026-09-01
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-10