NCT05660525 Leveraging Community Pharmacists to Optimize Smoking Cessation Services for Rural Smokers in Appalachia
| NCT ID | NCT05660525 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Virginia |
| Condition | Smoking Cessation |
| Study Type | INTERVENTIONAL |
| Enrollment | 768 participants |
| Start Date | 2024-03-06 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 768 participants in total. It began in 2024-03-06 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the effectiveness and implementation of a pharmacist-delivered MTM (medication therapy management) approach, called QuitAid, to quitting cigarette smoking in rural Appalachia. The main questions it aims to answer are: * Is QuitAid, alone or combined with other quitting tobacco treatments, effective? * What makes QuitAid easy or hard to carry out? Is it cost effective? Is it easy to maintain? Treatment: All participants will be given at least 4 weeks of the nicotine patch. Some participants will be randomized (like the flip of a coin) to receive additional treatments (listed below). These groups will be compared to each other to see which combination works best to help them quit smoking. * Smokefree TXT - a texting program that helps people quit smoking * Tobacco quitline - 4 phone sessions to help people quit smoking * 8 weeks of NRT (nicotine replacement therapy in the form of nicotine patches or nicotine patches and lozenge) medication instead of 4 weeks * QuitAid - An MTM program given by the patient's pharmacist. This is a quitting smoking coaching program * Nicotine patch AND nicotine lozenge instead of just nicotine patches
Eligibility Criteria
Study participants will be rural cigarette smokers from Virginia, Tennessee, Kentucky and North Carolina who visit one of the participating study pharmacies. Pharmacies will be located in rural geographic areas of the Central and South Central subregions of Appalachia that include Virginia, Tennessee, Kentucky and North Carolina, as defined by the USDA Rural-Urban Continuum Codes (RUCC) 4-9, Rural-Urban Commuting Area (RUCA) codes 4-10, or Frontier and Remote (FAR) areas level 4. No exclusionary criteria are based on race, gender, or age. Inclusion Criteria include: * must be 18 years of age and older * must be able to read, speak, and understand English * must report smoking at least 5 cigarettes per day for the past 6 months (regardless of non-cigarette tobacco product use) * must be willing to set a quit date within the next 30 days * must own a cell phone * must be willing and able to use NRT in the form of patch or lozenge * Not be pregnant or planning to be pregnant in the next 6 months. Exclusion Criteria include: * are pregnant women (self-reported), breastfeeding, planning to become pregnant during the next 6 months * have a medical contraindication to NRT (e.g., past 30 days, heart attack or stroke; past 6 months, serious or worsening angina, very rapid or irregular heartbeat requiring medication)
Contact & Investigator
Melissa Little, PhD, MPH
PRINCIPAL INVESTIGATOR
University of Virginia
Frequently Asked Questions
Who can join the NCT05660525 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Smoking Cessation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05660525 currently recruiting?
Yes, NCT05660525 is actively recruiting participants. Contact the research team at mal7uj@virginia.edu for enrollment information.
Where is the NCT05660525 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT05660525 clinical trial?
NCT05660525 is sponsored by University of Virginia. The principal investigator is Melissa Little, PhD, MPH at University of Virginia. The trial plans to enroll 768 participants.