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Leveraging Community Pharmacists to Optimize Smoking Cessation Services for Rural Smokers in Appalachia
Sponsor: University of Virginia
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
768
Start Date
2024-03-06
Completion Date
2028-03-01
Last Updated
2025-10-30
Healthy Volunteers
Yes
Conditions
Interventions
4 weeks of Nicotine lozenge
All participants will receive at least 4 weeks of the NRT Patch. Some will be randomized to receive 4 weeks of lozenge in addition to the NRT Patch. NRT temporarily replaces nicotine from tobacco to reduce motivation to consume tobacco and nicotine withdrawal symptoms.
8 weeks of Nicotine Replacement Therapy Patch
All participants will receive at least 4 weeks of the NRT Patch. Some will also be randomized to receive an additional 4 weeks of the NRT Patch
QuitAid
All participants will receive at least 4 weeks of the NRT Patch. Some participants will also be randomized to receive the QuitAid intervention, based on a medication adherence intervention, addresses perceptions (e.g., motivation, self-efficacy, beliefs) and practicalities of using NRT (e.g., monitoring NRT use, establishing a reminder system). QuitAid includes 1 in-person session and 5 follow-up telephonic sessions with the participant's local pharmacist/technician.
Smokefree TXT
All participants will receive at least 4 weeks of the NRT Patch. Some participants will also be randomized to receive the SmokefreeTXT is a text-messaging program offered through the National Cancer Institute's Smokefree.gov initiative, which sends pre-programmed messages timed around a quit date. Participants will receive 3-5 messages a day for 7 weeks. The first week of messages focus on preparation and the remaining 6 weeks of messages focus on post-cessation strategies (e.g., relapse prevention), all timed relative to the quit date set at enrollment.
Tobacco Quitline
All participants will receive at least 4 weeks of the NRT Patch. Some participants will also be randomized to receive a 4-session proactive tobacco quitline, with each session lasting 20-30 minutes and occurring on days 7, 14, 21 and 28.The quitline intervention incorporates 3 phases: (1) preparing to quit, (2) quitting process, and (3) relapse prevention.
4 weeks of Nicotine Replacement Therapy Patch
All participants will receive at least 4 weeks of the NRT Patch.
8 Weeks Nicotine Lozenge
All participants will receive at least 4 weeks of the NRT Patch. Some will be randomized to receive 8 weeks of lozenge in addition to the NRT Patch. NRT temporarily replaces nicotine from tobacco to reduce motivation to consume tobacco and nicotine withdrawal symptoms.
Locations (1)
University of Virginia
Charlottesville, Virginia, United States