Leveraging Community Pharmacists to Optimize Smoking Cessation Services for Rural Smokers in Appalachia

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT05660525
Status
Recruiting
Apply to this trial

Conditions

  • Quitting Smoking
  • Smoking
  • Smoking Cessation
  • Smoking Reduction
  • Smoking, Cigarette
  • Smoking, Tobacco

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 4 weeks of Nicotine lozenge — DRUG
    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 — DRUG
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 — DRUG
    All participants will receive at least 4 weeks of the NRT Patch.
  • 8 Weeks Nicotine Lozenge — DRUG
    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.

Study Details

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 Dates

Start date
Mar 6, 2024
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
768 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: QuitAid, 4 weeks, Patch + Lozenge
    Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge.
  • Experimental: QuitAid, 8 weeks, Patch + Lozenge
    Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge.
  • Experimental: QuitAid, 4 weeks, Patch + Lozenge, QuitLine
    Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention
  • Experimental: QuitAid, 8 weeks, Patch + Lozenge, QuitLine
    Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention
  • Experimental: QuitAid, 4 weeks, Patch
    Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.
  • Experimental: QuitAid, 8 weeks, Patch
    Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.
  • Experimental: QuitAid, 8 weeks, Patch, QuitLine
    Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline intervention
  • Experimental: QuitAid, 4 weeks, Patch, QuitLine
    Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline intervention
  • Experimental: QuitAid, 4 weeks, Patch, SmokeFree Txt
    Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a texting intervention to help quit smoking.
  • Experimental: QuitAid, 8 weeks, Patch, SmokeFree Txt
    Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a texting intervention to help quit smoking.
  • Experimental: QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt
    Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking.
  • Experimental: QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt
    Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking.
  • Experimental: QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine
    Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
  • Experimental: QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine
    Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
  • Experimental: QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine
    Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
  • Experimental: QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLine
    Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
  • Experimental: 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine
    Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
  • Experimental: 8 weeks, Patch, SmokeFree Txt, QuitLine
    Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
  • Experimental: 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine
    Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
  • Experimental: 4 weeks, Patch, SmokeFree Txt, QuitLine
    Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
  • Experimental: 8 weeks, Patch + Lozenge, QuitLine
    Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention.
  • Experimental: 8 weeks, Patch, QuitLine
    Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention.
  • Experimental: 4 weeks, Patch + Lozenge, QuitLine
    Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention.
  • Experimental: 4 weeks, Patch, QuitLine
    Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention.
  • Experimental: 8 weeks, Patch + Lozenge, SmokeFree Txt
    Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge and a texting intervention to help quit smoking.
  • Experimental: 8 weeks, Patch, SmokeFree Txt
    Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and a texting intervention to help quit smoking.
  • Experimental: 4 weeks, Patch + Lozenge, SmokeFree Txt
    Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge and a texting intervention to help quit smoking.
  • Experimental: 4 weeks, Patch, SmokeFree Txt
    Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and a texting intervention to help quit smoking.
  • Experimental: 8 weeks, Patch + Lozenge
    Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge.
  • Experimental: 8 weeks, Patch
    Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.
  • Experimental: 4 weeks, Patch + Lozenge
    Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge.
  • Experimental: 4 weeks, Patch
    Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.

Primary Outcome Measure

Tobacco Abstinence [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22904
Melissa A Little, PhD
[email protected]
4349241935

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University of Virginia· Charlottesville, VA

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