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

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

Conditions

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

Interventions

DRUG

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.

DRUG

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

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

DRUG

4 weeks of Nicotine Replacement Therapy Patch

All participants will receive at least 4 weeks of the NRT Patch.

DRUG

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.

Sponsors & Collaborators

• University of Virginia

  lead OTHER

Principal Investigators

• Melissa Little, PhD, MPH · University of Virginia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-03-06

Primary Completion

2027-05-31

Completion

2028-03-01

Countries

• United States

Study Locations