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
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
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)
Factorial
4 weeks of Nicotine lozenge
DrugAll 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
DrugAll 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
BehavioralAll 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
BehavioralAll 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
BehavioralAll 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
DrugAll participants will receive at least 4 weeks of the NRT Patch.
8 Weeks Nicotine Lozenge
DrugAll 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.
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Treatment groupsSee each treatment group below.
Tobacco Abstinence
The primary outcome is biochemically verified point prevalence (verified through a CO test via Smokerlyzer at endpoint of participation in trial) abstinence defined as no smoking (even a puff) within the past 7 days.
Self-Reported Tobacco Abstinence
Self-reported point prevalence abstinence defined as no smoking (even a puff) within the past 7 days
Adherence to assigned treatment components
Assess adherence to assigned treatment regimen as the percentage of sessions completed if the participant was assigned to QuitAid and/or the quitline treatments, the frequency of opt-out from SmokefreeTXT (e.g., texting "STOP"), and the percent of NRT used. Adherence to NRT (both patch and/or lozenge) will be collected from participants at the 1-, 2-, and 3-month follow-ups.
Quit Attempts
Assess the number of times that participants have made a quit attempt since the previous contact at the 1-, 2-, 3- and 6-month follow-ups. A "quit attempt" will be defined as cigarette abstinence for ≥ 24 hours not due to involuntary or forced cessation (i.e., hospitalization)
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