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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05660525
• Other study ID #: HSR220197
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2024
• Est. completion date: March 1, 2028

Study information

• Verified date: March 2024
• Source: University of Virginia
• Contact: Melissa Little, PhD, MPH
• Phone: 434-924-1935
• Email: mal7uj[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The proposed study uses a mixed-method design to evaluate the effectiveness and implementation of a pharmacist-delivered MTM (Medication Therapy Management) approach, called QuitAid, to smoking cessation in rural Appalachia. Aim 1 of this project will evaluate the effectiveness of QuitAid and standard, evidence-based tobacco treatments on cessation within an MTM pharmacist-delivered approach. Aim 2 will assess implementation, including relative cost of QuitAid, as well as standard, evidence-based tobacco treatments through an ask-advise-connect model, in community pharmacies, and will examine facilitators and barriers to reach, adoption, and maintenance of QuitAid as well as standard, evidence-based tobacco treatments through an ask-advise-connect method in community pharmacies. Smokers (n=768) recruited through 14 community pharmacies in rural Appalachia will be randomized in a 2x2x2x2x2 full factorial experiment to the following five treatments: (1) QuitAid Intervention (Yes vs. No), (2) tobacco quitline (Yes vs. No), (3) SmokefreeTXT through the National Cancer Institute's (NCI) Smokefree.gov initiative (Yes vs. No), (4) Combination NRT Lozenge + NRT Patch (vs. NRT patch alone), and/or (5) 8 weeks of NRT (vs. standard 4 weeks). Following the experimental trial, we will use an implementation science approach to assess implementation, including relative cost, as well as facilitators and barriers of reach, adoption, and maintenance of QuitAid and standard, evidence-based tobacco treatments through an ask-advise-connect method in community pharmacies (Aim 2).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 768
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 RUCA codes 4-10. 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)

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.

Drug:
• 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

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	Self-Reported Tobacco Abstinence	Self-reported point prevalence abstinence defined as no smoking (even a puff) within the past 7 days	1, 2, and 3 months
Secondary	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.	1, 2, and 3 months
Secondary	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)	1, 2, and 3 months