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

University of Virginia · NCT05660525

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
768
US sites recruiting
1
Study start
March 6, 2024
Record last updated
April 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: 4 weeks of Nicotine lozenge; 8 weeks of Nicotine Replacement Therapy Patch; QuitAid; Smokefree TXT; Tobacco Quitline; 4 weeks of Nicotine Replacement Therapy Patch; 8 Weeks Nicotine Lozenge

Conditions: Smoking Cessation; Smoking, Cigarette; Smoking Reduction; Smoking; Smoking, Tobacco; Quitting Smoking

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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 USDA Rural-Urban Continuum Codes (RUCC) 4-9, Rural-Urban Commuting Area (RUCA) codes 4-10, or Frontier and Remote (FAR) areas level 4. 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)

Recruiting US locations

  • University of Virginia

    Charlottesville, VA 22904

    Site contact: Melissa A Little, PhD · 4349241935 · mal7uj@virginia.edu

Study contacts (from the official record)

  • Melissa Little, PhD, MPH · 434-924-1935 · mal7uj@virginia.edu
  • Leslie Gladney, MA · lag3z@virginia.edu
All smoking & vaping studies in Virginia →
Leveraging Community Pharmacists to Optimize Smoking Cessation… (NCT05660525) | Bored Studies