QuitAid Pilot Feasibility Trial

Smoking Cessation Clinical Trial

Official title:

Testing the Efficacy, Feasibility and Acceptability of a Pharmacist-Delivered Medication Therapy Management Approach to Smoking Cessation for Rural Smokers in Appalachia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05649241
• Other study ID #: HSR210262
• Status: Completed
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: October 19, 2022

Study information

• Verified date: December 2022
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adult smokers were recruited through an independent pharmacy in rural Appalachia and were randomized to 1 of 8 treatments, including medication and/or therapy from the pharmacist, to help quit smoking.

Description:

24 adult smokers were recruited through an independent pharmacy in rural Appalachia were randomized to 1 of 8 treatments: (1) pharmacist delivered QuitAid intervention (Yes vs. No), (2) Combination NRT Gum + NRT Patch (vs. NRT patch), and/or (3) 8 weeks of NRT (vs. standard 4 weeks). All participants received 4 weeks of NRT patch in addition to the components to which they were assigned. Participants completed baseline and 3-month follow-up assessments. The primary outcomes were feasibility of recruitment and randomization, retention, treatment adherence and fidelity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 19, 2022
• Est. primary completion date: June 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• smokers must have smoked at least 5 cigarettes per day for the past 6 months

• be willing to set a quit date in the next 30 days

• own a cell phone

• be over 18 years of age

• not be pregnant or planning to become pregnant in the next 6 months

• not have any medical contraindications to using NRT

Exclusion Criteria:

• Those who are pregnant or plan to be

• Those under 18 years of age

• Those with a medical contradiction

• Those who do not own a cell phone

• Those who have not smoked 5 cigarettes per day for the last 6 months

• Those who are unwilling to set a quit date within 30 days

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Nicotine patch
Nicotine replacement therapy patch
• Nicotine gum
Nicotine replacement therapy gum

Behavioral:
• Medication Therapy Management
Medication therapy management delivered by pharmacist - 1 in-person coaching session, and 5 follow-up telephonic coaching sessions.

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	Feasibility of recruitment	Feasibility of recruitment was measured by (a) the proportion of smokers recruited from each source (e.g., ask-advise-connect, posters, prescription bag advertisements) and (b) the number recruited per month.	3 months
Primary	Feasibility of randomization	Feasibility of randomization was determined by the number of smokers that were approached and screened in order to randomize 24 smokers (e.g., ineligible smokers, smokers that do not consent).	3 months
Primary	Retention	Retention was assessed by the proportion of smokers who completed the 3-month follow-up.	3 months
Secondary	Tobacco Use	Biochemically verified self-reported point prevalence tobacco abstinence at the 3-month follow-up was collected	3 months