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QuitAid Pilot Feasibility Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05649241
Enrollment
24
Registered
2022-12-14
Start date
2021-08-31
Completion date
2022-10-19
Last updated
2022-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Brief 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.

Detailed 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.

Interventions

DRUGNicotine patch

Nicotine replacement therapy patch

DRUGNicotine gum

Nicotine replacement therapy gum

BEHAVIORALMedication Therapy Management

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

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

2x2x2 factorial design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of recruitment3 monthsFeasibility 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.
Feasibility of randomization3 monthsFeasibility 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).
Retention3 monthsRetention was assessed by the proportion of smokers who completed the 3-month follow-up.

Secondary

MeasureTime frameDescription
Tobacco Use3 monthsBiochemically verified self-reported point prevalence tobacco abstinence at the 3-month follow-up was collected

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026