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OpenTrials
Completed

NCT Number: NCT05649241

QuitAid Pilot Feasibility Trial

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.

Completed

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine patch

Drug

Nicotine replacement therapy patch

Other names: Nicoderm CQ, nicotine transdermal system patch, Habitrol, Nicotrol

Nicotine gum

Drug

Nicotine replacement therapy gum

Other names: nicorette, lucy, habitrol, pixotine

Medication Therapy Management

Behavioral

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

Other names: QuitAid

Primary outcomes

  1. Feasibility of recruitment

    Time frame: 3 months

    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.

  2. Feasibility of randomization

    Time frame: 3 months

    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. Retention

    Time frame: 3 months

    Retention was assessed by the proportion of smokers who completed the 3-month follow-up.

Secondary outcomes

  1. Tobacco Use

    Time frame: 3 months

    Biochemically verified self-reported point prevalence tobacco abstinence at the 3-month follow-up was collected

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 14, 2022
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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