QuitAid Pilot Feasibility Trial

December 11, 2022 updated by: Melissa Little, PhD, MPH, University of Virginia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QuitAid, 8 weeks, Patch + Gum
Participants received QuitAid, a medication therapy management delivered by their pharmacists and 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum
Drug: Nicotine patch
Nicotine replacement therapy patch
Other Names:
  • Habitrol
  • nicotine transdermal system patch
  • Nicoderm CQ
  • Nicotrol
Drug: Nicotine gum
Nicotine replacement therapy gum
Other Names:
  • nicorette
  • lucy
  • habitrol
  • pixotine
Behavioral: Medication Therapy Management
Medication therapy management delivered by pharmacist - 1 in-person coaching session, and 5 follow-up telephonic coaching sessions.
Other Names:
  • QuitAid
Experimental: QuitAid, 4 weeks, Patch + Gum
Participants received QuitAid, a medication therapy management delivered by their pharmacists and 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum
Drug: Nicotine patch
Nicotine replacement therapy patch
Other Names:
  • Habitrol
  • nicotine transdermal system patch
  • Nicoderm CQ
  • Nicotrol
Drug: Nicotine gum
Nicotine replacement therapy gum
Other Names:
  • nicorette
  • lucy
  • habitrol
  • pixotine
Behavioral: Medication Therapy Management
Medication therapy management delivered by pharmacist - 1 in-person coaching session, and 5 follow-up telephonic coaching sessions.
Other Names:
  • QuitAid
Experimental: QuitAid, 8 weeks, Patch
Participants received QuitAid, a medication therapy management delivered by their pharmacists and 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch
Drug: Nicotine patch
Nicotine replacement therapy patch
Other Names:
  • Habitrol
  • nicotine transdermal system patch
  • Nicoderm CQ
  • Nicotrol
Behavioral: Medication Therapy Management
Medication therapy management delivered by pharmacist - 1 in-person coaching session, and 5 follow-up telephonic coaching sessions.
Other Names:
  • QuitAid
Experimental: QuitAid, 4 weeks, Patch
Participants received QuitAid, a medication therapy management delivered by their pharmacists and 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch
Drug: Nicotine patch
Nicotine replacement therapy patch
Other Names:
  • Habitrol
  • nicotine transdermal system patch
  • Nicoderm CQ
  • Nicotrol
Behavioral: Medication Therapy Management
Medication therapy management delivered by pharmacist - 1 in-person coaching session, and 5 follow-up telephonic coaching sessions.
Other Names:
  • QuitAid
Experimental: No QuitAid, 8 weeks, Patch + Gum
Participants received 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum
Drug: Nicotine patch
Nicotine replacement therapy patch
Other Names:
  • Habitrol
  • nicotine transdermal system patch
  • Nicoderm CQ
  • Nicotrol
Drug: Nicotine gum
Nicotine replacement therapy gum
Other Names:
  • nicorette
  • lucy
  • habitrol
  • pixotine
Experimental: No QuitAid, 4 weeks, Patch + Gum
Participants received 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum
Drug: Nicotine patch
Nicotine replacement therapy patch
Other Names:
  • Habitrol
  • nicotine transdermal system patch
  • Nicoderm CQ
  • Nicotrol
Drug: Nicotine gum
Nicotine replacement therapy gum
Other Names:
  • nicorette
  • lucy
  • habitrol
  • pixotine
Experimental: No QuitAid, 8 weeks, Patch
Participants received 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch
Drug: Nicotine patch
Nicotine replacement therapy patch
Other Names:
  • Habitrol
  • nicotine transdermal system patch
  • Nicoderm CQ
  • Nicotrol
Experimental: No QuitAid, 4 weeks, Patch
Participants received 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch
Drug: Nicotine patch
Nicotine replacement therapy patch
Other Names:
  • Habitrol
  • nicotine transdermal system patch
  • Nicoderm CQ
  • Nicotrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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 months
Retention
Time Frame: 3 months
Retention was assessed by the proportion of smokers who completed the 3-month follow-up.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tobacco Use
Time Frame: 3 months
Biochemically verified self-reported point prevalence tobacco abstinence at the 3-month follow-up was collected
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Melissa Little, PhD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2021

Primary Completion (Actual)

June 27, 2022

Study Completion (Actual)

October 19, 2022

Study Registration Dates

First Submitted

December 4, 2022

First Submitted That Met QC Criteria

December 11, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Actual)

December 14, 2022

Last Update Submitted That Met QC Criteria

December 11, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSR210262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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