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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 19, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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