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QuitAid Pilot Feasibility Trial

Sponsor
University of Virginia (Other)
Overall Status
Completed
CT.gov ID
NCT05649241
Collaborator
(none)
24
Enrollment
1
Location
8
Arms
13.6
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nicotine patch
  • Drug: Nicotine gum
  • Behavioral: Medication Therapy Management
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
2x2x2 factorial design2x2x2 factorial design
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Testing the Efficacy, Feasibility and Acceptability of a Pharmacist-Delivered Medication Therapy Management Approach to Smoking Cessation for Rural Smokers in Appalachia
Actual Study Start Date :
Aug 31, 2021
Actual Primary Completion Date :
Jun 27, 2022
Actual Study Completion Date :
Oct 19, 2022

Arms and Interventions

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:
  • Nicoderm CQ
  • nicotine transdermal system patch
  • Habitrol
  • 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:
  • Nicoderm CQ
  • nicotine transdermal system patch
  • Habitrol
  • 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:
  • Nicoderm CQ
  • nicotine transdermal system patch
  • Habitrol
  • 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:
  • Nicoderm CQ
  • nicotine transdermal system patch
  • Habitrol
  • 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:
  • Nicoderm CQ
  • nicotine transdermal system patch
  • Habitrol
  • 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:
  • Nicoderm CQ
  • nicotine transdermal system patch
  • Habitrol
  • 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:
  • Nicoderm CQ
  • nicotine transdermal system patch
  • Habitrol
  • 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:
  • Nicoderm CQ
  • nicotine transdermal system patch
  • Habitrol
  • Nicotrol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of recruitment [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 [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 [3 months]

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

    Secondary Outcome Measures

    1. Tobacco Use [3 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Virginia Charlottesville Virginia United States 22903

    Sponsors and Collaborators

    • University of Virginia

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Melissa Little, PhD, MPH, Associate Professor, Department of Public Health Sciences, University of Virginia
    ClinicalTrials.gov Identifier:
    NCT05649241
    Other Study ID Numbers:
    • HSR210262
    First Posted:
    Dec 14, 2022
    Last Update Posted:
    Dec 14, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Nicotine

    Study Results

    No Results Posted as of Dec 14, 2022