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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05649241
Other study ID # HSR210262
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 31, 2021
Est. completion date October 19, 2022

Study information

Verified date December 2022
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date October 19, 2022
Est. primary completion date June 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Nicotine patch
Nicotine replacement therapy patch
Nicotine gum
Nicotine replacement therapy gum
Behavioral:
Medication Therapy Management
Medication therapy management delivered by pharmacist - 1 in-person coaching session, and 5 follow-up telephonic coaching sessions.

Locations

Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of recruitment 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
Primary Feasibility of randomization 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
Primary Retention Retention was assessed by the proportion of smokers who completed the 3-month follow-up. 3 months
Secondary Tobacco Use Biochemically verified self-reported point prevalence tobacco abstinence at the 3-month follow-up was collected 3 months
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