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QuitAid Pilot Feasibility Trial

NCT ID: NCT05649241

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2022-10-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2x2x2 factorial design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Nicotine patch

Intervention Type DRUG

Nicotine replacement therapy patch

Nicotine gum

Intervention Type DRUG

Nicotine replacement therapy gum

Medication Therapy Management

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Nicotine patch

Intervention Type DRUG

Nicotine replacement therapy patch

Nicotine gum

Intervention Type DRUG

Nicotine replacement therapy gum

Medication Therapy Management

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Nicotine patch

Intervention Type DRUG

Nicotine replacement therapy patch

Medication Therapy Management

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Nicotine patch

Intervention Type DRUG

Nicotine replacement therapy patch

Medication Therapy Management

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Nicotine patch

Intervention Type DRUG

Nicotine replacement therapy patch

Nicotine gum

Intervention Type DRUG

Nicotine replacement therapy gum

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

Group Type EXPERIMENTAL

Nicotine patch

Intervention Type DRUG

Nicotine replacement therapy patch

Nicotine gum

Intervention Type DRUG

Nicotine replacement therapy gum

No QuitAid, 8 weeks, Patch

Participants received 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch

Group Type EXPERIMENTAL

Nicotine patch

Intervention Type DRUG

Nicotine replacement therapy patch

No QuitAid, 4 weeks, Patch

Participants received 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch

Group Type EXPERIMENTAL

Nicotine patch

Intervention Type DRUG

Nicotine replacement therapy patch

Interventions

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Nicotine patch

Nicotine replacement therapy patch

Intervention Type DRUG

Nicotine gum

Nicotine replacement therapy gum

Intervention Type DRUG

Medication Therapy Management

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Nicoderm CQ nicotine transdermal system patch Habitrol Nicotrol nicorette lucy habitrol pixotine QuitAid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Melissa Little, PhD, MPH

Associate Professor, Department of Public Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melissa Little, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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Little MA, Reid T, Moncrief M, Cohn W, Wiseman KP, Wood CH, You W, Anderson RT, Krukowski RA. Testing the feasibility of the QuitAid smoking cessation intervention in a randomized factorial design in an independent, rural community pharmacy. Pilot Feasibility Stud. 2024 Feb 26;10(1):41. doi: 10.1186/s40814-024-01465-9.

Reference Type DERIVED
PMID: 38409089 (View on PubMed)

Other Identifiers

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HSR210262

Identifier Type: -

Identifier Source: org_study_id