QuitAid Pilot Feasibility Trial

NCT05649241 | Completed DMC

• 1 other identifier: HSR210262
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Retention

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

  3 months

Secondary Outcomes (1)

• Tobacco Use

  3 months

Study Arms (8)

QuitAid, 8 weeks, Patch + Gum

EXPERIMENTAL

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; Drug: Nicotine gum; Behavioral: Medication Therapy Management

QuitAid, 4 weeks, Patch + Gum

EXPERIMENTAL

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; Drug: Nicotine gum; Behavioral: Medication Therapy Management

QuitAid, 8 weeks, Patch

EXPERIMENTAL

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; Behavioral: Medication Therapy Management

QuitAid, 4 weeks, Patch

EXPERIMENTAL

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; Behavioral: Medication Therapy Management

No QuitAid, 8 weeks, Patch + Gum

EXPERIMENTAL

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

Drug: Nicotine patch; Drug: Nicotine gum

No QuitAid, 4 weeks, Patch + Gum

EXPERIMENTAL

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

Drug: Nicotine patch; Drug: Nicotine gum

No QuitAid, 8 weeks, Patch

EXPERIMENTAL

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

Drug: Nicotine patch

No QuitAid, 4 weeks, Patch

EXPERIMENTAL

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

Drug: Nicotine patch

Interventions

Nicotine patch DRUG

Nicotine replacement therapy patch

Also known as: Nicoderm CQ, nicotine transdermal system patch, Habitrol, Nicotrol

No QuitAid, 4 weeks, Patch; No QuitAid, 4 weeks, Patch + Gum; No QuitAid, 8 weeks, Patch; No QuitAid, 8 weeks, Patch + Gum; QuitAid, 4 weeks, Patch; QuitAid, 4 weeks, Patch + Gum; QuitAid, 8 weeks, Patch; QuitAid, 8 weeks, Patch + Gum

Nicotine gum DRUG

Nicotine replacement therapy gum

Also known as: nicorette, lucy, habitrol, pixotine

No QuitAid, 4 weeks, Patch + Gum; No QuitAid, 8 weeks, Patch + Gum; QuitAid, 4 weeks, Patch + Gum; QuitAid, 8 weeks, Patch + Gum

Medication Therapy Management BEHAVIORAL

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

Also known as: QuitAid

QuitAid, 4 weeks, Patch; QuitAid, 4 weeks, Patch + Gum; QuitAid, 8 weeks, Patch; QuitAid, 8 weeks, Patch + Gum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• 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.

  PMID: 38409089 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation Devices; Nicotine; Nicotine Chewing Gum; Medication Therapy Management

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration

Study Officials

• Melissa Little, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Public Health Sciences

Model Details: 2x2x2 factorial design

Study Record Dates

• First Submitted: December 4, 2022
• First Posted: December 14, 2022
• Study Start: August 31, 2021
• Primary Completion: June 27, 2022
• Study Completion: October 19, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)