QuitAid Pilot Feasibility Trial

University of Virginia

Status: Completed

Conditions: Smoking Cessation

Treatments: Drug: Nicotine patch; Drug: Nicotine gum; Behavioral: Medication Therapy Management

Study type: Interventional

Funder types: Other

Identifiers

NCT05649241

HSR210262

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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24 participants in 8 patient groups

QuitAid, 8 weeks, Patch + Gum

Experimental group

Description:

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

Treatment:

Behavioral: Medication Therapy Management

Drug: Nicotine gum

Drug: Nicotine patch

QuitAid, 4 weeks, Patch + Gum

Experimental group

Description:

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

Treatment:

Behavioral: Medication Therapy Management

Drug: Nicotine gum

Drug: Nicotine patch

QuitAid, 8 weeks, Patch

Experimental group

Description:

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

Treatment:

Behavioral: Medication Therapy Management

Drug: Nicotine patch

QuitAid, 4 weeks, Patch

Experimental group

Description:

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

Treatment:

Behavioral: Medication Therapy Management

Drug: Nicotine patch

No QuitAid, 8 weeks, Patch + Gum

Experimental group

Description:

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

Treatment:

Drug: Nicotine gum

Drug: Nicotine patch

No QuitAid, 4 weeks, Patch + Gum

Experimental group

Description:

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

Treatment:

Drug: Nicotine gum

Drug: Nicotine patch

No QuitAid, 8 weeks, Patch

Experimental group

Description:

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

Treatment:

Drug: Nicotine patch

No QuitAid, 4 weeks, Patch

Experimental group

Description:

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

Treatment:

Drug: Nicotine patch