QuitAid Pilot Feasibility Trial
- Conditions
- Smoking Cessation
- Interventions
- Registration Number
- NCT05649241
- Lead Sponsor
- University of Virginia
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description QuitAid, 4 weeks, Patch + Gum Nicotine 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 and the NRT Gum No QuitAid, 4 weeks, Patch + Gum Nicotine gum Participants received 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum No QuitAid, 4 weeks, Patch Nicotine patch Participants received 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch QuitAid, 8 weeks, Patch + Gum Nicotine 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 and the NRT Gum QuitAid, 8 weeks, Patch + Gum Medication Therapy Management 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 QuitAid, 4 weeks, Patch + Gum Nicotine 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 QuitAid, 4 weeks, Patch + Gum Medication Therapy Management 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 QuitAid, 8 weeks, Patch + Gum Nicotine 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 QuitAid, 8 weeks, Patch Nicotine 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 No QuitAid, 8 weeks, Patch + Gum Nicotine gum Participants received 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum QuitAid, 8 weeks, Patch Medication Therapy Management 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 No QuitAid, 4 weeks, Patch + Gum Nicotine patch Participants received 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum No QuitAid, 8 weeks, Patch Nicotine patch Participants received 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch QuitAid, 4 weeks, Patch Nicotine 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 QuitAid, 4 weeks, Patch Medication Therapy Management 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 No QuitAid, 8 weeks, Patch + Gum Nicotine patch Participants received 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum
- Primary Outcome Measures
Name Time Method Retention 3 months Retention was assessed by the proportion of smokers who completed the 3-month follow-up.
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.
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).
- Secondary Outcome Measures
Name Time Method Tobacco Use 3 months Biochemically verified self-reported point prevalence tobacco abstinence at the 3-month follow-up was collected
Trial Locations
- Locations (1)
University of Virginia
🇺🇸Charlottesville, Virginia, United States