Smoking CessationNCT05649241
QuitAid Pilot Feasibility Trial
A study testing Nicotine patch, Nicotine gum and Medication Therapy Management in people with Smoking Cessation, run by University of Virginia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine patch, Nicotine gum and Medication Therapy Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2021to 19 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: Testing the Efficacy, Feasibility and Acceptability of a Pharmacist-Delivered Medication Therapy Management Approach to Smoking Cessation for Rural Smokers in Appalachia
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine patch, Nicotine gum, Medication Therapy Management
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
Also called Nicoderm CQ, nicotine transdermal system patch, Habitrol, Nicotrol
Nicotine replacement therapy patch
Nicotine gumDrug
Also called nicorette, lucy, habitrol, pixotine
Nicotine replacement therapy gum
Medication Therapy ManagementBehavioural
Also called QuitAid
Medication therapy management delivered by pharmacist - 1 in-person coaching session, and 5 follow-up telephonic coaching sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Nicotine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 3 months
Retention
Retention was assessed by the proportion of smokers who completed the 3-month follow-up.
Measured: 3 months
Secondary outcomes (1)
Tobacco Use
Biochemically verified self-reported point prevalence tobacco abstinence at the 3-month follow-up was collected
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start31 Aug 2021
- Primary completion27 Jun 2022
- Study completion19 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2x2 factorial design
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Little, PhD, MPH, University of Virginia
- Investigators
- Melissa Little, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649241
- Sponsor's protocol ID
- HSR210262
- Status last verified
- Dec 2022
- First submitted
- 4 Dec 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38409089
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy, Feasibility and Acceptability of a Pharmacist-Delivered Medication Therapy Management Approach to Smoking Cessation for Rural Smokers in Appalachia
- ClinicalTrials.gov ID
- NCT05649241
- Acronym / sponsor ID
- HSR210262
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- 2x2x2 factorial design
| Arm | Type | Receives |
|---|---|---|
| QuitAid, 8 weeks, Patch + Gum | Experimental | Drug: Nicotine patch, Drug: Nicotine gum, Behavioral: Medication Therapy ManagementParticipants 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 | Experimental | Drug: Nicotine patch, Drug: Nicotine gum, Behavioral: Medication Therapy ManagementParticipants 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 | Experimental | Drug: Nicotine patch, Behavioral: Medication Therapy ManagementParticipants 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 |
| QuitAid, 4 weeks, Patch | Experimental | Drug: Nicotine patch, Behavioral: Medication Therapy ManagementParticipants 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 | Experimental | Drug: Nicotine patch, Drug: Nicotine gumParticipants received 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum |
| No QuitAid, 4 weeks, Patch + Gum | Experimental | Drug: Nicotine patch, Drug: Nicotine gumParticipants received 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum |
| No QuitAid, 8 weeks, Patch | Experimental | Drug: Nicotine patchParticipants received 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch |
| No QuitAid, 4 weeks, Patch | Experimental | Drug: Nicotine patchParticipants received 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine patchAlso: Nicoderm CQ, nicotine transdermal system patch, Habitrol, NicotrolNicotine replacement therapy patch | Drug | 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 gumAlso: nicorette, lucy, habitrol, pixotineNicotine replacement therapy gum | Drug | No QuitAid, 4 weeks, Patch + Gum, No QuitAid, 8 weeks, Patch + Gum, QuitAid, 4 weeks, Patch + Gum, QuitAid, 8 weeks, Patch + Gum |
| Medication Therapy ManagementAlso: QuitAidMedication therapy management delivered by pharmacist - 1 in-person coaching session, and 5 follow-up telephonic coaching sessions. | Behavioural | QuitAid, 4 weeks, Patch, QuitAid, 4 weeks, Patch + Gum, QuitAid, 8 weeks, Patch, QuitAid, 8 weeks, Patch + Gum |
Primary outcome
Feasibility of recruitment
Time frame: 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
Time frame: 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).
Retention
Time frame: 3 months
Retention was assessed by the proportion of smokers who completed the 3-month follow-up.
1 secondary outcome
Tobacco Use
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Derived from this study: PubMed 38409089Little 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Little, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine patch, Nicotine gum and Medication Therapy Management in people with Smoking Cessation, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05649241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.