Tobacco Use CessationNCT06161675
Feasibility of Delivering VergeRx at FQHCs
A study testing QuitAid, SmokefreeTXT and Nicotine Replacement Therapy Patch in people with Tobacco Use Cessation, run by University of Virginia at 1 site in United States.
Trial summary
Cigarette smoking in the U.S. is highest among low income and Medicaid insured adults, and unfortunately, low-income smokers are even less likely to attempt to quit, less likely to use evidence-based treatments, and thus less likely to be successful. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- QuitAid, SmokefreeTXT and Nicotine Replacement Therapy Patch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- patient at participating Federally Qualified Health Center
- ≥18 years of age
- able to read, speak, and understand English
- report smoking ≥5 cigarettes per day for the past 6 months
- own a cell phone
- be willing and able to use NRT in the form of patch or lozenge
- not be pregnant or planning to be pregnant in the next 6 months
Who cannot join
- have a medical contraindication to NRT (e.g., past 30 days, heart attack or stroke; past 6 months, serious or worsening angina, very rapid or irregular heartbeat requiring medication)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: Determining the Feasibility of Delivering VergeRx to Smokers Through Pharmacies in Federally Qualified Health Centers Regardless of Readiness to Quit
Cigarette smoking in the U.S. is highest among low income and Medicaid insured adults, and unfortunately, low-income smokers are even less likely to attempt to quit, less likely to use evidence-based treatments, and thus less likely to be successful. Federally Qualified Health Centers (FQHCs), which generally provide healthcare services to low income and Medicaid insured patients, are more likely to serve individuals who use tobacco and are required to report tobacco use screening rates and their delivery of cessation interventions. Thus, FQHCs are an ideal community-partner to reach low-income smokers, particularly smokers who are not currently seeking treatment. To address this gap, the investigators developed a pharmacist-delivered smoking cessation intervention to help facilitate nicotine replacement therapy medication adherence among smokers. The proposed study aims to examine the feasibility of delivering the pharmacist-delivered smoking cessation intervention to FQHC patients who are ready to quit, and expanding the intervention for smokers not ready to quit by adding 2 pre-quit sessions focused on rate reduction. The investigators will also determine facilitators and barriers to adopting and implementing the program in FQHCs.
Read the detailed description
Cigarette smoking in the U.S. is highest among low income and Medicaid insured adults, and unfortunately, low-income smokers are even less likely to attempt to quit, less likely to use evidence-based treatments, and thus less likely to be successful. Federally Qualified Health Centers (FQHCs), which generally provide healthcare to low income and Medicaid insured patients, are more likely to serve individuals who use tobacco, and are required to report tobacco use screening rates and deliver cessation interventions. Thus, FQHCs are an ideal community-partner to reach low-income smokers. The investigators developed a pharmacist-delivered medication management program for smoking cessation to help facilitate nicotine replacement therapy medication adherence, and the investigators piloted the program in a rural Appalachian community pharmacy and found that the intervention was acceptable and feasible to pharmacists and smokers. The investigators are currently testing the effectiveness of the intervention along with standard, evidence-based tobacco treatments among rural smokers in Appalachia with a pharmacist-delivered approach in a R01 funded by NCI (R01CA267963, PI Little). However, given the low-income population served by FQHCs, there are likely unique barriers to smoking cessation in this setting. The investigators examined tobacco cessation services at pharmacies within FQHCs as well as potential barriers and facilitators to implementing a QuitAid program in this setting. The investigators found that only 43.5% provided smoking cessation to patients, and these services were limited to help seeking only smokers who were ready to quit. Thus, an opportunity exists to utilize pharmacists at FQHCs to maximize the reach of smoking cessation interventions, to both smokers ready to quit and those who are not yet ready to quit. The proposed study builds logically on this preliminary work by examining the feasibility of delivering a pharmacist-delivered medication management program for smoking cessation to FQHC patients who are ready to quit, and expanding this research for smokers who are not ready to quit by adding 2 pre-quit sessions focused on Rate Reduction (RR). Thus, the aims of the current study are: (1) Determine the feasibility of implementing a pharmacist-delivered medication management program for smoking cessation for smokers ready to quit and for smokers not ready to quit in FQHC pharmacies; and (2) Use an implementation science approach to determine facilitators and barriers to adopting and implementing a pharmacist delivered smoking cessation program in FQHCs. The proposed work will provide foundational evidence for a larger trial to determine the efficacy of these interventions.
- Conditions
- Tobacco Use Cessation
- Being tested
- QuitAid, SmokefreeTXT, Nicotine Replacement Therapy Patch, Nicotine lozenge
- Keywords
- Federally Qualified Health Center, Rural, Appalachia, Smoking Cessation, Readiness to Quit, Pharmacists, Pharmacies, Low Income, Medicaid
- Medical subject headings
- Tobacco Use Cessation, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuitAidBehavioural
Also called Medication Therapy Management (MTM)
Participants will receive the QuitAid intervention, based on a medication adherence intervention, which addresses perceptions (e.g., motivation, self-efficacy, beliefs) and practicalities of using NRT (e.g., monitoring NRT use, establishing a reminder system). QuitAid includes 1 in-person session and 5 follow-up telephonic sessions with the participant's local pharmacist/technician. Smokers not ready to quit will receive up to two sessions focused on using NRT to cut down cigarette use. If a smoker decides they are ready to quit at the 2- or 4-week follow-ups, they will receive the full QuitAid intervention.
SmokefreeTXTBehavioural
All participants will receive the SmokefreeTXT is a text-messaging program offered through the National Cancer Institute's Smokefree.gov initiative, which sends pre-programmed messages timed around a quit date. Participants will receive 3-5 messages a day for 7 weeks. The first week of messages focus on preparation and the remaining 6 weeks of messages focus on post-cessation strategies (e.g., relapse prevention), all timed relative to the quit date set at enrollment. For smokers not ready to quit, participants will receive two week-long pre-quit modules, Practice Quit and Daily Challenges. These modules will help the smoker become comfortable with not smoking for short periods of time and build skills before they attempt to quit. If a smoker decides they are ready to quit at the 2- or 4-week follow-ups, they will receive the ready to quit treatment.
Nicotine Replacement Therapy PatchDrug
Also called Nicotrol Transdermal Product, Nicoderm C-Q Transdermal Product, Lucy Transdermal Product, Pixotine Transdermal Product
All participants will receive up to 8 weeks of NRT in the form of patch. At the 4-week follow-up, all participants still smoking will be offered an additional 4 weeks of NRT, regardless of readiness to quit. NRT temporarily replaces nicotine from tobacco to reduce motivation to consume tobacco and nicotine withdrawal symptoms.
Nicotine lozengeDrug
Also called Sunmark Nicotine Polacrilex Lozenge, Habitrol Nicotine Lozenge, Nicotinell Nicotine Lozenge, Nicorette Lozenge
All participants will receive up to 8 weeks of NRT in the form of lozenge. At the 4-week follow-up, all participants still smoking will be offered an additional 4 weeks of NRT, regardless of readiness to quit. NRT temporarily replaces nicotine from tobacco to reduce motivation to consume tobacco and nicotine withdrawal symptoms.
| Study group | Role | What they receive |
|---|---|---|
| QuitAid + SmokefreeTXT + NRT (Patch + Lozenge) | Experimental | Participants will receive QuitAid, a medication therapy management delivered by their pharmacist, a texting intervention to help quit smoking, and up to 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch + lozenge. Receives: Behavioral: QuitAid; Behavioral: SmokefreeTXT; Drug: Nicotine Replacement Therapy Patch; Drug: Nicotine lozenge |
| SmokefreeTXT + NRT (Patch + Lozenge) | Active comparator | Participants will receive a texting intervention to help quit smoking and up to 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch + lozenge. Receives: Behavioral: SmokefreeTXT; Drug: Nicotine Replacement Therapy Patch; Drug: Nicotine lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment
Measured by (a) the proportion of smokers recruited from each source (e.g., ask-advise-prescribe, posters, prescription bag advertisements) and (b) the number of smokers recruited per month.
Measured: 6 months
Feasibility of Randomization
Determine the number of smokers that will needed to be approached and screened in order to randomize 100 smokers (e.g., ineligible smokers, smokers that do not consent) in six months across two FQHCs.
Measured: 6 months
Feasibility of Retention
Assessment of the proportion of smokers who complete the 12-week follow-up.
Measured: 12 weeks
Dose of the MTM intervention
Dose of the MTM intervention will be defined at the number of MTM sessions the participant received as documented in the REDCap database by the pharmacists.
Measured: 12 weeks
Dose of the NRT
Dose of NRT will be defined as the percent of NRT used and will be collected from participants at the follow-ups.
Measured: 12 weeks
Dose of SmokefreeTXT
Dose of SmokefreeTXT will be defined by the use of keywords, responses to the within-program assessment questions, and date of SmokefreeTXT opt out (i.e., texted "STOP", if applicable).
Measured: 12 weeks
Secondary outcomes (2)
Biochemical Verification of Tobacco Abstinence by Participants
The investigators will assess self-reported point prevalence abstinence defined as not smoking (even a puff) within the past seven days. If a participant reports no tobacco use in the previous 7-days at the at the 12-week follow-up point, we will ask them to go into their FQHC pharmacy where their pharmacist will biochemically verify their abstinence using Microport Smokelyzer carbon monoxide monitors within 48 hours. We will consider cutoff in the range of 3-4 ppm for carbon monoxide as viable cutoff to determine abstinence in their saliva to be smokers; this liberal definition will avoid false positives due to secondhand smoke. Lower results will indicate if smoking cessation treatment has been effective.
Measured: 12 weeks
Quit Attempts
The number of times that participants have made a quit attempt since the previous contact at the 2-, 4-, 8- and 12-week follow-ups via electronic survey. A "quit attempt" will be defined as cigarette abstinence for ≥ 24 hours not due to involuntary or forced cessation (i.e., hospitalization). Lower results will indicate if smoking cessation treatment has been effective.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start23 Sep 2024
- Primary completion31 Jan 2025
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Participants will be randomized via computerized block design after consenting to the study. Equal allocation across treatment combinations will be used and balance between treatment combinations will be maintained by use of randomly permutated blocks. The randomization is not blinded, the study team will know what conditions each subject is randomized to. The randomization schemes will be generated using the R statistical package and will be incorporated into the REDCap database prior to initiation of the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
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 A Little, PhD,MPH, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161675
- Sponsor's protocol ID
- HSR 230207
- Status last verified
- Oct 2025
- First submitted
- 8 Sep 2023
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data Management System. This study will use REDCap electronic data capture tools hosted at the University of Virginia. The database will be hosted on secure, HIPAA-compliant UVA computing servers and its access will be restricted to authorized individuals.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Feasibility of Delivering VergeRx to Smokers Through Pharmacies in Federally Qualified Health Centers Regardless of Readiness to Quit
- ClinicalTrials.gov ID
- NCT06161675
- Acronym / sponsor ID
- HSR 230207
- Conditions
- Tobacco Use Cessation
- Keywords
- Federally Qualified Health Center, Rural, Appalachia, Smoking Cessation, Readiness to Quit, Pharmacists, Pharmacies, Low Income
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 8 Dec 2023 (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.
Cigarette smoking in the U.S. is highest among low income and Medicaid insured adults, and unfortunately, low-income smokers are even less likely to attempt to quit, less likely to use evidence-based treatments, and thus less likely to be successful. Federally Qualified Health Centers (FQHCs), which generally provide healthcare services to low income and Medicaid insured patients, are more likely to serve individuals who use tobacco and are required to report tobacco use screening rates and their delivery of cessation interventions. Thus, FQHCs are an ideal community-partner to reach low-income smokers, particularly smokers who are not currently seeking treatment. To address this gap, the investigators developed a pharmacist-delivered smoking cessation intervention to help facilitate nicotine replacement therapy medication adherence among smokers. The proposed study aims to examine the feasibility of delivering the pharmacist-delivered smoking cessation intervention to FQHC patients who are ready to quit, and expanding the intervention for smokers not ready to quit by adding 2 pre-quit sessions focused on rate reduction. The investigators will also determine facilitators and barriers to adopting and implementing the program in FQHCs.
Detailed description
Cigarette smoking in the U.S. is highest among low income and Medicaid insured adults, and unfortunately, low-income smokers are even less likely to attempt to quit, less likely to use evidence-based treatments, and thus less likely to be successful. Federally Qualified Health Centers (FQHCs), which generally provide healthcare to low income and Medicaid insured patients, are more likely to serve individuals who use tobacco, and are required to report tobacco use screening rates and deliver cessation interventions. Thus, FQHCs are an ideal community-partner to reach low-income smokers. The investigators developed a pharmacist-delivered medication management program for smoking cessation to help facilitate nicotine replacement therapy medication adherence, and the investigators piloted the program in a rural Appalachian community pharmacy and found that the intervention was acceptable and feasible to pharmacists and smokers. The investigators are currently testing the effectiveness of the intervention along with standard, evidence-based tobacco treatments among rural smokers in Appalachia with a pharmacist-delivered approach in a R01 funded by NCI (R01CA267963, PI Little). However, given the low-income population served by FQHCs, there are likely unique barriers to smoking cessation in this setting. The investigators examined tobacco cessation services at pharmacies within FQHCs as well as potential barriers and facilitators to implementing a QuitAid program in this setting. The investigators found that only 43.5% provided smoking cessation to patients, and these services were limited to help seeking only smokers who were ready to quit. Thus, an opportunity exists to utilize pharmacists at FQHCs to maximize the reach of smoking cessation interventions, to both smokers ready to quit and those who are not yet ready to quit. The proposed study builds logically on this preliminary work by examining the feasibility of delivering a pharmacist-delivered medication management program for smoking cessation to FQHC patients who are ready to quit, and expanding this research for smokers who are not ready to quit by adding 2 pre-quit sessions focused on Rate Reduction (RR). Thus, the aims of the current study are: (1) Determine the feasibility of implementing a pharmacist-delivered medication management program for smoking cessation for smokers ready to quit and for smokers not ready to quit in FQHC pharmacies; and (2) Use an implementation science approach to determine facilitators and barriers to adopting and implementing a pharmacist delivered smoking cessation program in FQHCs. The proposed work will provide foundational evidence for a larger trial to determine the efficacy of these interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized via computerized block design after consenting to the study. Equal allocation across treatment combinations will be used and balance between treatment combinations will be maintained by use of randomly permutated blocks. The randomization is not blinded, the study team will know what conditions each subject is randomized to. The randomization schemes will be generated using the R statistical package and will be incorporated into the REDCap database prior to initiation of the study.
| Arm | Type | Receives |
|---|---|---|
| QuitAid + SmokefreeTXT + NRT (Patch + Lozenge) | Experimental | Behavioral: QuitAid, Behavioral: SmokefreeTXT, Drug: Nicotine Replacement Therapy Patch, Drug: Nicotine lozengeParticipants will receive QuitAid, a medication therapy management delivered by their pharmacist, a texting intervention to help quit smoking, and up to 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch + lozenge. |
| SmokefreeTXT + NRT (Patch + Lozenge) | Active comparator | Behavioral: SmokefreeTXT, Drug: Nicotine Replacement Therapy Patch, Drug: Nicotine lozengeParticipants will receive a texting intervention to help quit smoking and up to 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch + lozenge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patient at participating Federally Qualified Health Center
- ≥18 years of age
- able to read, speak, and understand English
- report smoking ≥5 cigarettes per day for the past 6 months
- own a cell phone
Key exclusion criteria (1 listed)
- have a medical contraindication to NRT (e.g., past 30 days, heart attack or stroke; past 6 months, serious or worsening angina, very rapid or irregular heartbeat requiring medication)
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 |
|---|---|---|
| QuitAidAlso: Medication Therapy Management (MTM)Participants will receive the QuitAid intervention, based on a medication adherence intervention, which addresses perceptions (e.g., motivation, self-efficacy, beliefs) and practicalities of using NRT (e.g., monitoring NRT use, establishing a reminder system). QuitAid includes 1 in-person session and 5 follow-up telephonic sessions with the participant's local pharmacist/technician. Smokers not ready to quit will receive up to two sessions focused on using NRT to cut down cigarette use. If a smoker decides they are ready to quit at the 2- or 4-week follow-ups, they will receive the full QuitAid intervention. | Behavioural | QuitAid + SmokefreeTXT + NRT (Patch + Lozenge) |
| SmokefreeTXTAll participants will receive the SmokefreeTXT is a text-messaging program offered through the National Cancer Institute's Smokefree.gov initiative, which sends pre-programmed messages timed around a quit date. Participants will receive 3-5 messages a day for 7 weeks. The first week of messages focus on preparation and the remaining 6 weeks of messages focus on post-cessation strategies (e.g., relapse prevention), all timed relative to the quit date set at enrollment. For smokers not ready to quit, participants will receive two week-long pre-quit modules, Practice Quit and Daily Challenges. These modules will help the smoker become comfortable with not smoking for short periods of time and build skills before they attempt to quit. If a smoker decides they are ready to quit at the 2- or 4-week follow-ups, they will receive the ready to quit treatment. | Behavioural | QuitAid + SmokefreeTXT + NRT (Patch + Lozenge), SmokefreeTXT + NRT (Patch + Lozenge) |
| Nicotine Replacement Therapy PatchAlso: Nicotrol Transdermal Product, Nicoderm C-Q Transdermal Product, Lucy Transdermal Product, Pixotine Transdermal ProductAll participants will receive up to 8 weeks of NRT in the form of patch. At the 4-week follow-up, all participants still smoking will be offered an additional 4 weeks of NRT, regardless of readiness to quit. NRT temporarily replaces nicotine from tobacco to reduce motivation to consume tobacco and nicotine withdrawal symptoms. | Drug | QuitAid + SmokefreeTXT + NRT (Patch + Lozenge), SmokefreeTXT + NRT (Patch + Lozenge) |
| Nicotine lozengeAlso: Sunmark Nicotine Polacrilex Lozenge, Habitrol Nicotine Lozenge, Nicotinell Nicotine Lozenge, Nicorette LozengeAll participants will receive up to 8 weeks of NRT in the form of lozenge. At the 4-week follow-up, all participants still smoking will be offered an additional 4 weeks of NRT, regardless of readiness to quit. NRT temporarily replaces nicotine from tobacco to reduce motivation to consume tobacco and nicotine withdrawal symptoms. | Drug | QuitAid + SmokefreeTXT + NRT (Patch + Lozenge), SmokefreeTXT + NRT (Patch + Lozenge) |
Primary outcome
Feasibility of Recruitment
Time frame: 6 months
Measured by (a) the proportion of smokers recruited from each source (e.g., ask-advise-prescribe, posters, prescription bag advertisements) and (b) the number of smokers recruited per month.
Feasibility of Randomization
Time frame: 6 months
Determine the number of smokers that will needed to be approached and screened in order to randomize 100 smokers (e.g., ineligible smokers, smokers that do not consent) in six months across two FQHCs.
Feasibility of Retention
Time frame: 12 weeks
Assessment of the proportion of smokers who complete the 12-week follow-up.
Dose of the MTM intervention
Time frame: 12 weeks
Dose of the MTM intervention will be defined at the number of MTM sessions the participant received as documented in the REDCap database by the pharmacists.
Dose of the NRT
Time frame: 12 weeks
Dose of NRT will be defined as the percent of NRT used and will be collected from participants at the follow-ups.
Dose of SmokefreeTXT
Time frame: 12 weeks
Dose of SmokefreeTXT will be defined by the use of keywords, responses to the within-program assessment questions, and date of SmokefreeTXT opt out (i.e., texted "STOP", if applicable).
2 secondary outcomes
Biochemical Verification of Tobacco Abstinence by Participants
Time frame: 12 weeks
Quit Attempts
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: No. Data Management System. This study will use REDCap electronic data capture tools hosted at the University of Virginia. The database will be hosted on secure, HIPAA-compliant UVA computing servers and its access will be restricted to authorized individuals.
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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 A Little, PhD,MPH 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 QuitAid, SmokefreeTXT and Nicotine Replacement Therapy Patch in people with Tobacco Use 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 7 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
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: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.