SmokingNCT06777784
Modern Nicotine Oral Product Abuse Liability
A study testing Product A, Product B and Product C in people with Smoking and Tobacco Use, run by RAI Services Company at 2 sites in United States.
Trial summary
This is a two-site, open-label, randomized, 8-way cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics [PD]) and plasma nicotine uptake (pharmacokinetics [PK]) during and following ad libitum use of the study investigational… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco Use
- What is being tested?
- Product A, Product B and Product C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Feb 2025to 5 Mar 2025
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
- Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of consent.
- Smokes combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as primary source of tobacco.
- Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the an investigator.
- Smokers who also use ST products (e.g., moist snuff, snus, modern oral), and have used ST within 30 days prior to screening, will be enrolled.
- Agrees to smoke the same UB cigarette throughout the study period. The UB cigarette is defined as the reported cigarette brand and style currently smoked most frequently by the subject.
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- Expired breath carbon monoxide (ECO) level is ≥ 10 ppm and ≤ 100 ppm at Screening and at check-in (Day -1).
- Positive urine cotinine test (e.g., >200 ng/mL) via dipstick at Screening.
- Response at Screening to the Fagerström Test for Nicotine Dependence (FTND) Question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "6-30 minutes" (Heatherton et al., 1991).
- Willing to use the UB cigarette, Velo PLUS IPs, and Nicorette® nicotine gum during the study period.
- Willing to abstain from tobacco and nicotine use for at least 12 hours prior to the start of each of eight Test Sessions.
- Females must be willing to use a form of contraception acceptable to an investigator from the time of signing the ICF until End-of-Study. Examples of acceptable means of birth control are, but not limited to: a) Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy); b) physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide; c) non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g., Mirena or Kyleena); d) vasectomized partner; or e) post-menopausal and not on hormone replacement therapy.
- Agrees to an in-clinic confinement of ten days (nine nights).
Who cannot join
- Allergic to or cannot tolerate mint or wintergreen flavoring agents.
- Individuals or their family members that have ongoing litigation with tobacco company(ies)
- Have used electronic nicotine delivery system (e.g., Vuse Alto, JUUL) or tobacco heating device (e.g., iQOS) within the last 30 days prior to screening.
- Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of an investigator, makes the study subject unsuitable to participate in this clinical study.
- History, presence of, or clinical laboratory test results indicating diabetes.
- Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at an investigator discretion.
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- History or presence of bleeding or clotting disorders.
- Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes at Screening or at check-in Day -1.
- Weight of ≤ 110 pounds at screening or at check-in.
- Hemoglobin level is < 12.5 g/dL for females or < 13.0 g/dL for males at Screening.
- Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- Has positive urine drug screen (UDS) or alcohol test (urine or breath) at Screening or at Check-in to the Assessment Phase (Day -1), with the exception of positive results for tetrahydrocannabinol (THC). If positive for THC at check-in (Day -1), a cannabis intoxication evaluation will be performed, and inclusion will be at the discretion of an investigator.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV).
- Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to signing the informed consent.
- Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or self-reports a previous quit attempt within (≤) 30 days prior to signing the informed consent.
- Any use of daily aspirin (≥ 325 mg) or any use of other anticoagulants.
- Individuals ≥ 35 years of age currently using systemic, testosterone, estrogen-containing contraception or hormone replacement therapy.
- Whole blood donation or lost blood or blood products in excess of 500 mL within 8 weeks (≤ 56 days) prior to signing the informed consent and between Screening and check-in Day -1.
- Plasma donation within (≤) 7 days prior to signing the informed consent and between Screening and check-in Day -1.
- Employed by a tobacco or nicotine company, the study site, or handles raw, unpackaged tobacco- or nicotine-containing products as part of their job.
- Has used an investigational drug, device, biologic, or tobacco/nicotine product in a previous clinical study within 30 days or 5 times the half-life of the product (whichever is longer) prior to Screening.
- Drinks more than 21 servings of alcoholic beverages per week.
- Determined by an investigator to be inappropriate for this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
AMR Knoxville
Knoxville, Tennessee, 37920
AMR Lexington
Lexington, Kentucky, 40509
About this study
Official title: An In-Clinic Confinement Study to Assess Elements of Abuse Liability for Six Modern Nicotine Oral Products
This is a two-site, open-label, randomized, 8-way cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics [PD]) and plasma nicotine uptake (pharmacokinetics [PK]) during and following ad libitum use of the study investigational products (IPs) by generally healthy smokers.
Read the detailed description
Cigarette smokers naïve to smokeless tobacco products (ST) and smokers also using ST will be recruited into this AL study to evaluate elements of AL of six modern oral nicotine products compared to combustible cigarettes (CC) and nicotine polacrilex gum. An attempt will be made for at least one-third of the study population to include smokers using ST.
Potential subjects will complete a pre-screening telephone interview. They will complete a Screening Visit to assess their eligibility within 45 days prior to check-in and enrollment.
Starting on check in day (Day -1), subjects will check-in at the clinical site to complete procedures to confirm eligibility. Eligible subjects will be enrolled, randomized and confined for 10 days (9 nights). Prior to the first product acclimation period, subjects will conduct a product familiarization of three of the modern oral nicotine products. Subjects will be randomized to one of eight product use sequences (using a Williams Design) in which they will evaluate one IP in each of eight separate Test Sessions, such that each subject will evaluate eight IPs, including six modern oral nicotine products, and both a high-AL comparator (subject's usual brand [UB] cigarette) and a low-AL comparator (a commercially available nicotine replacement therapy [NRT] nicotine gum).
On Day 2 and continuing through Day 9, subjects will participate in Test Sessions that will last approximately 4 hours. Each Test Session will include collection of both types of PD measures (subjective and physiological) and PK measures prior to, during, and following IP use.
On the half day prior to each respective Test Session, a Product Acclimation Period will allow subjects ad libitum use of the subsequent IP (at least two trial uses) as per randomized sequence for product acclimation prior to use in the next day's Test Session. Subjects can also use their UB cigarettes ad libitum, until the 12-hour tobacco and nicotine abstinence period begins prior to each Test Session, as long as the minimum use requirement for randomized IP is met.
- Conditions
- Smoking, Tobacco Use
- Being tested
- Product A, Product B, Product C, Product D, Product E
- Medical subject headings
- Smoking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product AOther
Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette
Product BOther
Modern Nicotine Oral Product Cool Mint 6 mg Nicotine
Product COther
Modern Nicotine Oral Product Cool Mint 12 mg Nicotine
Product DOther
Modern Nicotine Oral Product Cool Mint 15 mg Nicotine
Product EOther
Modern Nicotine Oral Product Smooth 6 mg Nicotine
Product FOther
Modern Nicotine Oral Product Wintergreen 6 mg Nicotine
Product GOther
Modern Nicotine Oral Product Dragon Fruit 6 mg Nicotine
Product NOther
Nicorette® White Ice Mint 4 mg nicotine gum
| Study group | Role | What they receive |
|---|---|---|
| Product usage order ANBGCFDE | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product N |
| Product usage order BACNDGEF | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product N |
| Product usage order CBDAENFG | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product N |
| Product usage order DCEBFAGN | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product N |
| Product usage order EDFCGBNA | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product N |
| Product usage order FEGDNCAB | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product N |
| Product usage order GFNEADBC | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product N |
| Product usage order NGAFBECD | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product N |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUECPL 5-240
area under the effect curve (AUEC) for PL (VAS score-versus-time)
Measured: 5 minutes to 240 minutes
Emax PL
maximum effect (maximum PL VAS score after the start of IP use)
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start3 Feb 2025
- Primary completion5 Mar 2025
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by RAI Services CompanyThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Keyser, PhD, Study director, Reynolds American
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777784
- Sponsor's protocol ID
- CSD241801
- Status last verified
- Dec 2025
- First submitted
- 10 Jan 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In-Clinic Confinement Study to Assess Elements of Abuse Liability for Six Modern Nicotine Oral Products
- ClinicalTrials.gov ID
- NCT06777784
- Acronym / sponsor ID
- CSD241801
- Conditions
- Smoking, Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 16 Jan 2025 (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.
This is a two-site, open-label, randomized, 8-way cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics [PD]) and plasma nicotine uptake (pharmacokinetics [PK]) during and following ad libitum use of the study investigational products (IPs) by generally healthy smokers.
Detailed description
Cigarette smokers naïve to smokeless tobacco products (ST) and smokers also using ST will be recruited into this AL study to evaluate elements of AL of six modern oral nicotine products compared to combustible cigarettes (CC) and nicotine polacrilex gum. An attempt will be made for at least one-third of the study population to include smokers using ST.
Potential subjects will complete a pre-screening telephone interview. They will complete a Screening Visit to assess their eligibility within 45 days prior to check-in and enrollment.
Starting on check in day (Day -1), subjects will check-in at the clinical site to complete procedures to confirm eligibility. Eligible subjects will be enrolled, randomized and confined for 10 days (9 nights). Prior to the first product acclimation period, subjects will conduct a product familiarization of three of the modern oral nicotine products. Subjects will be randomized to one of eight product use sequences (using a Williams Design) in which they will evaluate one IP in each of eight separate Test Sessions, such that each subject will evaluate eight IPs, including six modern oral nicotine products, and both a high-AL comparator (subject's usual brand [UB] cigarette) and a low-AL comparator (a commercially available nicotine replacement therapy [NRT] nicotine gum).
On Day 2 and continuing through Day 9, subjects will participate in Test Sessions that will last approximately 4 hours. Each Test Session will include collection of both types of PD measures (subjective and physiological) and PK measures prior to, during, and following IP use.
On the half day prior to each respective Test Session, a Product Acclimation Period will allow subjects ad libitum use of the subsequent IP (at least two trial uses) as per randomized sequence for product acclimation prior to use in the next day's Test Session. Subjects can also use their UB cigarettes ad libitum, until the 12-hour tobacco and nicotine abstinence period begins prior to each Test Session, as long as the minimum use requirement for randomized IP is met.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Product usage order ANBGCFDE | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product NSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session |
| Product usage order BACNDGEF | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product NSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session |
| Product usage order CBDAENFG | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product NSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session |
| Product usage order DCEBFAGN | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product NSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session |
| Product usage order EDFCGBNA | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product NSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session |
| Product usage order FEGDNCAB | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product NSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session |
| Product usage order GFNEADBC | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product NSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session |
| Product usage order NGAFBECD | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product NSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
- Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of consent.
- Smokes combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as primary source of tobacco.
- Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the an investigator.
- Smokers who also use ST products (e.g., moist snuff, snus, modern oral), and have used ST within 30 days prior to screening, will be enrolled.
Key exclusion criteria (24 listed)
- Allergic to or cannot tolerate mint or wintergreen flavoring agents.
- Individuals or their family members that have ongoing litigation with tobacco company(ies)
- Have used electronic nicotine delivery system (e.g., Vuse Alto, JUUL) or tobacco heating device (e.g., iQOS) within the last 30 days prior to screening.
- Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of an investigator, makes the study subject unsuitable to participate in this clinical study.
- History, presence of, or clinical laboratory test results indicating diabetes.
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 |
|---|---|---|
| Product AUsual Brand (UB) filtered, menthol or non-menthol combustible cigarette | Other | Product usage order ANBGCFDE, Product usage order BACNDGEF, Product usage order CBDAENFG, Product usage order DCEBFAGN, Product usage order EDFCGBNA, Product usage order FEGDNCAB, Product usage order GFNEADBC, Product usage order NGAFBECD |
| Product BModern Nicotine Oral Product Cool Mint 6 mg Nicotine | Other | Product usage order ANBGCFDE, Product usage order BACNDGEF, Product usage order CBDAENFG, Product usage order DCEBFAGN, Product usage order EDFCGBNA, Product usage order FEGDNCAB, Product usage order GFNEADBC, Product usage order NGAFBECD |
| Product CModern Nicotine Oral Product Cool Mint 12 mg Nicotine | Other | Product usage order ANBGCFDE, Product usage order BACNDGEF, Product usage order CBDAENFG, Product usage order DCEBFAGN, Product usage order EDFCGBNA, Product usage order FEGDNCAB, Product usage order GFNEADBC, Product usage order NGAFBECD |
| Product DModern Nicotine Oral Product Cool Mint 15 mg Nicotine | Other | Product usage order ANBGCFDE, Product usage order BACNDGEF, Product usage order CBDAENFG, Product usage order DCEBFAGN, Product usage order EDFCGBNA, Product usage order FEGDNCAB, Product usage order GFNEADBC, Product usage order NGAFBECD |
| Product EModern Nicotine Oral Product Smooth 6 mg Nicotine | Other | Product usage order ANBGCFDE, Product usage order BACNDGEF, Product usage order CBDAENFG, Product usage order DCEBFAGN, Product usage order EDFCGBNA, Product usage order FEGDNCAB, Product usage order GFNEADBC, Product usage order NGAFBECD |
| Product FModern Nicotine Oral Product Wintergreen 6 mg Nicotine | Other | Product usage order ANBGCFDE, Product usage order BACNDGEF, Product usage order CBDAENFG, Product usage order DCEBFAGN, Product usage order EDFCGBNA, Product usage order FEGDNCAB, Product usage order GFNEADBC, Product usage order NGAFBECD |
| Product GModern Nicotine Oral Product Dragon Fruit 6 mg Nicotine | Other | Product usage order ANBGCFDE, Product usage order BACNDGEF, Product usage order CBDAENFG, Product usage order DCEBFAGN, Product usage order EDFCGBNA, Product usage order FEGDNCAB, Product usage order GFNEADBC, Product usage order NGAFBECD |
| Product NNicorette® White Ice Mint 4 mg nicotine gum | Other | Product usage order ANBGCFDE, Product usage order BACNDGEF, Product usage order CBDAENFG, Product usage order DCEBFAGN, Product usage order EDFCGBNA, Product usage order FEGDNCAB, Product usage order GFNEADBC, Product usage order NGAFBECD |
Primary outcome
AUECPL 5-240
Time frame: 5 minutes to 240 minutes
area under the effect curve (AUEC) for PL (VAS score-versus-time)
Emax PL
Time frame: 240 minutes
maximum effect (maximum PL VAS score after the start of IP use)
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 23 Dec 2025.
- 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.
Brian Keyser, PhD study director
Reynolds American
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Product A, Product B and Product C in people with Smoking and Tobacco Use, run by RAI Services Company at 2 sites 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 13 inclusion and 24 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
AUECPL 5-240 (time frame: 5 minutes to 240 minutes). The study lists 2 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 23 Dec 2025.