SmokingNCT05129657
CSD201001: Study to Assess Elements of Abuse Liability for Three Nicotine Pouches
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, 5-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, Tobacco Smoking
- What is being tested?
- Product A, Product B and Product C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Nov 2021to 24 Jun 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. 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 PI.
- Smokers who also use ST products (e.g., moist snuff, snus), 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 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, 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 five Test Sessions.
- Females must be willing to use a form of contraception acceptable to the PI from the time of signing the informed consent until End-of-Study.
- Examples of acceptable means of birth control are, but not limited to:
- Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy);
- physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide;
- non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g., Mirena or Kyleena);
- vasectomized partner; and
- post-menopausal and not on hormone replacement therapy.
- Agrees to an in-clinic confinement of 6 days (5 nights).
Who cannot join
- 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 the PI, 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 the PI's discretion pending approval from the Medical Monitor.
- 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 and at check-in Day 1.
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- Weight of ≤ 110 pounds.
- Hemoglobin level is < 12.5 g/dL for females or < 13.0 for males g/dL at Screening.
- Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening or check-in Day 1.
- 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, estrogen-containing contraception or hormone replacement therapy.
- Whole blood donation 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 tobacco- or nicotine-containing products as part of their job.
- Participation in another clinical trial within (≤) 30 days prior to signing the informed consent. The 30-day window for each subject will be derived from the date of the last study event in the previous study to the time of signing the informed consent in the current study.
- Drinks more than 21 servings of alcoholic beverages per week.
- Has a positive alcohol result at Screening or check-in Day 1.
- Determined by the PI to be inappropriate for this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Elite Raleigh
Raleigh, North Carolina, 27612
ICON Clinical Research
San Antonio, Texas, 78209
About this study
Official title: An In-Clinic Confinement Study to Assess Elements of Abuse Liability for Three P10 Nicotine Pouches
This is a two-site, open-label, randomized, 5-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 and smokers also using smokeless tobacco products (ST) will be recruited into this AL study to evaluate elements of AL of three nicotine pouches compared to combustible cigarettes (CC) and nicotine polacrilex gum. At least one-third of the study population will include smokers who also use ST.
Potential subjects may complete a pre-screening telephone interview. Subjects will complete a Screening Visit to assess their eligibility within 45 days prior to check-in and enrollment.
Starting on Day 1, subjects will check-in at the clinical site to complete procedures to confirm eligibility. Eligible subjects will be enrolled and confined for 6 days. Subjects will be randomized to one of 10 product use sequences (using a Williams Design) in which the subjects will evaluate one IP in each of five separate Test Sessions, such that each subject will evaluate five IPs, including three IPs, 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 6, subjects will participate in Test Sessions that will last for approximately 4 hours. Each Test Session will include collection of both 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 randomized IP (at least two trial uses) for product familiarization prior to use in the next day's Test Session. Subjects can also use their UB cigarettes ad libitum, until the 12-hour tobacco abstinence begins prior to each Test Session, as long as the minimum use requirement for randomized IP is met.
- Conditions
- Smoking, Tobacco Use, Tobacco Smoking
- Being tested
- Product A, Product B, Product C, Product D, Product N
- Medical subject headings
- Smoking, Tobacco Use, Tobacco Smoking
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, non-menthol or menthol cigarette
Product BOther
P1012914, A nicotine pouch product with 4 mg of nicotine
Product COther
P1012915, A nicotine pouch product with 8 mg of nicotine
Product DOther
P1012919, A nicotine pouch product with 12 mg of nicotine
Product NOther
Nicorette® White Ice Mint 4 mg nicotine gum
| Study group | Role | What they receive |
|---|---|---|
| Product usage order ABCDN | Experimental | Subjects will use each of the 5 products sequentially (ABCDN) 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 N |
| Product usage order ACBND | Experimental | Subjects will use each of the 5 products sequentially (ACBND) 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 N |
| Product usage order BADCN | Experimental | Subjects will use each of the 5 products sequentially (BADCN) 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 N |
| Product usage order BDANC | Experimental | Subjects will use each of the 5 products sequentially (BDANC) 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 N |
| Product usage order CANBD | Experimental | Subjects will use each of the 5 products sequentially (CANBD) 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 N |
| Product usage order CNADB | Experimental | Subjects will use each of the 5 products sequentially (CNADB) 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 N |
| Product usage order DBNAC | Experimental | Subjects will use each of the 5 products sequentially (DBNAC) 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 N |
| Product usage order DNBCA | Experimental | Subjects will use each of the 5 products sequentially (DNBCA) 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 N |
| Product usage order NCDAB | Experimental | Subjects will use each of the 5 products sequentially (NCDAB) 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 N |
| Product usage order NDCBA | Experimental | Subjects will use each of the 5 products sequentially (NDCBA) 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 N |
What is being measured
The primary outcome is the main question the study is designed to answer.
(AUECPL) 5-240: area-under-the-effects curve (AUEC) for Product Liking (PL)
area-under-the-effects curve (AUEC) for PL numeric rating scale (NRS) score-versus-time curve from 5 minutes to 240 minutes after the start of IP use. Product Liking is a numeric rating scale ranging from 0 to 10. A higher score indicates a higher liking of the product.
Measured: 5 minutes to 240 minutes
Emax PL: Maximum product liking (PL)
Maximum product liking (PL) numeric rating scale (NRS) score after the start of IP use. Product Liking is a numeric rating scale ranging from 0 to 10. A higher score indicates a higher liking of the product.
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 posted22 Nov 2021
- Study start2 Nov 2021
- Primary completion24 Jun 2022
- Study completion24 Jun 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 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
- Milly Kanobe, PhD, Study director, RAIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129657
- Sponsor's protocol ID
- CSD201001
- Status last verified
- Jun 2022
- First submitted
- 29 Oct 2021
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kanobe MN, Powell CY, Patrudu M, Baxter SA, Tapia MA, Darnell J, Prevette K, Gibson AG, Ayoku SA, Campbell L, Coffield JW, Keyser BM, Ganesh BS, Gale N, Jordan KG. Randomized crossover clinical studies to assess abuse liability and nicotine pharmacokinetics of Velo Oral Nicotine pouches. Front Pharmacol. 2025 Mar 13;16:1547073. doi: 10.3389/fphar.2025.1547073. eCollection 2025.
PubMed 40183092
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. 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 Three P10 Nicotine Pouches
- ClinicalTrials.gov ID
- NCT05129657
- Acronym / sponsor ID
- CSD201001
- Conditions
- Smoking, Tobacco Use, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 22 Nov 2021 (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, 5-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 and smokers also using smokeless tobacco products (ST) will be recruited into this AL study to evaluate elements of AL of three nicotine pouches compared to combustible cigarettes (CC) and nicotine polacrilex gum. At least one-third of the study population will include smokers who also use ST.
Potential subjects may complete a pre-screening telephone interview. Subjects will complete a Screening Visit to assess their eligibility within 45 days prior to check-in and enrollment.
Starting on Day 1, subjects will check-in at the clinical site to complete procedures to confirm eligibility. Eligible subjects will be enrolled and confined for 6 days. Subjects will be randomized to one of 10 product use sequences (using a Williams Design) in which the subjects will evaluate one IP in each of five separate Test Sessions, such that each subject will evaluate five IPs, including three IPs, 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 6, subjects will participate in Test Sessions that will last for approximately 4 hours. Each Test Session will include collection of both 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 randomized IP (at least two trial uses) for product familiarization prior to use in the next day's Test Session. Subjects can also use their UB cigarettes ad libitum, until the 12-hour tobacco abstinence 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
- 10
| Arm | Type | Receives |
|---|---|---|
| Product usage order ABCDN | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product NSubjects will use each of the 5 products sequentially (ABCDN) during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order ACBND | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product NSubjects will use each of the 5 products sequentially (ACBND) during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order BADCN | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product NSubjects will use each of the 5 products sequentially (BADCN) during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order BDANC | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product NSubjects will use each of the 5 products sequentially (BDANC) during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order CANBD | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product NSubjects will use each of the 5 products sequentially (CANBD) during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order CNADB | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product NSubjects will use each of the 5 products sequentially (CNADB) during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order DBNAC | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product NSubjects will use each of the 5 products sequentially (DBNAC) during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order DNBCA | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product NSubjects will use each of the 5 products sequentially (DNBCA) during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order NCDAB | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product NSubjects will use each of the 5 products sequentially (NCDAB) during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order NDCBA | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product NSubjects will use each of the 5 products sequentially (NDCBA) 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 (19 listed)
- 1. 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 PI.
- Smokers who also use ST products (e.g., moist snuff, snus), and have used ST within 30 days prior to screening, will be enrolled.
Key exclusion criteria (22 listed)
- 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 the PI, 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 the PI's discretion pending approval from the Medical Monitor.
- 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.
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, non-menthol or menthol cigarette | Other | Product usage order ABCDN, Product usage order ACBND, Product usage order BADCN, Product usage order BDANC, Product usage order CANBD, Product usage order CNADB, Product usage order DBNAC, Product usage order DNBCA, Product usage order NCDAB, Product usage order NDCBA |
| Product BP1012914, A nicotine pouch product with 4 mg of nicotine | Other | Product usage order ABCDN, Product usage order ACBND, Product usage order BADCN, Product usage order BDANC, Product usage order CANBD, Product usage order CNADB, Product usage order DBNAC, Product usage order DNBCA, Product usage order NCDAB, Product usage order NDCBA |
| Product CP1012915, A nicotine pouch product with 8 mg of nicotine | Other | Product usage order ABCDN, Product usage order ACBND, Product usage order BADCN, Product usage order BDANC, Product usage order CANBD, Product usage order CNADB, Product usage order DBNAC, Product usage order DNBCA, Product usage order NCDAB, Product usage order NDCBA |
| Product DP1012919, A nicotine pouch product with 12 mg of nicotine | Other | Product usage order ABCDN, Product usage order ACBND, Product usage order BADCN, Product usage order BDANC, Product usage order CANBD, Product usage order CNADB, Product usage order DBNAC, Product usage order DNBCA, Product usage order NCDAB, Product usage order NDCBA |
| Product NNicorette® White Ice Mint 4 mg nicotine gum | Other | Product usage order ABCDN, Product usage order ACBND, Product usage order BADCN, Product usage order BDANC, Product usage order CANBD, Product usage order CNADB, Product usage order DBNAC, Product usage order DNBCA, Product usage order NCDAB, Product usage order NDCBA |
Primary outcome
(AUECPL) 5-240: area-under-the-effects curve (AUEC) for Product Liking (PL)
Time frame: 5 minutes to 240 minutes
area-under-the-effects curve (AUEC) for PL numeric rating scale (NRS) score-versus-time curve from 5 minutes to 240 minutes after the start of IP use. Product Liking is a numeric rating scale ranging from 0 to 10. A higher score indicates a higher liking of the product.
Emax PL: Maximum product liking (PL)
Time frame: 240 minutes
Maximum product liking (PL) numeric rating scale (NRS) score after the start of IP use. Product Liking is a numeric rating scale ranging from 0 to 10. A higher score indicates a higher liking of the product.
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 30 Apr 2024.
- Derived from this study: PubMed 40183092Kanobe MN, Powell CY, Patrudu M, Baxter SA, Tapia MA, Darnell J, Prevette K, Gibson AG, Ayoku SA, Campbell L, Coffield JW, Keyser BM, Ganesh BS, Gale N, Jordan KG. Randomized crossover clinical studies to assess abuse liability and nicotine pharmacokinetics of Velo Oral Nicotine pouches. Front Pharmacol. 2025 Mar 13;16:1547073. doi: 10.3389/fphar.2025.1547073. eCollection 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.
Milly Kanobe, PhD study director
RAIS
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 19 inclusion and 22 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 30 Apr 2024. 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: area-under-the-effects curve (AUEC) for Product Liking (PL) (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?
On the ClinicalTrials.gov record for NCT05129657, 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 30 Apr 2024; AzTrials last refreshed its copy on 1 Nov 2026.