SmokingNCT05210699
CSD201201: Study to Assess Elements of Abuse Liability for Electronic Nicotine Delivery System P12
A study testing Product A, Product B and Product C in people with Smoking and Smoking Behaviors, run by RAI Services Company at 2 sites in United States.
Trial summary
This is a randomized, open-label, 6-way crossover, multi-site study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics [PD]), and nicotine uptake (pharmacokinetics [PK]) during and following ad libitum use of the Electronic Nicotine Delivery… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Behaviors, Tobacco Use
- 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
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Mar 2022to 17 May 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
- Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
- Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of consent.
- Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.
- Positive urine cotinine test at Screening.
- Smokes only combustible, filtered, menthol cigarettes, 83 mm to 100 mm in length.
- Agrees to smoke same usual brand (UB) cigarette throughout the study period. UB cigarette is defined as the cigarette brand style currently smoked most frequently by the subject.
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- Subjects must meet one (a or b) of the following tobacco use conditions:
- Smokes at least 10 cigarettes per day (on average) 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 Principal Investigator (PI).
- Dual user of combustible cigarettes and electronic cigarettes (ECs) who self-reports:
- Smoking at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening Visit. Brief periods of abstinence more than 30 days prior to screening due to illness, quit attempt or clinical study participation will be allowed at the discretion of the Investigator and ii. Using a nicotine-containing ENDS (cartridge or a tank system).
- 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."
- Willing to use UB cigarette, ENDS, and Nicorette gum during the study period.
- Willing to abstain from tobacco and nicotine use for at least 12 hours prior to each Test Session.
- Females must be willing to use a form of contraception acceptable to the PI from the time of signing informed consent until End-of-Study.
- Agrees to in-clinic confinement of 8 days and 7 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.
- 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.
- Weight of ≤ 110 pounds.
- Hemoglobin level is < 12.5 for females or <13.0 for males g/dL at Screening.
- 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.
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- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- 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.
- Must not be a current regular user (i.e., > 5 times per month) of any tobacco products other than CCs or ENDS within the last 6 months prior to screening.
- Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to the signing of informed consent.
- History or presence of bleeding or clotting disorders.
- Any use of anticoagulants or daily use of aspirin (≥ 325 mg).
- Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of informed consent and between Screening and check-in Day 1.
- Plasma donation within (≤) 7 days prior to the signing of informed consent and between Screening and check-in Day 1.
- Participation in another clinical trial within (≤) 30 days prior to the signing of 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 ICF in the current study.
- Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
- A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening or Day 1.
- Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or a previous quit attempt within (≤) 30 days prior to the signing of the ICF.
- Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol breathalyzer result at Screening or Day 1.
- Employed by a tobacco or nicotine company, the study site, or handles tobacco- or nicotine-containing products as part of their job.
- Determined by the PI to be inappropriate for this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
AMR Knoxville
Knoxville, Tennessee, 37920
QPS Bio-Kinetic
Springfield, Missouri, 65802
About this study
Official title: CSD201201: A Randomized, Open-Label, Crossover Study to Assess Elements of Abuse Liability for Electronic Nicotine Delivery System P12
This is a randomized, open-label, 6-way crossover, multi-site study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics [PD]), and nicotine uptake (pharmacokinetics [PK]) during and following ad libitum use of the Electronic Nicotine Delivery Systems (ENDS) investigational products (IPs) in generally healthy combustible cigarette (CC) smokers and dual users of CC and ENDS.
Read the detailed description
The study will evaluate elements of AL of ENDS IPs against CC and nicotine polacrilex gum in generally healthy menthol CC smokers of and dual users of CC and ENDS in a confinement setting.
Potential subjects will complete a pre-screening interview and a Screening Visit to assess eligibility within 45 days prior to enrollment, randomization and confinement.
Starting on Study Day 1, eligible subjects will be randomized to 1 of 6 IP use sequences (based on a Williams Design) and will be confined at the clinical site for 8 days and 7 nights to complete the study.
On Day 3 and continuing through Day 8, subjects in each arm will participate in six separate Test Sessions, one for each IP, that will last for approximately 4 hours following the start of IP use. During each Test Session, subjects will use one of the six IPs: four ENDS IPs, a high-AL comparator (subject's UB cigarette) and a low-AL comparator (a commercially available nicotine gum for nicotine replacement therapy), based on the assigned IP use sequences. ENDS IP cartridges will be weighed prior to and after product use in the Test Session. Each Test Session will include collection of both PD measures (subjective and physiological) and PK measures prior to, during, and following IP use.
Subjects will acclimate to the assigned products prior to each Test Session. On Study Day 1 (Pre-study Product Acclimation Period), subjects will use each of five IPs (four ENDS IPs and one nicotine gum) at least once. In addition, on the half day prior to each respective Test Session (Starting on Day 2), subjects will participate in a Product Acclimation Period in which they will use the randomized IP (to be tested during the following day's Test Session, to include ENDS or nicotine gum) at least four times . Subjects will have access to UB cigarette for ad libitum use at any time during Pre-Study Product Acclimation period and Product Acclimation Periods as long as they meet the IP acclimation criteria. At the end of each Product Acclimation Period, there will be a required 12-hour abstinence period from use of tobacco/nicotine containing products prior to the Test Session the following day. The study will complete when all six IPs have been tested.
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Being tested
- Product A, Product B, Product C, Product D, Product E
- 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, menthol combustible cigarette
Product BOther
Flavor variant P1211216 of a 1.5% nicotine ENDS product
Product COther
Flavor variant P1211217 of a 2.4% nicotine ENDS product
Product DOther
Flavor variant P1211222 of a 5.0% nicotine ENDS product
Product EOther
Flavor variant P1213616 of a 1.5% nicotine ENDS product
Product NOther
Nicorette® White Ice Mint 4 mg nicotine gum
| Study group | Role | What they receive |
|---|---|---|
| Product usage order A B N C E D | Experimental | Subjects will use each of the 5 products sequentially (A B N C E D) 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 N |
| Product usage order B C A D N E | Experimental | Subjects will use each of the 5 products sequentially (B C A D N E) 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 N |
| Product usage order C D B E A N | Experimental | Subjects will use each of the 5 products sequentially (C D B E A N) 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 N |
| Product usage order D E C N B A | Experimental | Subjects will use each of the 5 products sequentially (D E C N B A) 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 N |
| Product usage order E N D A C B | Experimental | Subjects will use each of the 5 products sequentially (E N D A C B) 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 N |
| Product usage order N A E B D C | Experimental | Subjects will use each of the 5 products sequentially (N A E B D C) 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 N |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUECPL 3-240
area-under-the-effects curve (AUEC) for product liking (PL) numeric rating scale (NRS) score-versus-time curve from 3 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) 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 posted27 Jan 2022
- Study start21 Mar 2022
- Primary completion17 May 2022
- Study completion17 May 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Hong, MD, Study director, RAIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210699
- Sponsor's protocol ID
- CSD201201
- Status last verified
- Jun 2022
- First submitted
- 13 Jan 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kanobe MN, Baxter SA, Prevette K, Jin T, Tapia MA, Ayoku S, Dull GM, Makena P, Mohrmann J, Keyser BM, Gale N, Jordan KG. Assessment of nicotine pharmacokinetics and abuse liability in randomized, crossover studies of Vuse Alto electronic nicotine delivery systems. Front Pharmacol. 2026 Jul 14;17:1796858. doi: 10.3389/fphar.2026.1796858. eCollection 2026.
PubMed 42523979
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSD201201: A Randomized, Open-Label, Crossover Study to Assess Elements of Abuse Liability for Electronic Nicotine Delivery System P12
- ClinicalTrials.gov ID
- NCT05210699
- Acronym / sponsor ID
- CSD201201
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 27 Jan 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.
This is a randomized, open-label, 6-way crossover, multi-site study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics [PD]), and nicotine uptake (pharmacokinetics [PK]) during and following ad libitum use of the Electronic Nicotine Delivery Systems (ENDS) investigational products (IPs) in generally healthy combustible cigarette (CC) smokers and dual users of CC and ENDS.
Detailed description
The study will evaluate elements of AL of ENDS IPs against CC and nicotine polacrilex gum in generally healthy menthol CC smokers of and dual users of CC and ENDS in a confinement setting.
Potential subjects will complete a pre-screening interview and a Screening Visit to assess eligibility within 45 days prior to enrollment, randomization and confinement.
Starting on Study Day 1, eligible subjects will be randomized to 1 of 6 IP use sequences (based on a Williams Design) and will be confined at the clinical site for 8 days and 7 nights to complete the study.
On Day 3 and continuing through Day 8, subjects in each arm will participate in six separate Test Sessions, one for each IP, that will last for approximately 4 hours following the start of IP use. During each Test Session, subjects will use one of the six IPs: four ENDS IPs, a high-AL comparator (subject's UB cigarette) and a low-AL comparator (a commercially available nicotine gum for nicotine replacement therapy), based on the assigned IP use sequences. ENDS IP cartridges will be weighed prior to and after product use in the Test Session. Each Test Session will include collection of both PD measures (subjective and physiological) and PK measures prior to, during, and following IP use.
Subjects will acclimate to the assigned products prior to each Test Session. On Study Day 1 (Pre-study Product Acclimation Period), subjects will use each of five IPs (four ENDS IPs and one nicotine gum) at least once. In addition, on the half day prior to each respective Test Session (Starting on Day 2), subjects will participate in a Product Acclimation Period in which they will use the randomized IP (to be tested during the following day's Test Session, to include ENDS or nicotine gum) at least four times . Subjects will have access to UB cigarette for ad libitum use at any time during Pre-Study Product Acclimation period and Product Acclimation Periods as long as they meet the IP acclimation criteria. At the end of each Product Acclimation Period, there will be a required 12-hour abstinence period from use of tobacco/nicotine containing products prior to the Test Session the following day. The study will complete when all six IPs have been tested.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Product usage order A B N C E D | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product NSubjects will use each of the 5 products sequentially (A B N C E D) during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order B C A D N E | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product NSubjects will use each of the 5 products sequentially (B C A D N E) during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order C D B E A N | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product NSubjects will use each of the 5 products sequentially (C D B E A N) during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order D E C N B A | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product NSubjects will use each of the 5 products sequentially (D E C N B A) during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order E N D A C B | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product NSubjects will use each of the 5 products sequentially (E N D A C B) during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order N A E B D C | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product NSubjects will use each of the 5 products sequentially (N A E B D C) 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 (15 listed)
- Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
- Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of consent.
- Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.
- Positive urine cotinine test at Screening.
- Smokes only combustible, filtered, menthol cigarettes, 83 mm to 100 mm in length.
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.
- 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.
- Weight of ≤ 110 pounds.
- Hemoglobin level is < 12.5 for females or <13.0 for males g/dL at Screening.
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 combustible cigarette | Other | Product usage order A B N C E D, Product usage order B C A D N E, Product usage order C D B E A N, Product usage order D E C N B A, Product usage order E N D A C B, Product usage order N A E B D C |
| Product BFlavor variant P1211216 of a 1.5% nicotine ENDS product | Other | Product usage order A B N C E D, Product usage order B C A D N E, Product usage order C D B E A N, Product usage order D E C N B A, Product usage order E N D A C B, Product usage order N A E B D C |
| Product CFlavor variant P1211217 of a 2.4% nicotine ENDS product | Other | Product usage order A B N C E D, Product usage order B C A D N E, Product usage order C D B E A N, Product usage order D E C N B A, Product usage order E N D A C B, Product usage order N A E B D C |
| Product DFlavor variant P1211222 of a 5.0% nicotine ENDS product | Other | Product usage order A B N C E D, Product usage order B C A D N E, Product usage order C D B E A N, Product usage order D E C N B A, Product usage order E N D A C B, Product usage order N A E B D C |
| Product EFlavor variant P1213616 of a 1.5% nicotine ENDS product | Other | Product usage order A B N C E D, Product usage order B C A D N E, Product usage order C D B E A N, Product usage order D E C N B A, Product usage order E N D A C B, Product usage order N A E B D C |
| Product NNicorette® White Ice Mint 4 mg nicotine gum | Other | Product usage order A B N C E D, Product usage order B C A D N E, Product usage order C D B E A N, Product usage order D E C N B A, Product usage order E N D A C B, Product usage order N A E B D C |
Primary outcome
AUECPL 3-240
Time frame: 5 minutes to 240 minutes
area-under-the-effects curve (AUEC) for product liking (PL) numeric rating scale (NRS) score-versus-time curve from 3 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
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 29 Jun 2022.
- Derived from this study: PubMed 42523979Kanobe MN, Baxter SA, Prevette K, Jin T, Tapia MA, Ayoku S, Dull GM, Makena P, Mohrmann J, Keyser BM, Gale N, Jordan KG. Assessment of nicotine pharmacokinetics and abuse liability in randomized, crossover studies of Vuse Alto electronic nicotine delivery systems. Front Pharmacol. 2026 Jul 14;17:1796858. doi: 10.3389/fphar.2026.1796858. eCollection 2026.
- 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.
Jason Hong, MD 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 Smoking Behaviors, 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 15 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 29 Jun 2022. 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 3-240 (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?
On the ClinicalTrials.gov record for NCT05210699, 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 29 Jun 2022.