SmokingNCT05114863
CSD200907: A Study to Assess Elements of Abuse Liability for a Heated Tobacco Product With Four Non-Combusted Cigarette Variants
A study testing Product A1, Product B and Product C in people with Smoking and Smoking Behaviors, run by RAI Services Company at 1 site in United States.
Trial summary
This is a single-center, open-label, randomized, 2-arm, within-arm 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… 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 A1, Product B and Product C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2021to 27 Feb 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 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. Smokers that also use other tobacco products (e.g., ENDS, smokeless tobacco, heated tobacco products) will not be excluded from study participation.
- 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.
- Agrees to smoke the same UB cigarette throughout the study period. The UB cigarette is defined as the reported cigarette brand style currently smoked most frequently by the subject.
- Expired breath carbon monoxide (ECO) level is ≥ 10 ppm and ≤ 100 ppm at Screening and at check-in Day 1.
Show all 12Show fewer
- 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".
- Willing to use UB cigarette, HTP 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 Test Session (either 5 or 6 sessions depending on the Study Arm).
- 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.
- Agrees to an in-clinic confinement of 11 days (10 nights) for Study Arm 1 -or- 13 days (12 nights) for Study Arm 2.
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.
Show all 22Show fewer
- 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 nicotine replacement therapy (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to signing the ICF.
- Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or self-reports a previous attempt within (≤) 30 days prior to signing the ICF.
- Any use of aspirin (≥ 325 mg/day) or 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 ICF. NOTE: Subjects will be advised against scheduling a whole blood donation for at least 7 days following study completion.
- Plasma donation within (≤) 7 days prior to signing the ICF. NOTE: Subjects will be advised against scheduling a plasma donation for at least 7 days following study completion.
- 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 ICF 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
1 site in 1 country.
About this study
Official title: An In-Clinic Confinement Study to Assess Elements of Abuse Liability for a Heated Tobacco Product (20020064) With Four Non-Combusted Cigarette Variants (40007385 - 40007388)
This is a single-center, open-label, randomized, 2-arm, within-arm 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
Smokers of both non-menthol and menthol combustible cigarettes (CC) will be recruited into this AL study to evaluate elements of AL of four heated tobacco products (HTP) (hereinafter, HTP investigational products [IPs]) compared to combustible cigarette (CC) and nicotine polacrilex gum.
Potential subjects may complete a pre-screening telephone interview. They will complete a Screening Visit to assess their eligibility within 45 days prior to check-in (inclusive of enrollment/randomization) and to determine their assignment to either Study Arm 1 (non-menthol smokers) or Study Arm 2 (menthol smokers). Enrollment and clinical conduct for each of the two Study Arms will occur sequentially.
Starting on Day 1, subjects will check-in at the study site to complete procedures to confirm eligibility. Eligible subjects will be enrolled into the appropriate Study Arm and confined for either 11 days (Study Arm 1) or 13 days (Study Arm 2). Based on their Study Arm assignment, subjects will be randomized to a product use sequence (using a Williams Design) in which they will evaluate one IP in each Test Session, including 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). In addition to the AL-comparators, Study Arm 1 will evaluate three HTP IPs (i.e., 5 Test Sessions) and Study Arm 2 will evaluate four HTP IPs (i.e., 6 Test Sessions).
On Day 1 and continuing through Day 11 (Study Arm 1) or Day 13 (Study Arm 2), 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.
There will be a 1.5-day Product Acclimation Period prior to each Test Session. During the Product Acclimation Period, subjects will be permitted ad libitum use of randomized IP for familiarization prior to use in the next Test Session, as well as ad libitum smoking of their UB cigarettes.
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Being tested
- Product A1, Product B, Product C, Product D, Product A2
- 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 A1Other
Usual Brand (UB) filtered, non-menthol cigarette
Product BOther
40007388, A Non-Combusted Cigarette Variant and product use Mode A
Product COther
40007388, A Non-Combusted Cigarette Variant and product use Mode B
Product DOther
40007386, A Non-Combusted Cigarette Variant and product use Mode B
Product A2Other
Usual Brand (UB) filtered, menthol cigarette
Product EOther
40007385, A Non-Combusted Cigarette Variant and product use Mode A
Product FOther
40007385, A Non-Combusted Cigarette Variant and product use Mode B
Product GOther
40007387, A Non-Combusted Cigarette Variant and product use Mode B
Product HOther
40007386, A Non-Combusted Cigarette Variant and product use Mode B
Product NOther
Nicorette® White Ice Mint 4 mg nicotine gum
| Study group | Role | What they receive |
|---|---|---|
| Non-menthol smokers | Experimental | Subjects will be randomized to one of ten product use sequences, such that one of the five IPs (A1,B,C,D,N) will be used in each of the five Test Sessions. Receives: Other: Product A1; Other: Product B; Other: Product C; Other: Product D; Other: Product N |
| Menthol smokers | Experimental | Subjects will be randomized to one of six product use sequences, such that one of the six IPs (A2,E,F,G,H,N) will be used in each of the six Test Sessions. Receives: Other: Product A2; Other: Product E; Other: Product F; Other: Product G; Other: Product H; 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 PL numeric rating scale (NRS) score-versus-time curve from 5 minutes to 240 minutes after the start of IP use.
Measured: 5 minutes to 240 minutes
Emax PL
maximum product liking (PL) numeric rating scale (NRS) 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 posted10 Nov 2021
- Study start29 Nov 2021
- Primary completion27 Feb 2022
- Study completion27 Feb 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
- 75 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
- NCT05114863
- Sponsor's protocol ID
- CSD200907
- Status last verified
- Jun 2022
- First submitted
- 29 Oct 2021
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kanobe MN, Makena P, Prevette K, Baxter SA. Assessment of Abuse Liability and Nicotine Pharmacokinetics of glo Heated Tobacco Products in a Randomized, Crossover Study. Eur J Drug Metab Pharmacokinet. 2024 Nov;49(6):733-750. doi: 10.1007/s13318-024-00921-4. Epub 2024 Oct 25.
PubMed 39453550
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. 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 a Heated Tobacco Product (20020064) With Four Non-Combusted Cigarette Variants (40007385 - 40007388)
- ClinicalTrials.gov ID
- NCT05114863
- Acronym / sponsor ID
- CSD200907
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 27 Feb 2022 (actual)
- Study completion
- 27 Feb 2022 (actual)
- First posted
- 10 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 single-center, open-label, randomized, 2-arm, within-arm 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
Smokers of both non-menthol and menthol combustible cigarettes (CC) will be recruited into this AL study to evaluate elements of AL of four heated tobacco products (HTP) (hereinafter, HTP investigational products [IPs]) compared to combustible cigarette (CC) and nicotine polacrilex gum.
Potential subjects may complete a pre-screening telephone interview. They will complete a Screening Visit to assess their eligibility within 45 days prior to check-in (inclusive of enrollment/randomization) and to determine their assignment to either Study Arm 1 (non-menthol smokers) or Study Arm 2 (menthol smokers). Enrollment and clinical conduct for each of the two Study Arms will occur sequentially.
Starting on Day 1, subjects will check-in at the study site to complete procedures to confirm eligibility. Eligible subjects will be enrolled into the appropriate Study Arm and confined for either 11 days (Study Arm 1) or 13 days (Study Arm 2). Based on their Study Arm assignment, subjects will be randomized to a product use sequence (using a Williams Design) in which they will evaluate one IP in each Test Session, including 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). In addition to the AL-comparators, Study Arm 1 will evaluate three HTP IPs (i.e., 5 Test Sessions) and Study Arm 2 will evaluate four HTP IPs (i.e., 6 Test Sessions).
On Day 1 and continuing through Day 11 (Study Arm 1) or Day 13 (Study Arm 2), 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.
There will be a 1.5-day Product Acclimation Period prior to each Test Session. During the Product Acclimation Period, subjects will be permitted ad libitum use of randomized IP for familiarization prior to use in the next Test Session, as well as ad libitum smoking of their UB cigarettes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-menthol smokers | Experimental | Other: Product A1, Other: Product B, Other: Product C, Other: Product D, Other: Product NSubjects will be randomized to one of ten product use sequences, such that one of the five IPs (A1,B,C,D,N) will be used in each of the five Test Sessions. |
| Menthol smokers | Experimental | Other: Product A2, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product NSubjects will be randomized to one of six product use sequences, such that one of the six IPs (A2,E,F,G,H,N) will be used in each of the six Test Sessions. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 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. Smokers that also use other tobacco products (e.g., ENDS, smokeless tobacco, heated tobacco products) will not be excluded from study participation.
- 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.
- Agrees to smoke the same UB cigarette throughout the study period. The UB cigarette is defined as the reported cigarette brand style currently smoked most frequently by the subject.
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 A1Usual Brand (UB) filtered, non-menthol cigarette | Other | Non-menthol smokers |
| Product B40007388, A Non-Combusted Cigarette Variant and product use Mode A | Other | Non-menthol smokers |
| Product C40007388, A Non-Combusted Cigarette Variant and product use Mode B | Other | Non-menthol smokers |
| Product D40007386, A Non-Combusted Cigarette Variant and product use Mode B | Other | Non-menthol smokers |
| Product A2Usual Brand (UB) filtered, menthol cigarette | Other | Menthol smokers |
| Product E40007385, A Non-Combusted Cigarette Variant and product use Mode A | Other | Menthol smokers |
| Product F40007385, A Non-Combusted Cigarette Variant and product use Mode B | Other | Menthol smokers |
| Product G40007387, A Non-Combusted Cigarette Variant and product use Mode B | Other | Menthol smokers |
| Product H40007386, A Non-Combusted Cigarette Variant and product use Mode B | Other | Menthol smokers |
| Product NNicorette® White Ice Mint 4 mg nicotine gum | Other | Menthol smokers, Non-menthol smokers |
Primary outcome
AUECPL 5-240
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.
Emax PL
Time frame: 240 minutes
maximum product liking (PL) numeric rating scale (NRS) 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 27 Jun 2022.
- Derived from this study: PubMed 39453550Kanobe MN, Makena P, Prevette K, Baxter SA. Assessment of Abuse Liability and Nicotine Pharmacokinetics of glo Heated Tobacco Products in a Randomized, Crossover Study. Eur J Drug Metab Pharmacokinet. 2024 Nov;49(6):733-750. doi: 10.1007/s13318-024-00921-4. Epub 2024 Oct 25.
- Individual participant dataSharing planned: No
Related trials for Smoking
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Recruiting
Communicating About Nicotine Reduction in Cigarettes
Tobacco Products, Smoking Behavior
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Product A1, Product B and Product C in people with Smoking and Smoking Behaviors, run by RAI Services Company 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 12 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 27 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 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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?
On the ClinicalTrials.gov record for NCT05114863, 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 27 Jun 2022.