Tobacco UsePhase 1NCT03559725
Evaluation of Abuse Liability of Very Low Nicotine (VLN) Mentholated Cigarettes
A Phase 1 study testing VLN menthol cigarettes (A), Usual Brand Menthol Cigarettes (B) and Nicotine gum (C) in people with Tobacco Use, run by 22nd Century Group, Inc. at 1 site in United States.
Trial summary
This study is designed to evaluate the abuse liability of mentholated very low nicotine cigarettes compared to nicotine gum and usual brand cigarettes. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- VLN menthol cigarettes (A), Usual Brand Menthol Cigarettes (B) and Nicotine gum (C)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 4 Oct 2018
- Phase
- Phase 1
- 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 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be required to meet each one of the following inclusion criteria in order to be eligible for participation in the study:
- Must provide written informed consent prior to the initiation of any protocol-specific procedures.
- Male and female adults, between 22 to 65 years of age, inclusive.
- Body mass index (BMI) within 18.0 to 35.0 kg/m2, inclusive (minimum weight of at least 50.0 kg at Screening).
- Healthy, as determined by no clinically significant medical history, physical examination, 12-lead ECG, vital signs or laboratory (including hematology, clinical chemistry, urinalysis, and serology) findings at Screening, as judged by an investigator.
- Smoking history of an average of at least 10 manufactured filtered standard (i.e., not slim) king size combustible cigarettes daily for at least 1 year prior to Screening. Brief periods (i.e., up to 7 consecutive days) of non-smoking during the 3 months prior to Screening (e.g., due to illness or participation in a study where smoking was prohibited) will be permitted.
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- Self-reporting of desire to smoke within approximately 30 minutes of waking.
- Positive urine cotinine (≥500 ng/mL) at Screening.
- Negative pregnancy test at Screening and Day -1 (check-in) for all female subjects.
- Female subjects of non-childbearing potential must be surgically sterile or 1 year postmenopausal (as confirmed by serum Follicle Stimulating Hormone (FSH) > 35 U/L). A subject is considered to be surgically sterile if she has had a tubal ligation, hysterectomy, bilateral salpingo-oophorectomy or bilateral oophorectomy, or hysterectomy with bilateral salpingo-oophorectomy. If the subject is of childbearing potential, she must be using a medically accepted method of contraception and agree to continued use of this method for the duration of the study and for 30 days after completion of the study. Acceptable methods of contraception include abstinence, birth control pill, or an intrauterine device (known to have a failure rate of less than 1% per year) or double barrier method of contraception (e.g., male condom in addition to a diaphragm, contraceptive sponge or spermicide).
- Able to speak, read, and understand English sufficiently to allow completion of all study assessments.
- Must be willing to comply with the requirements and restrictions of the study.
Who cannot join
- Subjects will not be eligible to participate in this study if any one of the following exclusion criteria is met:
- Inability to tolerate 4 mg nicotine polacrilex gum during product use trial on Day -1 (check-in) or dentition prevents subjects from chewing gum.
- History or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease at Screening, which in the opinion of an investigator would jeopardize the safety of the subject or the validity of the study results.
- History or presence of any type of malignant tumors.
- Clinically significant abnormal findings on the vital signs, physical examination (including oral exam), medical history, or clinical laboratory results, in the opinion of an investigator.
- Positive serology test results for human immunodeficiency virus (HIV-1/HIV-2) Antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C Antibody (HCVAb).
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- An acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 2 weeks prior to Day -1 (check-in).
- Drug or alcohol abuse or dependence within the 24 months prior to Screening (except nicotine), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revision (DSM-IV-TR), or any self-reported dependence or "addiction" within the subject's lifetime (except nicotine or caffeine).
- Subjects who have ever been in treatment for substance use disorder(s) or who are currently
- Positive urine drug screen (UDS) or urine alcohol test at Screening or Day -1 (check-in).
- History or any current conditions that may interfere with drug absorption, distribution, metabolism, or excretion.
- History of severe allergic reaction (including anaphylaxis) to any substance, or previous status asthmaticus, or food allergies/intolerances/restrictions, or special dietary needs which, in the judgment of an investigator, contraindicates the subject's participation in the study.
- Requires concomitant treatment with prescription or non-prescription products that contain pseudoephedrine (e.g., nasal/sinus decongestants).
- Self-reported use of nicotine polacrilex gum, or other nicotine replacement therapy products in the 30 days prior to Day -1 (check-in). Isolated incidents within 30 days prior to Day -1 (check-in) may be permitted at the discretion of the investigator.
- Subject has unsuitable or difficult venous access or is unwilling or unable to undergo direct venipuncture or catheter insertion.
- Subject has donated or lost 100 to 499 mL whole blood within 30 days or more than 499 mL whole blood within 56 days preceding entry into the Confined Assessment Phase.
- Subject is an employee of the sponsor or research site personnel directly affiliated with this study or their immediate family member defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- Subject is lactating and or breast feeding.
- A subject who, in the opinion of an investigator, is considered unsuitable or unlikely to comply with the study protocol for any reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince and Associates Clinical Research, Inc
Overland Park, Kansas, 66212
About this study
Official title: Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Mentholated Cigarettes With Characterization of Nicotine Exposure Profiles in Adult Smokers
This study is designed to evaluate the abuse liability of mentholated very low nicotine cigarettes compared to nicotine gum and usual brand cigarettes.
Read the detailed description
This study will be a randomized, two-part, 3-way crossover designed to evaluate the abuse liability, pharmacokinetics (PK), and product use behavior associated with study products, including menthol VLN cigarettes, subjects' own-brand cigarettes, and nicotine polacrilex gum in healthy adult male and female exclusive smokers. Subjects will participate in a standard Screening visit and one 7-day Confined Assessment Phase, which will include a product trial session (Day -1), and two study parts (Part A and Part B). Following the Screening visit, eligible subjects will check-in to the study site on Day -1. Following the polacrilex gum training session, subjects will be required to abstain from nicotine- and tobacco-containing products for approximately 20 hours until the first product use session on Days 1 to 3; use of other nicotine-containing products will be prohibited throughout the study. No additional tobacco or nicotine products will be provided after the second product use on Days 4 to 6.
On Day 1, subjects will be randomized to one of three product sequence groups in Part A, which will consist of an ad libitum product use session for each of the following study products for 4 hours in a randomized crossover manner (Days 1 to 3; one product per day):
Product A: VLN menthol cigarette
Product B: Own-brand filtered standard king size menthol cigarette
Product C: 4 mg Nicotine polacrilex gum
A pharmacodynamic measure ("use product again" visual analog scale (VAS)) will be administered at the end of each ad libitum product use period. Product use behaviors (i.e., number of units consumed,duration of gum in mouth) will be collected throughout each ad libitum product use period. Upon completion of Part A, subjects will be randomized to one of three product sequence groups in Part B, which will consist of 3 study days (Days 4 to 6), with one product per day. Each study day will consist of: 1) Controlled Product Use Session (10 puffs from their own-brand cigarette or VLN menthol cigarette [maximum 3 ± 2 seconds per puff] at approximately 30 ± 5-second interpuff intervals, or chew the nicotine polacrilex gum using the "chew and park" method for 10 minutes); and 2) Uncontrolled Product Use Session (ad libitum use for 10 minutes). The Controlled Product Use Session and Uncontrolled Product Use Session will be separated by approximately 6 hours. During Part B, pharmacodynamic measures, pharmacokinetics (PK) , and product use behavior (Uncontrolled only) will be collected at various time points each day.
- Conditions
- Tobacco Use
- Being tested
- VLN menthol cigarettes (A), Usual Brand Menthol Cigarettes (B), Nicotine gum (C)
- Keywords
- Abuse liability
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLN menthol cigarettes (A)Other
0.4mg nicotine / g tobacco king size filter menthol cigarette
Usual Brand Menthol Cigarettes (B)Other
Usual brand king size menthol cigarettes
Nicotine gum (C)Drug
4 mg nicotine gum
| Study group | Role | What they receive |
|---|---|---|
| VLN Menthol Cigarettes (A) | Experimental | Subjects will smoke VLN menthol cigarettes Receives: Other: Usual Brand Menthol Cigarettes (B); Drug: Nicotine gum (C) |
| Usual Brand Menthol Cigarettes (B) | Experimental | Subjects will smoke their usual brand menthol cigarettes Receives: Other: VLN menthol cigarettes (A); Drug: Nicotine gum (C) |
| Nicotine Gum (C) | Experimental | Subjects will chew nicotine gum Receives: Other: VLN menthol cigarettes (A); Other: Usual Brand Menthol Cigarettes (B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emax_urge(controlled)
The maximum reduction in Visual Analog Scale (VAS) score for the question "Urges to smoke" (Tobacco/Nicotine Withdrawal Questionnaire) between pre-use and post-use (i.e., VASpre-use1 - VASpost-use1) during the first product use in Part B.
Measured: 3 days - administered at the end of each product use session (Use of each product on a different day)
Secondary outcomes (39)
Cmax(controlled); Maximum Nicotine Concentration
Maximum measured plasma nicotine concentration during the Controlled Use Session.
Measured: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
T1/2(controlled); Terminal Half Life
Apparent first-order terminal nicotine elimination half-life calculated as 0.693/Kel of the plasma concentration-time curve from time zero (defined as the start of controlled use) to 180 minutes
Measured: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
Kel(controlled); Elimination Rate Constant
Apparent first-order terminal nicotine elimination rate constant calculated from a semi-log plot of the plasma concentration-time curve of the Controlled Use Session.
Measured: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
Tmax(controlled); Maximum Time
Time of the maximum measured plasma nicotine concentration during the Controlled Use Session.
Measured: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
AUC(controlled); Area under the nicotine concentration-time curve
Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time zero (defined as the start of controlled use) to 180 minutes (or the last quantifiable concentration during that interval).
Measured: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
Cmax(uncontrolled); Maximum Nicotine Concentration
Maximum measured plasma nicotine concentration during the Uncontrolled Use Session.
Measured: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
T1/2(uncontrolled); Terminal Half Life
Apparent first-order terminal nicotine elimination half-life calculated as 0.693/Kel of the plasma concentration-time curve from time zero (defined as the start of uncontrolled use) to 540 minutes.
Measured: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
Kel(uncontrolled); Elimination Rate Constant
Apparent first-order terminal nicotine elimination rate constant calculated from a semi-log plot of the plasma concentration-time curve of the Controlled Use Session.
Measured: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
Tmax(uncontrolled); Maximum Time
Time of the maximum measured plasma nicotine concentration during the Uncontrolled Use Session.
Measured: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
AUC(uncontrolled); Area under the nicotine concentration-time curve
Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time 360 (defined as the start of uncontrolled use) to 540 minutes (or the last quantifiable concentration during that interval).
Measured: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
Emax_urge (Uncontrolled)
The largest VAS score recorded for the response to "Urges to Smoke" (Tobacco/nicotine withdrawal questionnaire) during the product use in Uncontrolled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minute
Emax_anx (Controlled)
The largest VAS score recorded for the response to "Urges to Smoke" (Tobacco/nicotine withdrawal questionnaire) during the product use in Uncontrolled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_anx (Uncontrolled)
The largest VAS score recorded for the response to "Anxious" (Tobacco/nicotine withdrawal questionnaire) during the product use in Uncontrolled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_diffct (Controlled)
The largest VAS score recorded for the response to "Difficulty Concentrating" (Tobacco/nicotine withdrawal questionnaire) during the product use in Controlled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_diffct (Uncontrolled)
The largest VAS score recorded for the response to "Difficulty Concentrating" (Tobacco/nicotine withdrawal questionnaire) during the product use in Controlled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_impat (Controlled)
The largest VAS score recorded for the response to "Impatient" (Tobacco/nicotine withdrawal questionnaire) during the product use in Controlled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_impat (Uncontrolled)
The largest VAS score recorded for the response to "Impatient" (Tobacco/nicotine withdrawal questionnaire) during the product use in Uncontrolled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_crav (Controlled)
The largest VAS score recorded for the response to "Craving a Cigarette" (Tobacco/nicotine withdrawal questionnaire) during the product use in Controlled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_crav (Uncontrolled)
The largest VAS score recorded for the response to "Craving a Cigarette" (Tobacco/nicotine withdrawal questionnaire) during the product use in Uncontrolled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_plas (Uncontrolled)
The largest VAS score recorded for the response to "Pleasant" (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_stf (Uncontrolled)
The largest VAS score recorded for the response to "Satisfying" (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_stf (Controlled)
The largest VAS score recorded for the response to "Satisfying" (Direct effects of product questionnaire) during the product use in Controlled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_calm (Uncontrolled)
The largest VAS score recorded for the response to "Calm" (Direct effects of product questionnaire) during the product use in Controlled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_calm (Controlled)
The largest VAS score recorded for the response to "Calm" (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_conc (Uncontrolled)
The largest VAS score recorded for the response to "Concentrate" (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_conc (controlled)
The largest VAS score recorded for the response to "Concentrate" (Direct effects of product questionnaire) during the product use in controlled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_awake (Uncontrolled)
The largest VAS score recorded for the response to "Awake" (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_awake (controlled)
he largest VAS score recorded for the response to "Awake" (Direct effects of product questionnaire) during the product use in controlled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_sick (Uncontrolled)
The largest VAS score recorded for the response to "Sick" (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_sick (Controlled)
The largest VAS score recorded for the response to "Sick" (Direct effects of product questionnaire) during the product use in Controlled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_hunger (Uncontrolled)
The largest VAS score recorded for the response to "Hunger" (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_hunger (Controlled)
The largest VAS score recorded for the response to "Hunger" (Direct effects of product questionnaire) during the product use in Controlled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_more (Uncontrolled)
The largest VAS score recorded for the response to "More" (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Emax_more (Controlled)
The largest VAS score recorded for the response to "More" (Direct effects of product questionnaire) during the product use in Controlled Section of Part B.
Measured: pre, 5, 15, 30, 60, and 90 minutes
Inhalations
Number of product inhalations (cigarettes only) during uncontrolled use sessions
Measured: 3 product use days (Use of each product on a different day)
Puff durations
Duration of inhalations (cigarettes only) during uncontrolled use sessions
Measured: 2 product use days (Use of each product on a different day)
Gum durations
Duration of gum in mouth during uncontrolled use sessions
Measured: 1 product use day
Use Product Again
The VAS score recorded for the response to "Use Product Again" (Use product again questionnaire) during the ad libitum product use in Part A.
Measured: 1 product use day
Emax_plst(controlled)
The largest VAS score recorded for the response to the question "Is the product "Pleasant" right now?" (Direct Effects of Product Questionnaire) during the first product use in Part B
Measured: 3 days - administered at the end of each product use session (Use of each product on a different day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 May 2018
- Primary completion4 Oct 2018
- Study completion4 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In part A each subject will have the opportunity to use either their own brand cigarette, nicotine gum or VLN menthol cigarettes ad libitum for 4 hours after which they will answer a questionnaire on using the product again. In Part B the subjects will have a controlled use session with each product followed by and uncontrolled session.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- 22nd Century Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vince & Associates Clinical Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Debra Kelsh, MD, Principal investigator, Vince and Associates Clinical Research, INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559725
- Sponsor's protocol ID
- CEG-P1-078
- Status last verified
- Mar 2020
- First submitted
- 23 May 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- 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 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Mentholated Cigarettes With Characterization of Nicotine Exposure Profiles in Adult Smokers
- ClinicalTrials.gov ID
- NCT03559725
- Acronym / sponsor ID
- CEG-P1-078
- Conditions
- Tobacco Use
- Keywords
- Abuse liability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- 22nd Century Group, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Vince & Associates Clinical Research, Inc.
- Study start
- 1 May 2018 (actual)
- Primary completion
- 4 Oct 2018 (actual)
- Study completion
- 4 Oct 2018 (actual)
- First posted
- 18 Jun 2018 (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 study is designed to evaluate the abuse liability of mentholated very low nicotine cigarettes compared to nicotine gum and usual brand cigarettes.
Detailed description
This study will be a randomized, two-part, 3-way crossover designed to evaluate the abuse liability, pharmacokinetics (PK), and product use behavior associated with study products, including menthol VLN cigarettes, subjects' own-brand cigarettes, and nicotine polacrilex gum in healthy adult male and female exclusive smokers. Subjects will participate in a standard Screening visit and one 7-day Confined Assessment Phase, which will include a product trial session (Day -1), and two study parts (Part A and Part B). Following the Screening visit, eligible subjects will check-in to the study site on Day -1. Following the polacrilex gum training session, subjects will be required to abstain from nicotine- and tobacco-containing products for approximately 20 hours until the first product use session on Days 1 to 3; use of other nicotine-containing products will be prohibited throughout the study. No additional tobacco or nicotine products will be provided after the second product use on Days 4 to 6.
On Day 1, subjects will be randomized to one of three product sequence groups in Part A, which will consist of an ad libitum product use session for each of the following study products for 4 hours in a randomized crossover manner (Days 1 to 3; one product per day):
Product A: VLN menthol cigarette
Product B: Own-brand filtered standard king size menthol cigarette
Product C: 4 mg Nicotine polacrilex gum
A pharmacodynamic measure ("use product again" visual analog scale (VAS)) will be administered at the end of each ad libitum product use period. Product use behaviors (i.e., number of units consumed,duration of gum in mouth) will be collected throughout each ad libitum product use period. Upon completion of Part A, subjects will be randomized to one of three product sequence groups in Part B, which will consist of 3 study days (Days 4 to 6), with one product per day. Each study day will consist of: 1) Controlled Product Use Session (10 puffs from their own-brand cigarette or VLN menthol cigarette [maximum 3 ± 2 seconds per puff] at approximately 30 ± 5-second interpuff intervals, or chew the nicotine polacrilex gum using the "chew and park" method for 10 minutes); and 2) Uncontrolled Product Use Session (ad libitum use for 10 minutes). The Controlled Product Use Session and Uncontrolled Product Use Session will be separated by approximately 6 hours. During Part B, pharmacodynamic measures, pharmacokinetics (PK) , and product use behavior (Uncontrolled only) will be collected at various time points each day.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- In part A each subject will have the opportunity to use either their own brand cigarette, nicotine gum or VLN menthol cigarettes ad libitum for 4 hours after which they will answer a questionnaire on using the product again. In Part B the subjects will have a controlled use session with each product followed by and uncontrolled session.
| Arm | Type | Receives |
|---|---|---|
| VLN Menthol Cigarettes (A) | Experimental | Other: Usual Brand Menthol Cigarettes (B), Drug: Nicotine gum (C)Subjects will smoke VLN menthol cigarettes |
| Usual Brand Menthol Cigarettes (B) | Experimental | Other: VLN menthol cigarettes (A), Drug: Nicotine gum (C)Subjects will smoke their usual brand menthol cigarettes |
| Nicotine Gum (C) | Experimental | Other: VLN menthol cigarettes (A), Other: Usual Brand Menthol Cigarettes (B)Subjects will chew nicotine gum |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects will be required to meet each one of the following inclusion criteria in order to be eligible for participation in the study:
- Must provide written informed consent prior to the initiation of any protocol-specific procedures.
- Male and female adults, between 22 to 65 years of age, inclusive.
- Body mass index (BMI) within 18.0 to 35.0 kg/m2, inclusive (minimum weight of at least 50.0 kg at Screening).
- Healthy, as determined by no clinically significant medical history, physical examination, 12-lead ECG, vital signs or laboratory (including hematology, clinical chemistry, urinalysis, and serology) findings at Screening, as judged by an investigator.
Key exclusion criteria (19 listed)
- Subjects will not be eligible to participate in this study if any one of the following exclusion criteria is met:
- Inability to tolerate 4 mg nicotine polacrilex gum during product use trial on Day -1 (check-in) or dentition prevents subjects from chewing gum.
- History or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease at Screening, which in the opinion of an investigator would jeopardize the safety of the subject or the validity of the study results.
- History or presence of any type of malignant tumors.
- Clinically significant abnormal findings on the vital signs, physical examination (including oral exam), medical history, or clinical laboratory results, in the opinion of an investigator.
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 |
|---|---|---|
| VLN menthol cigarettes (A)0.4mg nicotine / g tobacco king size filter menthol cigarette | Other | Nicotine Gum (C), Usual Brand Menthol Cigarettes (B) |
| Usual Brand Menthol Cigarettes (B)Usual brand king size menthol cigarettes | Other | Nicotine Gum (C), VLN Menthol Cigarettes (A) |
| Nicotine gum (C)4 mg nicotine gum | Drug | Usual Brand Menthol Cigarettes (B), VLN Menthol Cigarettes (A) |
Primary outcome
Emax_urge(controlled)
Time frame: 3 days - administered at the end of each product use session (Use of each product on a different day)
The maximum reduction in Visual Analog Scale (VAS) score for the question "Urges to smoke" (Tobacco/Nicotine Withdrawal Questionnaire) between pre-use and post-use (i.e., VASpre-use1 - VASpost-use1) during the first product use in Part B.
39 secondary outcomes
Cmax(controlled); Maximum Nicotine Concentration
Time frame: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
T1/2(controlled); Terminal Half Life
Time frame: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
Kel(controlled); Elimination Rate Constant
Time frame: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
Tmax(controlled); Maximum Time
Time frame: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
AUC(controlled); Area under the nicotine concentration-time curve
Time frame: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
Cmax(uncontrolled); Maximum Nicotine Concentration
Time frame: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
T1/2(uncontrolled); Terminal Half Life
Time frame: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
Kel(uncontrolled); Elimination Rate Constant
Time frame: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
Tmax(uncontrolled); Maximum Time
Time frame: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
AUC(uncontrolled); Area under the nicotine concentration-time curve
Time frame: Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes
Emax_urge (Uncontrolled)
Time frame: pre, 5, 15, 30, 60, and 90 minute
Emax_anx (Controlled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_anx (Uncontrolled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_diffct (Controlled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_diffct (Uncontrolled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_impat (Controlled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_impat (Uncontrolled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_crav (Controlled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_crav (Uncontrolled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_plas (Uncontrolled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_stf (Uncontrolled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_stf (Controlled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_calm (Uncontrolled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_calm (Controlled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_conc (Uncontrolled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_conc (controlled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_awake (Uncontrolled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_awake (controlled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_sick (Uncontrolled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_sick (Controlled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_hunger (Uncontrolled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_hunger (Controlled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_more (Uncontrolled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Emax_more (Controlled)
Time frame: pre, 5, 15, 30, 60, and 90 minutes
Inhalations
Time frame: 3 product use days (Use of each product on a different day)
Puff durations
Time frame: 2 product use days (Use of each product on a different day)
Gum durations
Time frame: 1 product use day
Use Product Again
Time frame: 1 product use day
Emax_plst(controlled)
Time frame: 3 days - administered at the end of each product use session (Use of each product on a different day)
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 25 Mar 2020.
- 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.
Debra Kelsh, MD principal investigator
Vince and Associates Clinical Research, INC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VLN menthol cigarettes (A), Usual Brand Menthol Cigarettes (B) and Nicotine gum (C) in people with Tobacco Use, run by 22nd Century Group, Inc. 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 19 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 25 Mar 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Emax_urge(controlled) (time frame: 3 days - administered at the end of each product use session (Use of each product on a different day)). 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 25 Mar 2020.