Tobacco UseNCT03571724
A Study to Assess Changes in Cigarette Consumption During a Switch to Very Low Nicotine Cigarettes
A study testing Non-Menthol Very Low Nicotine Cigarettes, Menthol Very Low Nicotine Cigarettes and Subject's UB non-mentholated filtered cigarettes in people with Tobacco Use, run by 22nd Century Group, Inc. at 2 sites in United States.
Trial summary
This study evaluates the impact of switching from usual brand cigarettes to very low nicotine cigarettes on cigarette consumption, smoking behavior, and biomarkers of exposure. Read more about this study
- Who is it for?
- Ages 26 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Non-Menthol Very Low Nicotine Cigarettes, Menthol Very Low Nicotine Cigarettes and Subject's UB non-mentholated filtered cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jun 2018to 8 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 26 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Potential subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study.
- Is a healthy adult male or female adult smoker, 26 to 65 years of age, inclusive, at Screening.
- Has been a smoker for at least 5 years prior to Screening. Brief periods of non smoking (e.g., up to 7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) during that time will be permitted at the discretion of the Investigator.
- Reports smoking an average of 10 or more manufactured combustible cigarettes per day at Screening.
- Usual brand (UB) of cigarette is a filtered king size cigarette (with an approximate length of 84 mm (± 3 mm)).
- Has a positive urine cotinine (≥ 500 ng/ml) at Screening.
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- Has an exhaled Carbon Monoxide > 10 ppm at Screening.
- If female, has a negative serum pregnancy test at Screening.
- A female subject of childbearing potential must have been using one of the following forms of contraception and agree to continue using it through completion of the study:
- hormonal (e.g., oral, vaginal ring, transdermal patch, implant, or injection) consistently for at least 3 months prior to Screening;
- double barrier method (e.g., condom with spermicide, diaphragm with spermicide) consistently for at least 14 days prior to Screening;
- intrauterine device for at least 3 months prior to Screening;
- Essure® or similar nonsurgical sterilization procedure at least 6 months prior to Screening
- a partner who has been vasectomized for at least 6 months prior to Screening;
- abstinence beginning at least 14 days prior to Screening and through the End of Study.
- A female subject of non childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Screening:
- hysteroscopic sterilization;
- bilateral tubal ligation or bilateral salpingectomy;
- hysterectomy;
- bilateral oophorectomy; Or be postmenopausal with amenorrhea for at least 1 year prior to Day 1 and follicle stimulating hormone (FSH) levels consistent with postmenopausal status.
- Willing to comply with the requirements of the study, including a willingness to use the test products.
- Voluntary consent to participate in this study documented on the signed informed consent form (ICF).
- Subject is not planning to leave the area during the course of the study.
Who cannot join
- Subjects may be excluded from the study if there is evidence of any of the following criteria at Screening, start of Week -1 (first clinic visit), or during the study as noted, in the opinion of the Investigator.
- History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary (especially bronchospastic diseases and asthma), immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Clinically significant abnormal findings on the physical examination, medical history, ECG, or clinical laboratory results, in the opinion of the Investigator.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- An acute illness (e.g., upper respiratory infection, viral infection) requiring treatment with prescription medication(s) within 14 days prior to Screening or first clinic visit.
- Fever (>100.5 degrees F) at Screening or first clinic visit.
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- Body mass index (BMI) greater than 40.0 kg/m2 or less than 18.0 kg/m2 at Screening.
- History of drug or alcohol abuse or has used medical/recreational marijuana within 12 months of Screening.
- Diabetes mellitus that is not controlled by diet/exercise alone, in the opinion of the Investigator.
- Seated heart rate is lower than 40 bpm or higher than 99 bpm at Screening, unless deemed not clinically significant by the PI.
- Seated systolic blood pressure <90 mmHg or >150 mmHg, diastolic blood pressure <40 mmHg or >95 mmHg at Screening, unless deemed not clinically significant by the PI.
- Positive urine screen for drugs of abuse or alcohol at Screening or at the first clinic visit.
- Female subjects who are pregnant, lactating, or intend to become pregnant from Screening through the End of Study.
- Use of medications known to interact with cytochrome p450 2A6 (including, but not limited to, amiodarone, desipramine, isoniazid, ketoconazole, miconazole, phenobarbital, rifampin, tranylcypromine, methoxsalen) within 3 months prior to Screening and throughout the study.
- Use of inhalers to treat any medical condition within 3 months prior to Screening and throughout the study.
- Use of nicotine-containing products other than factory manufactured cigarettes [e.g., roll-your-own cigarettes, e-vapor products, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum] within 28 days prior to Screening.
- Use of any prescription smoking cessation treatments, including, but not limited to, varenicline (Chantix®) or buproprion (Zyban®) within 3 months prior to Screening.
- Self-reported puffer/non-inhaler (i.e., a smoker who draws smoke from the cigarette into the mouth and throat but does not inhale).
- Planning to quit smoking during the study period or postponing a quit attempt in order to participate in the study.
- Plasma donation within 7 days prior to Screening or at any time during the study.
- Donation of blood or blood products (with the exception of plasma as noted above), had significant blood loss, or received whole blood or a blood product transfusion within 56 days prior to Screening.
- Participation in a previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to Screening.
- Subject or a first-degree relative (i.e., parent, sibling, child) is a current or former employee of the tobacco industry or a named party or class representative in litigation with the tobacco industry.
- Subject or a first-degree relative (i.e., parent, sibling, child) is a current employee of the clinic sites.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
High Point Clinical Trials
High Point, North Carolina, 27265
Celerion
Lincoln, Nebraska, 68502
About this study
Official title: A Longitudinal Ambulatory Study to Assess Changes in Cigarette Consumption and Biomarkers of Exposure During a 6-week Switch to Very Low Nicotine Cigarettes
This study evaluates the impact of switching from usual brand cigarettes to very low nicotine cigarettes on cigarette consumption, smoking behavior, and biomarkers of exposure.
Read the detailed description
Very low nicotine (VLN) cigarettes contain a 'non-additive' level of nicotine. This study will switch smokers from their usual brand to VLN cigarettes. Periodically during the study the investigators will collect blood and measure nicotine exposure and also other biomarkers to see what effect switching has. The participants will also use a diary to record number of cigarettes smoked. Cigarette butts will also be collected.
- Conditions
- Tobacco Use
- Being tested
- Non-Menthol Very Low Nicotine Cigarettes, Menthol Very Low Nicotine Cigarettes, Subject's UB non-mentholated filtered cigarettes, Subject's UB mentholated filtered cigarettes
- Keywords
- Very Low Nicotine, Cigarette, VLN
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Menthol Very Low Nicotine CigarettesOther
King size non-menthol cigarettes containing 0.4mg nicotine /g tobacco
Menthol Very Low Nicotine CigarettesOther
King size menthol cigarettes containing 0.4mg nicotine /g tobacco
Subject's UB non-mentholated filtered cigarettesOther
King size non-menthol cigarettes
Subject's UB mentholated filtered cigarettesOther
King size menthol cigarettes
| Study group | Role | What they receive |
|---|---|---|
| Usual Brand (UB) non-mentholated filtered cigarettes | Experimental | Usual Brand (UB) mentholated filtered cigarettes Usual Brand (UB) non-mentholated filtered cigarettes or to very low nicotine non-mentholated cigarettes Receives: Other: Non-Menthol Very Low Nicotine Cigarettes; Other: Subject's UB non-mentholated filtered cigarettes |
| Usual Brand (UB) mentholated filtered cigarettes | Experimental | Subjects will be randomized to continue to smoke Usual Brand (UB) mentholated filtered cigarettes or to very low nicotine mentholated cigarettes Receives: Other: Menthol Very Low Nicotine Cigarettes; Other: Subject's UB mentholated filtered cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarettes Per Day
Primary objective is to measure a change in cigarette consumption behavior before, during and after switching from usual brand to to VLN cigarettes. Subjects will record their cigarette consumption daily in an electronic diary. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).All 142 randomized subjects were included in the ITT population based on product use. Out of these, 71 subjects were included in the PP Population and 71 were excluded. All excluded subjects had a ratio of [plasma cotinine/CPD VLN]/[plasma cotinine/CPD baseline] > 0.2. It was pre-specified to exclude participants with a ratio >0.2 as they were considered non-compliant.
Measured: Assessed daily from Week -1 to Week 6; Week -1, Week 2, and Week 6 reported
Secondary outcomes (20)
Biomarkers of Exposure - Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1 Butanol (NNAL)
Total 24 hour urine will be collected to evaluate changes in NNAL (4-methylnitrosamino)-1-3-pyridyl)-1-butanone biomarker) before, during, and after switching to VLN cigarettes. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).
Measured: -1 week, and at 2 and 6 weeks.
Biomarkers of Exposure - Total N-Nitrosonornicotine (NNN)
Total 24 hour urine will be collected to evaluate changes in NNN before, during, and after switching to VLN cigarettes. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).
Measured: -1 week, and at 2 and 6 weeks.
Biomarkers of Exposure - S-phenylmercapturic Acid (S-PMA)
Total 24 hour urine will be collected to evaluate changes in S-PMA (benzene biomarker) before, during, and after switching to VLN cigarettes. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).
Measured: -1 week, and at 2 and 6 weeks.
Biomarkers of Exposure - 3-hydroxypropylmercapturic Acid (3-HPMA)
Total 24 hour urine will be collected to evaluate changes in 3-HPMA (acrolein biomarker) before, during, and after switching to VLN cigarettes. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).
Measured: -1 week, and at 2 and 6 weeks.
Biomarkers of Exposure - 1-hydroxy Pyrene(1-OHP)
Total 24 hour urine will be collected to evaluate changes in 1-OHP before, during, and after switching to VLN cigarettes. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).
Measured: -1 week, and at 2 and 6 weeks.
Biomarkers of Exposure - Total Nicotine Equivalents
Total 24 hour urine will be collected to evaluate changes in total nicotine equivalents before, during, and after switching to VLN cigarettes. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).
Measured: -1 week, and at 2 and 6 weeks.
Biomarkers of Exposure - Carboxyhemoglobin (COHb)
Blood will be drawn to evaluate COHb before, during, and after switching to VLN cigarettes. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).
Measured: Week -1, and at 2 and 6 weeks.
Biomarkers of Exposure -Cotinine
Blood will be drawn to evaluate cotinine levels before, during, and after switching to VLN cigarettes. The baseline data were collected for participants at Week -1, and Week -1 data are reported per pre-switch Arms/Group assignment.
Measured: Week -1, and at 2 and 6 weeks.
Nicotine Pharmacokinetics - Maximum Nicotine Concentration (C-Max)
Blood samples will be drawn at -5, 2, 5, 7, 10, 12, 15, 20, 30, 45, 60, 90, 120, 150 and 180 minutes relative to the start of cigarette smoking a single cigarette for determination of C-max at weeks -1, 2 and 6. The baseline data were collected for participants at Week -1, and Week -1 data are reported per pre-switch Arms/Group assignment.
Measured: Week -1, and at 2 and 6 weeks.
Nicotine Pharmacokinetics - Peak Nicotine Time (T-Max)
Blood samples will be drawn at -5, 2, 5, 7, 10, 12, 15, 20, 30, 45, 60, 90, 120, 150 and 180 minutes relative to the start of cigarette smoking a single cigarette for determination of T-Max at weeks -1, 2 and 6. The baseline data were collected for participants at Week -1, and Week -1 data are reported per pre-switch Arms/Group assignment.
Measured: Week -1, and at 2 and 6 weeks.
Nicotine Pharmacokinetics - Area Under Nicotine Concentration Curve (AUC)
Blood samples will be drawn at -5, 2, 5, 7, 10, 12, 15, 20, 30, 45, 60, 90, 120, 150 and 180 minutes relative to the start of cigarette smoking a single cigarette for determination of AUC at weeks -1, 2 and 6. The baseline data were collected for participants at Week -1, and Week -1 data are reported per pre-switch Arms/Group assignment.
Measured: Week -1, and at 2 and 6 weeks.
Smoking Topography - Puff Duration
Puff duration will be measured before, during, and after switching to VLN cigarettes. Topography will be measured during an ad libitum smoking session. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).
Measured: -1 week, and at 2 and 6 weeks.
Smoking Topography - Puff Volume
Puff volume will be measured before, during, and after switching to VLN cigarettes. Topography will be measured during an ad libitum smoking session. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).
Measured: -1 week, and at 2 and 6 weeks.
Smoking Topography - Peak Puff Flow Rate
Peak Puff Flow Rate will be measured before, during, and after switching to VLN cigarettes. Topography will be measured during an ad libitum smoking session. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).
Measured: -1 week, and at 2 and 6 weeks.
Smoking Topography - Average Flow Rate
Average Puff Flow Rate will be measured before, during, and after switching to VLN cigarettes. Topography will be measured during an ad libitum smoking session. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).
Measured: -1 week, and at 2 and 6 weeks.
Smoking Topography - Inter-puff Interval
Inter-puff interval will be measured before, during, and after switching to VLN cigarettes. Topography will be measured during an ad libitum smoking session. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).
Measured: -1 week, and at 2 and 6 weeks.
Subjective Effects -Fagerstrom Test for Cigarette Dependance (FTCD)
Subjects will answer a Fagerstrom Test for Cigarette Dependance (FTCD) questionnaire which contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence.The Fagerstrom Test for Nicotine Dependence, is scored from 0 to 1 for yes/no items and 0 to 3 for multiple-choice items.The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the greater the patient's physical dependence on nicotine. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).
Measured: -1 week, and at 2, 4, and 6 weeks.
Subjective Effects -Brief Questionnaire of Smoking Urges (QSU-Brief)
Subjects will answer a Brief Questionnaire of Smoking Urges (QSU-Brief). QSU is on a scale of 1-7, with 1 being strongly disagree and 7 being strongly agree. The average score of the following is taken to determine the Factor Score 1 and Factor Score 2; Factor 1: Average of Questions 1, 3, 6, 7, and 10; Factor 2: Average of Questions 2, 4, 5, 8, and 9. The score for each factor is calculated by summing the item scores; the total score is calculated by summing all questions together. The higher the score, the greater the urge to smoke. The total score range for this questionnaire is 10-70. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).
Measured: Week -1, and at 2, 4, and 6 weeks.
Subjective Effects - Minnesota Nicotine Withdrawal Scale - Revised (MNWS-R)
Subjects will answer a MNWS-R questionnaire. The MNWS is considered as the briefest scale among the self-report measures of nicotine withdrawal symptoms currently available. The original MNWS was developed by Hughes and Hatsukami in 1986. It consisted of nine nicotine withdrawal symptoms including craving. The scale was modified to reflect changes made in the fourth edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for nicotine withdrawal. The total score of the scale range from 0 to 36 depending on participant's rate for the symptoms as not present (0), slight (1), mild (2), moderate (3), and severe (4). A high total score implies high nicotine addiction. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).
Measured: -1 week, and at 2, 4, and 6 weeks.
Subjective Effects - Perceived Health Risks
Subjects will answer a Perceived health risks questionnaire. The subjects indicated their perception of the risk of becoming addicted to the cigarette they were currently using on a scale from 1 to 10. Scale =1 was a very low risk of becoming addicted and Scale =10 was a very high risk of becoming addicted. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).
Measured: -1 week, and at 2, 4, and 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start28 Jun 2018
- Primary completion25 Jan 2019
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal ambulatory switching study
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- 22nd Century Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Philip L Matthew, MD, Principal investigator, CelerionMelanie Fein, Principal investigator, High Point Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571724
- Sponsor's protocol ID
- CA24914
- Status last verified
- Sep 2020
- First submitted
- 2 Jun 2018
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Ambulatory Study to Assess Changes in Cigarette Consumption and Biomarkers of Exposure During a 6-week Switch to Very Low Nicotine Cigarettes
- ClinicalTrials.gov ID
- NCT03571724
- Acronym / sponsor ID
- CA24914
- Conditions
- Tobacco Use
- Keywords
- Very Low Nicotine, Cigarette, VLN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- 22nd Century Group, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Posted 16 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the impact of switching from usual brand cigarettes to very low nicotine cigarettes on cigarette consumption, smoking behavior, and biomarkers of exposure.
Detailed description
Very low nicotine (VLN) cigarettes contain a 'non-additive' level of nicotine. This study will switch smokers from their usual brand to VLN cigarettes. Periodically during the study the investigators will collect blood and measure nicotine exposure and also other biomarkers to see what effect switching has. The participants will also use a diary to record number of cigarettes smoked. Cigarette butts will also be collected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Longitudinal ambulatory switching study
| Arm | Type | Receives |
|---|---|---|
| Usual Brand (UB) non-mentholated filtered cigarettes | Experimental | Other: Non-Menthol Very Low Nicotine Cigarettes, Other: Subject's UB non-mentholated filtered cigarettesUsual Brand (UB) mentholated filtered cigarettes Usual Brand (UB) non-mentholated filtered cigarettes or to very low nicotine non-mentholated cigarettes |
| Usual Brand (UB) mentholated filtered cigarettes | Experimental | Other: Menthol Very Low Nicotine Cigarettes, Other: Subject's UB mentholated filtered cigarettesSubjects will be randomized to continue to smoke Usual Brand (UB) mentholated filtered cigarettes or to very low nicotine mentholated cigarettes |
Who may qualify
- Ages
- 26 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Potential subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study.
- Is a healthy adult male or female adult smoker, 26 to 65 years of age, inclusive, at Screening.
- Has been a smoker for at least 5 years prior to Screening. Brief periods of non smoking (e.g., up to 7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) during that time will be permitted at the discretion of the Investigator.
- Reports smoking an average of 10 or more manufactured combustible cigarettes per day at Screening.
- Usual brand (UB) of cigarette is a filtered king size cigarette (with an approximate length of 84 mm (± 3 mm)).
Key exclusion criteria (24 listed)
- Subjects may be excluded from the study if there is evidence of any of the following criteria at Screening, start of Week -1 (first clinic visit), or during the study as noted, in the opinion of the Investigator.
- History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary (especially bronchospastic diseases and asthma), immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Clinically significant abnormal findings on the physical examination, medical history, ECG, or clinical laboratory results, in the opinion of the Investigator.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- An acute illness (e.g., upper respiratory infection, viral infection) requiring treatment with prescription medication(s) within 14 days prior to Screening or first clinic visit.
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 |
|---|---|---|
| Non-Menthol Very Low Nicotine CigarettesKing size non-menthol cigarettes containing 0.4mg nicotine /g tobacco | Other | Usual Brand (UB) non-mentholated filtered cigarettes |
| Menthol Very Low Nicotine CigarettesKing size menthol cigarettes containing 0.4mg nicotine /g tobacco | Other | Usual Brand (UB) mentholated filtered cigarettes |
| Subject's UB non-mentholated filtered cigarettesKing size non-menthol cigarettes | Other | Usual Brand (UB) non-mentholated filtered cigarettes |
| Subject's UB mentholated filtered cigarettesKing size menthol cigarettes | Other | Usual Brand (UB) mentholated filtered cigarettes |
Primary outcome
Cigarettes Per Day
Time frame: Assessed daily from Week -1 to Week 6; Week -1, Week 2, and Week 6 reported
Primary objective is to measure a change in cigarette consumption behavior before, during and after switching from usual brand to to VLN cigarettes. Subjects will record their cigarette consumption daily in an electronic diary. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).All 142 randomized subjects were included in the ITT population based on product use. Out of these, 71 subjects were included in the PP Population and 71 were excluded. All excluded subjects had a ratio of [plasma cotinine/CPD VLN]/[plasma cotinine/CPD baseline] > 0.2. It was pre-specified to exclude participants with a ratio >0.2 as they were considered non-compliant.
20 secondary outcomes
Biomarkers of Exposure - Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1 Butanol (NNAL)
Time frame: -1 week, and at 2 and 6 weeks.
Biomarkers of Exposure - Total N-Nitrosonornicotine (NNN)
Time frame: -1 week, and at 2 and 6 weeks.
Biomarkers of Exposure - S-phenylmercapturic Acid (S-PMA)
Time frame: -1 week, and at 2 and 6 weeks.
Biomarkers of Exposure - 3-hydroxypropylmercapturic Acid (3-HPMA)
Time frame: -1 week, and at 2 and 6 weeks.
Biomarkers of Exposure - 1-hydroxy Pyrene(1-OHP)
Time frame: -1 week, and at 2 and 6 weeks.
Biomarkers of Exposure - Total Nicotine Equivalents
Time frame: -1 week, and at 2 and 6 weeks.
Biomarkers of Exposure - Carboxyhemoglobin (COHb)
Time frame: Week -1, and at 2 and 6 weeks.
Biomarkers of Exposure -Cotinine
Time frame: Week -1, and at 2 and 6 weeks.
Nicotine Pharmacokinetics - Maximum Nicotine Concentration (C-Max)
Time frame: Week -1, and at 2 and 6 weeks.
Nicotine Pharmacokinetics - Peak Nicotine Time (T-Max)
Time frame: Week -1, and at 2 and 6 weeks.
Nicotine Pharmacokinetics - Area Under Nicotine Concentration Curve (AUC)
Time frame: Week -1, and at 2 and 6 weeks.
Smoking Topography - Puff Duration
Time frame: -1 week, and at 2 and 6 weeks.
Smoking Topography - Puff Volume
Time frame: -1 week, and at 2 and 6 weeks.
Smoking Topography - Peak Puff Flow Rate
Time frame: -1 week, and at 2 and 6 weeks.
Smoking Topography - Average Flow Rate
Time frame: -1 week, and at 2 and 6 weeks.
Smoking Topography - Inter-puff Interval
Time frame: -1 week, and at 2 and 6 weeks.
Subjective Effects -Fagerstrom Test for Cigarette Dependance (FTCD)
Time frame: -1 week, and at 2, 4, and 6 weeks.
Subjective Effects -Brief Questionnaire of Smoking Urges (QSU-Brief)
Time frame: Week -1, and at 2, 4, and 6 weeks.
Subjective Effects - Minnesota Nicotine Withdrawal Scale - Revised (MNWS-R)
Time frame: -1 week, and at 2, 4, and 6 weeks.
Subjective Effects - Perceived Health Risks
Time frame: -1 week, and at 2, 4, and 6 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Cancer, Tobacco Use
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.
Philip L Matthew, MD principal investigator
Celerion
Melanie Fein principal investigator
High Point Clinical Trials
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Menthol Very Low Nicotine Cigarettes, Menthol Very Low Nicotine Cigarettes and Subject's UB non-mentholated filtered cigarettes in people with Tobacco Use, run by 22nd Century Group, Inc. 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 23 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. 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?
Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cigarettes Per Day (time frame: Assessed daily from Week -1 to Week 6; Week -1, Week 2, and Week 6 reported). 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 16 Sep 2020.