Nicotine Pharmacokinetics and Subjective Effects of Oral Nicotine Products Relative to Smokeless Tobacco in Adult Users

Completed · Not applicable

Conditions studied: Tobacco Use

In brief

The purpose of this study was to obtain information on nicotine exposure following the use of five oral tobacco-derived nicotine (OTDN) products relative to subjects' own brand moist smokeless tobacco (OBMST) product in adult moist smokeless tobacco (MST) users, as well as to characterize subjective effects under controlled use conditions. Male and female adult MST users between the ages of 22 to 65 years were recruited. The total duration of participation for each subject was approximately 34 days including screening and a 6-day in-clinic study confinement period.

Key facts

Study ID

NCT06691386

Run by

Altria Client Services LLC

People needed

64

Starts

2023-02-06

Expected to finish

2024-02-08

Last updated by the study team

2025-01-17

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntary consent to participate in this study documented on the signed informed consent form (ICF).
• Adult males and females 22 to 65 years of age, inclusive, at Screening. Full COVID-19 vaccination (FDA authorized vaccines) record that was completed at least 14 days prior to Screening for subjects >45 years of age. Full vaccination as defined by the Centers for Disease Control and Prevention.
• Self-affirmed adult consumers of MST with usual brand of COPENHAGEN Fine Cut, or COPENHAGEN Long Cut, SKOAL Long Cut, or GRIZZLY Long Cut MST products in Mint, Natural, and Wintergreen flavor variants (and a single Straight variant; consumption of at least ½ can per day in the 30 days prior to Screening) for at least 12 months prior to Check-in; subjects cannot reject any of the flavor variants. Brief periods (i.e., up to 7 consecutive days) of non-MST usage within 90 days before Check-in (e.g., due to illness, participation in a clinical study where tobacco use was prohibited) will not be exclusionary at the discretion of the Investigator.
• Positive urine cotinine (≥ 500 ng/mL) at Screening.
• Negative pregnancy test at Screening, prior to the start of Product Trial, and Check-in (Day -1) for all female subjects.
• Female subjects who are heterosexually active and of childbearing potential (e.g., not surgically sterile at least 6 months prior to Check-in nor postmenopausal with amenorrhea for at least 1 year prior to Check-in and FSH levels consistent with postmenopausal status) 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, injection) consistently for at least 3 months prior to Check-in,
• double barrier (e.g., condom with spermicide or diaphragm with spermicide) consistently for at least 2 weeks prior to Check-in,
• intrauterine device for at least 3 months prior to Check-in,
• exclusive partner who has been vasectomized for at least 6 months (inclusive) prior to Check-in.
• Female subjects of childbearing potential who are not currently engaging in heterosexual intercourse must agree to use one of the above methods of birth control through completion of study, in the event that they have heterosexual intercourse during the course of the study.
• Female subjects who are of nonchildbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Check-in:
• hysteroscopic sterilization with documentation of success with hysterosalpingogram;
• bilateral tubal ligation or bilateral salpingectomy;
• hysterectomy;
• bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year prior to Check-in and have FSH levels consistent with postmenopausal status.
• Willing to comply with the requirements of the study.
• Willing and able to use all oral TDN study products for at least 45 minutes.

You may not qualify if…

• Subjects will be excluded from the study if there is evidence of any of the following criteria at Screening or Check-in, or at any time during the study as appropriate.
• An ad libitum pinch mass that is less than 2 g as captured at the Follow-up Screening visit.
• Use of any oral TDN or nicotine-containing products with the exception of MST and combustible cigarettes (e.g., nicotine lozenge, nicotine gum, nicotine inhaler, nicotine mouth spray, nicotine pouch) within the past 30 days prior to the screening visit.
• Any postponement of a quit attempt in order to participate in the study.
• Attempts to quit MST product use in the 3 months prior to Day -1 (Check- in).
• Planning to quit MST product use in the next 3 months (from Screening visit).
• Negative response (i.e., unwilling to use or unable to tolerate [e.g., experiences AEs during the Product Trial that will prevent them from continuing to use the product as judged by the Investigator]) to any of the oral TDN study products during the Product Trial.
• Dentition that prevents subjects from using products.
• History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary, 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 vital signs, physical examination (including oral cavity and oropharynx), medical history, or clinical laboratory results, in the opinion of the Investigator.
• Positive test for HIV, HBsAg, COVID-19 or HCV at Screening or Check-in, as applicable.
• History or presence of any type of malignant tumors.
• Current evidence or any history of congestive heart failure.
• Diabetes mellitus that is not controlled by diet/exercise alone, in the opinion of the Investigator. Fasting serum glucose of 126 mg/dL [7 mmol/L] is exclusionary. One re-check may be performed for values greater than or equal to 126 mg/dL but less than 200 mg/dL.
• An acute illness (e.g., upper respiratory infection, viral infection) requiring treatment with prescribed medicines within 2 weeks prior to Check-in or at the discretion of the Investigator.
• Presence of gum bleeding and/or abscess, open mouth sores or oral ulcers at Screening or Check-in.
• Allergic to or cannot tolerate mint, cool mint, spearmint, or peppermint flavoring agents.
• Any planned surgery from the time of Screening through the End-of-Study.
• History of drug or alcohol abuse within 24 months prior to Check-in.
• Fever (i.e., body temperature > 100.5 ͦ F) at Screening or Check-in. One re-check may be performed at the Investigator's discretion.
• Systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg at Screening or Check-in, measured after being seated for at least 10 minutes. Two re-checks may be performed at the Investigator's discretion.
• BMI greater than 40.0 kg/m2 or less than 18.0 kg/m2 at Screening.
• Estimated glomerular filtration rate (eGFR) < 80 mL/minute (using the Modification of Diet in Renal Disease formula) at Screening.
• Serum alanine aminotransferase (ALT) ≥ 1.5 times the upper limit of normal and/or aspartate aminotransferase (AST) ≥ 2.0 times the upper limit of normal at Screening.
• Positive urine/breath screen for alcohol at Screening or Check-in.

Where it is running

• Pillar Clinical Research LLC — Bentonville, Arkansas, United States
• QPS Bio-Kinetic — Springfield, Missouri, United States

Full record on ClinicalTrials.gov

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