A Study to Evaluate Changes in Smokers Using Oral Tobacco-derived Nicotine Products.

Completed · Not applicable

Conditions studied: Tobacco Use

In brief

The purpose of this study is to evaluate changes in exposure to selected harmful and potentially harmful constituents (HPHC) by measuring biomarkers in adult smokers who partially or completely switch from smoking cigarettes to oral tobacco-derived nicotine (OTDN) products compared to those who continue exclusive smoking cigarettes or stop using all tobacco products.

Key facts

Study ID

NCT03692078

Run by

Altria Client Services LLC

People needed

231

Starts

2018-05-30

Expected to finish

2018-10-01

Last updated by the study team

2024-11-25

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Voluntary consent to participate in this study documented on the signed informed consent form (ICF).
• Healthy adult males and females 21 to 65 years of age, inclusive, at Screening
• Smoking history of an average of at least 10 but no more than 30 factory manufactured 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.
• Positive urine cotinine (≥ 500 ng/mL) at Screening.
• Willing to comply with the requirements of the study.
• Willing to use all test products after product trial at Check in.
• Willing and able to abstain from cigarettes from Day 1 through the End of the study.

You may not qualify if…

• Use of any type of tobacco or nicotine containing products other than manufactured cigarettes (e.g., e vapor products, roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) in the 7 days prior to Check in
• Self-reported puffers (i.e., adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).
• Planning to quit smoking in the next 30 days (from Screening visit).
• History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, existing respiratory diseases, immunologic, psychiatric, lymphatic, 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, medical history, ECG, or clinical laboratory results, in the opinion of the Investigator.

Where it is running

• QPS Bio-Kinetic Clinical Applications, LLC — Springfield, Missouri, United States
• Inflamax - Hill Top Research — Neptune City, New Jersey, United States

Full record on ClinicalTrials.gov

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