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



Status:Completed
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:21 - 65
Updated:10/18/2018
Start Date:May 30, 2018
End Date:October 1, 2018

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A Randomized, Controlled, Study to Evaluate Changes in Exposure to Harmful and Potentially Harmful Constituents in Adult Smokers Who Partially or Completely Switch to Oral Tobacco-derived Nicotine Products in a Clinical Setting.

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.

This is an open label, randomized, 6 parallel-group clinical study evaluating changes in
exposure to selected HPHCs, subjective effects, and product use behavior in adult smokers
relative to continued smoking who are randomly assigned to continue smoking, partially or
completely switch to oral tobacco-derived nicotine products, or stop using any tobacco
products for 7 days.

Inclusion Criteria:

1. Voluntary consent to participate in this study documented on the signed informed
consent form (ICF).

2. Healthy adult males and females 21 to 65 years of age, inclusive, at Screening

3. 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.

4. Positive urine cotinine (≥ 500 ng/mL) at Screening.

5. Willing to comply with the requirements of the study.

6. Willing to use all test products after product trial at Check in.

7. Willing and able to abstain from cigarettes from Day 1 through the End of the study.

Exclusion Criteria:

1. 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

2. Self-reported puffers (i.e., adult smokers who draw smoke from the cigarette into the
mouth and throat but do not inhale).

3. Planning to quit smoking in the next 30 days (from Screening visit).

4. 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.

5. Clinically significant abnormal findings on the vital signs, physical examination,
medical history, ECG, or clinical laboratory results, in the opinion of the
Investigator.
We found this trial at
2
sites
Neptune, New Jersey 07753
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Neptune, NJ
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Springfield, Missouri 65802
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Springfield, MO
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