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

Altria Client Services

Status: Completed

Conditions: Tobacco Use

Treatments: Other: Tobacco Cessation; Other: OTDN product 1; Other: OTDN product 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03692078

ALCS-RDS-18-04-VRV

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 231 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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231 participants in 6 patient groups

GROUP 1: Continue Smoking

No Intervention group

Description:

Subjects will be asked to continue smoking their own brand (OB) cigarettes ad libitum for 7 days.

GROUP 2: OTDN product 1

Experimental group

Description:

Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline cigarettes per day (CPD) and use at least 3 oral tobacco-derived nicotine (OTDN) product units per day for 7 days.

Treatment:

Other: OTDN product 1

GROUP 3: OTDN product 2

Experimental group

Description:

Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 oral tobacco-derived nicotine (OTDN) product units per day for 7 days.

Treatment:

Other: OTDN product 2

GROUP 4: OTDN product 1

Experimental group

Description:

Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine (OTDN) product, using at least 3 OTDN product units per day for 7 days.

Treatment:

Other: OTDN product 1

GROUP 5: OTDN product 2

Experimental group

Description:

Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine (OTDN) product, using at least 3 OTDN product units per day for 7 days.

Treatment:

Other: OTDN product 2

GROUP 6: Tobacco Cessation

Experimental group

Description:

Subjects will completely stop all tobacco product usage for 7 days.

Treatment:

Other: Tobacco Cessation