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OpenTrials
Completed

NCT Number: NCT03692078

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

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.

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Key information

Conditions

Tobacco Use Behavior

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QPS Bio-Kinetic Clinical Applications, LLC, Springfield, Missouri, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

OTDN Product 1

Other

Oral tobacco-derived nicotine product

OTDN Product 2

Other

Oral tobacco-derived nicotine product

Tobacco Cessation

Other

Tobacco Cessation

Primary outcomes

  1. Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the lower limit of quantitation (LLOQ) (2.00 pg/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  2. Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.00 pg/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

Secondary outcomes

  1. Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of N-nitrosonornicotine (NNN) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.500 pg/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  2. Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of N-nitrosonornicotine (NNN) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.500 pg/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  3. Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of nicotine equivalents amount excreted (mg/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) for each metabolite were set to one-half of the LLOQ for the calculation of nicotine equivalents. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Nicotine equivalents (mg/g creatinine) = nicotine equivalents (μg/mL) x 100 / creatinine (mg/dL)

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  4. Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of nicotine equivalents amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) for each metabolite were set to one-half of the LLOQ for the calculation of nicotine equivalents. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Nicotine equivalents (mg/g creatinine) = nicotine equivalents (μg/mL) x 100 / creatinine (mg/dL)

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  5. Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of 2-aminonaphthalene (2-AN) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.7 pg/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  6. Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of 2-aminonaphthalene (2-AN) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.7 pg/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  7. Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of 4-aminobiphenyl (4-ABP) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.5 pg/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  8. Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of 4-aminobiphenyl (4-ABP) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.5 pg/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  9. Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of 2-hydroxyethyl mercapturic acid (HEMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.2 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  10. Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of 2-hydroxyethyl mercapturic acid (HEMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.2 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  11. Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of 2-cyanoethylmercapturic acid (CEMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.25 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  12. Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of 2-cyanoethylmercapturic acid (CEMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.25 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  13. Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of S-phenyl mercapturic acid (S-PMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.02 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  14. Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of S-phenyl mercapturic acid (S-PMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.02 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  15. Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of 3-hydroxy-1-methylpropylmercapturic acid (3-HMPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (5 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  16. Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of 3-hydroxy-1-methylpropylmercapturic acid (3-HMPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (5 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  17. Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of 3-hydroxypropylmercapturic acid (3-HPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (25 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  18. Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of 3-hydroxypropylmercapturic acid (3-HPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (25 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  19. Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of 2-hydroxypropyl-mercapturic acid (2-HPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.5 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  20. Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of 2-hydroxypropyl-mercapturic acid (2-HPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.5 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  21. Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of N-acetyl-S-(2-carbamoylethyl)-l-cysteine (AAMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (10 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  22. Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of N-acetyl-S-(2-carbamoylethyl)-l-cysteine (AAMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (10 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  23. Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of N-acetyl-S-(2-carbamoyl-2-hydroxyethyl)-l-cysteine (GAMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  24. Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of N-acetyl-S-(2-carbamoyl-2-hydroxyethyl)-l-cysteine (GAMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  25. Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of 2-hydroxybutenyl-mercapturic acid (2-MHBMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.129 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  26. Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of 2-hydroxybutenyl-mercapturic acid (2-MHBMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.129 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  27. Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of 2-OH-Fluorene (2-OHFLe) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.1 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  28. Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of 2-OH-Fluorene (2-OHFLe) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.1 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  29. Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of 2-Naphthol amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.10 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  30. Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of 2-Naphthol amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.10 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  31. Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of 1-OH-Phenanthrene (1-OHPhe) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.005 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  32. Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of 1-OH-Phenanthrene (1-OHPhe) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.005 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  33. Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of 1-hydroxypyrene (1-OHP) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.01 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  34. Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of 1-hydroxypyrene (1-OHP) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.01 ng/mL) for summarization and statistical analysis. Baseline = Day -1.

    24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void).

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  35. Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of urine mutagenicity (revertants/24 hours) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Baseline = Day -1.

    250 mL urine sample will be concentrated to 1 mL and used for urine mutagenicity testing. The measurement results will be reported as revertants/μL. The urine mutagenicity count in the 24 hour urine will be calculated as: Urine mutagenicity (revertants/24 hour) = Urine mutagenicity (revertants/250 mL) x urine volume/ urine sample volume in mL

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  36. Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of urine mutagenicity percent change from Baseline (%) by study group and study day is presented. Baseline = Day -1.

    250 mL urine sample will be concentrated to 1 mL and used for urine mutagenicity testing. The measurement results will be reported as revertants/μL. The urine mutagenicity count in the 24 hour urine will be calculated as: Urine mutagenicity (revertants/24 hour) = Urine mutagenicity (revertants/250 mL) x urine volume/ urine sample volume in mL

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  37. Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population)

    Time frame: Baseline (Day -1), Day 5 and Day 7

    Summary of whole blood carboxyhemoglobin [COHb] (% saturation) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Baseline = Day -1.

    The blood sample for COHb was collected approximately 21:30 on Days -1, 5, and 7 after subjects abstained from product use, as appropriate, for at least 15 minutes prior to blood draw for COHb.

    Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value

  38. Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)

    Time frame: Day 5 and Day 7

    Summary of whole blood carboxyhemoglobin (COHb) percent change from Baseline (%) is presented. Subjects with valid sample results are included. Baseline = Day -1.

    The blood sample for COHb was collected approximately 21:30 on Days -1, 5, and 7 after subjects abstained from product use, as appropriate, for at least 15 minutes prior to blood draw for COHb.

    % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %

  39. Cigarette Consumption by Study Group and Study Day (mITT Population)

    Time frame: Day -1 and Day -2 (Baseline), Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7

    Summary of cigarette consumption, as number of cigarettes smoked per day (CPD), by study group and study day is presented. Baseline = Average of Days -2 and -1.

  40. Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population)

    Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7

    Summary of VERVE® Product Used Per Day by Study Group and Study Day is presented. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall).

  41. Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population)

    Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7

    Summary of average VERVE® product use duration (minutes) by Study Group and Study Day is presented. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall).

  42. Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population)

    Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7

    Summary of total duration (minutes) of VERVE® product per day by Study Group and Study Day. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall).

  43. Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population)

    Time frame: Data collected on Day 7 at 21:30 (±30 minutes) during the product use period

    Summary of subject responses to "Use the Product (Cigarette) Again" Bipolar Visual Analogue Scale (VAS) Scores for cigarettes is presented. The Use the Product Again Bipolar VAS is a 100 mm scale ranging from 0 mm ("Definitely Would Not") to 100 mm ("Definitely Would"). The bipolar score is calculated by subtracting 50 from the original VAS score, then categorizing into three categories: -50 to <0, 0, and >0 to 50. Higher scores are associated with greater willingness to use the cigarettes again. Mean and standard deviation of the bipolar VAS score per category is shown.

    The "Use the Product Again" VAS Score was given to subjects on Day 7 at 21:30 (±30 minutes) during the product use period.

    The data shown are the means calculated from only those participants with scores in the corresponding category ('-50 to <0', '0' and '>0 to 50').

  44. Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population)

    Time frame: Data collected on Day 7 at 21:30 (±30 minutes) during the product use period

    Summary of subject responses to "Use the Product (VERVE®) Again" Bipolar Visual Analogue Scale (VAS) Scores for the VERVE® test products are presented. The Use the Product Again Bipolar VAS is a 100 mm scale ranging from 0 mm ("Definitely Would Not") to 100 mm ("Definitely Would"). The bipolar score is calculated by subtracting 50 from the original VAS score, then categorizing into three categories: -50 to <0, 0, and >0 to 50. Higher scores are associated with greater willingness to use the VERVE® product again. Mean and standard deviation of the bipolar VAS score per category is shown.

    The "Use the Product Again" VAS Score was given to subjects on Day 7 at 21:30 (±30 minutes) during the product use period.

    The data shown are the means calculated from only those participants with scores in the corresponding category ('-50 to <0', '0' and '>0 to 50').

Sponsors and collaborators

Lead sponsor

Altria Client Services LLC

Industry

Registry information

Official study title

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.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 2, 2018
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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