Tobacco UseNCT05664672
Study to Evaluate Changes in Smokers Using on!® Nicotine Pouches
A study testing OTDN Product 1, OTDN Product 2 and OTDN Product 3 in people with Tobacco Use, run by Altria Client Services LLC at 3 sites in United States.
Trial summary
The purpose of this study is to generate evidence regarding the extent of reduction in exposure to selected HPHCs in adult smokers switching to on!® NPs. The study intends to determine changes in exposure to selected HPHCs by measuring biomarkers in adult smokers who completely switch from smoking to use of on!® NP… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- OTDN Product 1, OTDN Product 2 and OTDN Product 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 May 2021to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary consent to participate in this study documented on the signed ICF
- Smoking history (self-reported at screening) of an average of at least 10 but no more than 30 factory-manufactured combustible cigarettes (either menthol or non-menthol) daily for at least 12 months prior to screening. Brief periods (ie, up to 7 consecutive days) of non-smoking during the 3 months prior to screening (eg, due to illness or participation in a study where smoking was prohibited) will be permitted
- Positive urine cotinine (≥ 500 ng/mL) at screening
- Female subjects who are heterosexually active and of childbearing potential (eg, neither surgically sterile at least 6 months prior to check-in nor postmenopausal with amenorrhea for at least 12 months prior to check-in with follicle-stimulating hormone [FSH] levels consistent with postmenopausal status) must have been using one of the following forms of contraception for the time period indicated and agree to continue using it through completion of the study:
- Hormonal (eg, oral, vaginal ring, transdermal patch, implant, injection) consistently for at least 3 months prior to check-in, double barrier (ie, condom with spermicide or diaphragm with spermicide) consistently for at least 4 weeks prior to check-in, an intrauterine device for at least 4 months prior to check-in
- Exclusive partner who has been vasectomized for at least 6 months (inclusive) prior to check-in
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- 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 (including Essure® or similar nonsurgical sterilization procedures); bilateral tubal ligation or bilateral salpingectomy; hysterectomy; bilateral oophorectomy
- Or be postmenopausal with amenorrhea for at least 12 months prior to check-in and have FSH levels consistent with postmenopausal status
- Willing to comply with the requirements of the study
- Willing to use all 3 on!® NP after the Product Trial at check-in
- Willing and able to abstain from cigarettes from Day 1 through the end of the study (EOS)
- Healthy adult males and females, 21 to 65 years of age, inclusive at screening, with subjects aged 46 to 65 years being fully vaccinated for COVID-19 (SARS-CoV-2) at least 14 days before the screening visit.
Who cannot join
- Use of any type of tobacco- or nicotine-containing products other than manufactured cigarettes (eg, 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 (ie, 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, electrocardiogram (ECG), or clinical laboratory results, in the opinion of the investigator
- Positive test for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus at screening
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- History or presence of any type of malignant tumors
- Current evidence or any history of congestive heart failure
- Diabetes mellitus (fasting glucose ≥126 mg/L [7 mmol/L]) that is not controlled by diet/exercise alone, in the opinion of the investigator
- An acute illness (eg, upper respiratory infection, viral infection) requiring treatment with prescribed medicines within 2 weeks prior to check-in
- Dentition that prevents subjects from using on!® NP products
- Allergic to or cannot tolerate mint flavoring agents or phenylalanine
- Any planned surgery from the time of screening through EOS
- History of drug or alcohol abuse within 24 months prior to check-in
- Fever (ie, body temperature >100.5°F) at screening or check-in. One recheck may be performed at the investigator's discretion
- Body mass index greater than 40.0 kg/m2 or less than 18.0 kg/m2 at screening
- Systolic blood pressure >150 mmHg and/or diastolic blood pressure > 90 mmHg at screening or check-in, measured after being seated for at least 5 minutes. One recheck may be performed at the investigator's discretion
- Estimated creatinine clearance (by Cockcroft-Gault equation) < 80 mL/minute at screening
- Serum alanine aminotransferase ≥1.5 times the upper limit of normal and/or aspartate aminotransferase ≥1.5 times the upper limit of normal at screening
- Positive screen for alcohol (breath) or any of the following drugs of abuse (urine), regardless of the reason of use: amphetamines, methamphetamines, opiates, cannabinoids, or cocaine at screening or check-in
- Female subjects who are pregnant (positive serum pregnancy test at screening or urine pregnancy test at check-in), lactating, or intend to become pregnant from screening through EOS
- Use of prescription or over-the-counter bronchodilator medication (eg, inhaled or oral ß-agonists) within 12 months prior to check-in
- Use of medications or foods known or are suspected to interact with cytochrome P450 2A6 (including, but not limited to, amiodarone, amlodipine, amobarbital, buprenorphine, clofibrate, clotrimazole, desipramine, disulfiram, entacapone, fenofibrate, isoniazid, grapefruit, ketoconazole, letrozole, methimazole, methoxsalen, metyrapone, miconazole, modafinil, orphenadrine, pentobarbital, phenobarbital, pilocarpine, primidone, propoxyphene, quinidine, rifampicin, rifampin, secobarbital, selegiline, sulconazole, tioconazole, tranylcypromine) within 14 days or 5 half-lives of the drug, whichever is longer, prior to check-in or during the study
- Use of antibiotic treatment within 2 weeks prior to check-in
- Plasma donation within 7 days prior to check-in
- Donation of blood or blood products (with the exception of plasma as noted above), had significant blood loss, or received whole blood or a blood product transfusion within 56 days prior to check-in
- Participation in a previous clinical study for an investigational drug, device, biologic, or a tobacco product within 30 days prior to check-in
- Participation in 2 or more Altria Client Services (ALCS) studies within the past 12-month period prior to check-in
- Subject or a first-degree relative (ie, parent, sibling, child, spouse/partner) is a current or former employee of the tobacco industry or a named party or class representative in litigation with any tobacco company
- Subject or a first-degree relative (ie, parent, sibling, child, spouse/partner) is a current employee of the study site
- Positive result for coronavirus disease (COVID)-19 (SARS-CoV-2) test at screening or check-in
- One or more "yes" answers to any of the questions on the COVID-19 (SARS-CoV-2) screening questionnaire (provided by the study site) at screening or check-in.
- Have been diagnosed with major depressive disorder or have a history of suicide attempt.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NOCCR
Knoxville, Tennessee, 37920
CKRA
Lexington, Kentucky, 40509
QPS
Springfield, Missouri, 65802
About this study
Official title: A Randomized, Controlled, Open-label Short-term Study to Evaluate Changes in Exposure to Harmful and Potentially Harmful Constituents in Adult Smokers Who Completely Switch to on!® Nicotine Pouches in a Clinical Setting
The purpose of this study is to generate evidence regarding the extent of reduction in exposure to selected HPHCs in adult smokers switching to on!® NPs. The study intends to determine changes in exposure to selected HPHCs by measuring biomarkers in adult smokers who completely switch from smoking to use of on!® NP compared to those who continue smoking cigarettes or stop using all tobacco products.
Read the detailed description
This is an open-label, randomized, 5 parallel-group clinical study evaluating changes in exposure to selected harmful and potentially harmful constituents (HPHCs) and product use behavior in adult smokers who are randomly assigned to 1 of the 5 groups; continue smoking, partially or completely switch to oral tobacco-derived nicotine products, or stop using any tobacco products for 7 days.
- Conditions
- Tobacco Use
- Being tested
- OTDN Product 1, OTDN Product 2, OTDN Product 3, No Tobacco
- Keywords
- Tobacco, Smoking
- Medical subject headings
- Tobacco Use, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTDN Product 1Other
Mint on!® 2 mg nicotine pouches
OTDN Product 2Other
Mint on!® 4 mg nicotine pouches
OTDN Product 3Other
Mint on!® 8 mg nicotine pouches
No TobaccoOther
subjects completely stop all tobacco product usage for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (CC) | No intervention | Subjects will be asked to continue smoking their UBCs ad libitum for 7 days. |
| Group 2 (NP2) | Experimental | Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days. Receives: Other: OTDN Product 1 |
| Group 3 (NP4) | Experimental | Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days. Receives: Other: OTDN Product 2 |
| Group 4 (NP8) | Experimental | Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days. Receives: Other: OTDN Product 3 |
| Group 5 (NT) | Experimental | Subjects will completely stop all tobacco product usage for 7 days. Receives: Other: No Tobacco |
What is being measured
The primary outcome is the main question the study is designed to answer.
NNAL Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
Secondary outcomes (23)
NE Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted Nicotine Equivalents (NE) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during the 24 hours was converted to 24-hour urine volume using the assumed density of 1 gram (g) equals 1 milliliter (mL).
The amount of biomarker was calculated as follows:
NE concentration (μg/mL) = (nicotine [ng/mL]/162.23 [mg/mmol] + nicotine-gluc [ng/mL]/338.36 [mg/mmol] + cotinine [ng/mL]/176.22 [mg/mmol] + cotinine-gluc [ng/mL]/352.34 [mg/mmol] + trans-3'-hydroxycotinine [ng/mL]/192.22 [mg/mmol] + trans-3'-hydroxycotinine-gluc [ng/mL]/368.34 [mg/mmol]) × 162.23 (mg/mmol) × 1 μg/1000 ng
Adjusted Nicotine equivalents (mg NE/g creatinine) = NE concentration (μg/mL) × 100 / Creatinine concentration (mg/dL)
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
2-AN Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted 2-aminonaphthalene (2-AN) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
4-ABP Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted 4-aminobiphenyl (4-ABP) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
HEMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted 2-hydroxyethylmercapturic acid (HEMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
CEMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted cyanoethylmercapturic acid (CEMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
SPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted S-phenylmercapturic acid (SPMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
HMPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted 3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
3-HPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted 3-hydroxypropylmercapturic acid (3-HPMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
2-HPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted 2-hydroxypropylmercapturic acid (2-HPMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
AAMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted N-acetyl-S-(2-carbamoylethyl) cysteine (AAMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
GAMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted N-acetyl-S-(2-carbamoyl-2-hydroxyethyl)-1-cysteine (GAMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
2-MHBMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted 2-hydroxybutenylmercapturic acid (2-MHBMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
2-OH-Flu Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted 2-OH-Fluorene (2-OH-Flu) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
2-OH-Nap Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted 2-Naphthol (2-OH-Nap) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
1-OH-Phe Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted 1-OH-Phenanthrene (1-OH-Phe) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
3-OH-B[a]P Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted 3-hydroxybenzo[a]pyrene (3-OH-B[a]P) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
Urine Mutagenicity Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urine mutagenicity (Rev/24h) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
250 mL urine sample will be concentrated to 1 mL and used for urine mutagenicity testing.
Measurement results are reported as revertants/μL. Urine mutagenicity count in the 24-hour urine was calculated as:
Urine mutagenicity (revertants/250 mL) = Urine mutagenicity (revertants/μL) x 1000V, where V is the volume after concentration in mL
Urine mutagenicity (revertants/24 hour) = Urine mutagenicity (revertants/250 mL) x [24h urine volume(mL) ÷ V], where V is the volume in mL of urine sample used for the mutagenicity test
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
1-OH-Pyr Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of 24-hour urinary creatinine-adjusted 1-hydroxypyrene (1-OH-Pyr) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL
Amount of biomarker was calculated as:
Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng
Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng
The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows:
Absolute change from baseline = Post Randomization Value - Baseline Value
Measured: Samples collected over 24 hours on Day -1 (baseline) and Day 7
Carboxyhemoglobin (COHb) Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Summary of blood carboxyhemoglobin (%) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days.
The absolute change from baseline of urine biomarker amount excreted in 24 hours and blood biomarker concentration will be calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value where Baseline = Day -1
Measured: Samples collected at approximately 21:30 on Day -1 (baseline) and Day 7
Summary of Cigarettes Smoked Per Day (CPD)
The number of cigarettes smoked per day (CPD) from 07:00 to 23:00 on Day 1 to Day 7 was collected to assess produce use behavior. Subjects in NP2, NP4, NP8 and NT groups were not allowed to use cigarettes starting at Day 1.
Measured: Data was collected from 07:00 to 23:00 each day starting from Day 1 to Day 7/end of study
Summary of Total Number of Nicotine Pouches Used Per Day (NPPD)
The number of nicotine pouches used per day (NPPD) from 07:00 to 23:00 on Day 1 to Day 7 was collected to assess produce use behavior. Only subjects in NP2, NP4 and NP8 groups used nicotine pouches during the study.
Measured: Data was collected from 07:00 to 23:00 each day starting from Day 1 to Day 7/end of study
Summary of Average Number of Nicotine Pouches Per Use
The average number of nicotine pouches per use occasion (NPPU) from 07:00 to 23:00 on Day 1 to Day 7 was collected to assess produce use behavior. Only subjects in NP2, NP4 and NP8 groups used nicotine pouches during the study.
Measured: Data was collected from 07:00 to 23:00 each day starting from Day 1 to Day 7/end of study
Summary of Average Duration of Each Nicotine Pouch Use
The average duration (in minutes) of each nicotine pouch use from 07:00 to 23:00 on Day 1 to Day 7 was collected to assess produce use behavior. Only subjects in NP2, NP4 and NP8 groups used nicotine pouches during the study.
Measured: Data was collected from 07:00 to 23:00 each day starting from Day 1 to Day 7/end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start11 May 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altria Client Services LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- William J Howitt, MD, Principal investigator, QPS Holdings LLCWilliam Smith, MD, Principal investigator, NOCCRMark Adams, MD, Principal investigator, CKRA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664672
- Sponsor's protocol ID
- ALCS-REG-20-15-OTDN
- Status last verified
- Oct 2024
- First submitted
- 16 Dec 2022
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label Short-term Study to Evaluate Changes in Exposure to Harmful and Potentially Harmful Constituents in Adult Smokers Who Completely Switch to on!® Nicotine Pouches in a Clinical Setting
- ClinicalTrials.gov ID
- NCT05664672
- Acronym / sponsor ID
- ALCS-REG-20-15-OTDN
- Conditions
- Tobacco Use
- Keywords
- Tobacco, Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Altria Client Services LLCIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 11 May 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to generate evidence regarding the extent of reduction in exposure to selected HPHCs in adult smokers switching to on!® NPs. The study intends to determine changes in exposure to selected HPHCs by measuring biomarkers in adult smokers who completely switch from smoking to use of on!® NP compared to those who continue smoking cigarettes or stop using all tobacco products.
Detailed description
This is an open-label, randomized, 5 parallel-group clinical study evaluating changes in exposure to selected harmful and potentially harmful constituents (HPHCs) and product use behavior in adult smokers who are randomly assigned to 1 of the 5 groups; continue smoking, partially or completely switch to oral tobacco-derived nicotine products, or stop using any tobacco products for 7 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 (CC) | No intervention | –Subjects will be asked to continue smoking their UBCs ad libitum for 7 days. |
| Group 2 (NP2) | Experimental | Other: OTDN Product 1Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days. |
| Group 3 (NP4) | Experimental | Other: OTDN Product 2Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days. |
| Group 4 (NP8) | Experimental | Other: OTDN Product 3Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days. |
| Group 5 (NT) | Experimental | Other: No TobaccoSubjects will completely stop all tobacco product usage for 7 days. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Voluntary consent to participate in this study documented on the signed ICF
- Smoking history (self-reported at screening) of an average of at least 10 but no more than 30 factory-manufactured combustible cigarettes (either menthol or non-menthol) daily for at least 12 months prior to screening. Brief periods (ie, up to 7 consecutive days) of non-smoking during the 3 months prior to screening (eg, due to illness or participation in a study where smoking was prohibited) will be permitted
- Positive urine cotinine (≥ 500 ng/mL) at screening
- Female subjects who are heterosexually active and of childbearing potential (eg, neither surgically sterile at least 6 months prior to check-in nor postmenopausal with amenorrhea for at least 12 months prior to check-in with follicle-stimulating hormone [FSH] levels consistent with postmenopausal status) must have been using one of the following forms of contraception for the time period indicated and agree to continue using it through completion of the study:
- 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.
Key exclusion criteria (33 listed)
- Use of any type of tobacco- or nicotine-containing products other than manufactured cigarettes (eg, 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 (ie, 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, electrocardiogram (ECG), or clinical laboratory results, in the opinion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTDN Product 1Mint on!® 2 mg nicotine pouches | Other | Group 2 (NP2) |
| OTDN Product 2Mint on!® 4 mg nicotine pouches | Other | Group 3 (NP4) |
| OTDN Product 3Mint on!® 8 mg nicotine pouches | Other | Group 4 (NP8) |
| No Tobaccosubjects completely stop all tobacco product usage for 7 days | Other | Group 5 (NT) |
Primary outcome
NNAL Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
Summary of 24-hour urinary creatinine-adjusted total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration [unit1/mL] × 24h urine volume [mL] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
23 secondary outcomes
NE Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
2-AN Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
4-ABP Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
HEMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
CEMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
SPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
HMPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
3-HPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
2-HPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
AAMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
GAMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
2-MHBMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
2-OH-Flu Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
2-OH-Nap Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
1-OH-Phe Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
3-OH-B[a]P Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
Urine Mutagenicity Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
1-OH-Pyr Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7
Carboxyhemoglobin (COHb) Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Time frame: Samples collected at approximately 21:30 on Day -1 (baseline) and Day 7
Summary of Cigarettes Smoked Per Day (CPD)
Time frame: Data was collected from 07:00 to 23:00 each day starting from Day 1 to Day 7/end of study
Summary of Total Number of Nicotine Pouches Used Per Day (NPPD)
Time frame: Data was collected from 07:00 to 23:00 each day starting from Day 1 to Day 7/end of study
Summary of Average Number of Nicotine Pouches Per Use
Time frame: Data was collected from 07:00 to 23:00 each day starting from Day 1 to Day 7/end of study
Summary of Average Duration of Each Nicotine Pouch Use
Time frame: Data was collected from 07:00 to 23:00 each day starting from Day 1 to Day 7/end of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William J Howitt, MD principal investigator
QPS Holdings LLC
William Smith, MD principal investigator
NOCCR
Mark Adams, MD principal investigator
CKRA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTDN Product 1, OTDN Product 2 and OTDN Product 3 in people with Tobacco Use, run by Altria Client Services LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NNAL Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days (time frame: Samples collected over 24 hours on Day -1 (baseline) and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.