N/A
N=149
Study to Evaluate Changes in Smokers Using on!® Nicotine Pouches
Tobacco Use
Bottom Line
View on ClinicalTrials.gov: NCT05664672 ↗Enrolled (actual)
149
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: NNAL Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days — 363; 274; 312; 293 ng/g — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OTDN Product 1 (Other); OTDN Product 2 (Other); OTDN Product 3 (Other); No Tobacco (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Altria Client Services LLC
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NNAL Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
363; 274; 312; 293; 392; 330 | <.0001 sig |
| SECONDARY NE Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
11.6; 8.73; 10.3; 10.5; 12.2; 10.4 | 0.0994 |
| SECONDARY 2-AN Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
21.7; 17.0; 21.6; 19.8; 20.6; 20.2 | <.0001 sig |
| SECONDARY 4-ABP Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
13.8; 10.2; 13.3; 12.8; 12.8; 13.2 | <.0001 sig |
| SECONDARY HEMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
5.19; 2.98; 5.64; 5.65; 3.90; 4.63 | <.0001 sig |
| SECONDARY CEMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
163; 133; 154; 170; 160; 150 | <.0001 sig |
| SECONDARY SPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
4.41; 3.03; 3.90; 3.79; 3.54; 4.14 | <.0001 sig |
| SECONDARY HMPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
371; 303; 325; 338; 353; 345 | <.0001 sig |
| SECONDARY 3-HPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
1250; 969; 1160; 1170; 1200; 1170 | <.0001 sig |
| SECONDARY 2-HPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
52.7; 39.2; 47.3; 45.4; 41.4; 50.9 | <.0001 sig |
| SECONDARY AAMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
92.6; 82.6; 95.6; 94.0; 94.3; 87.7 | <.0001 sig |
| SECONDARY GAMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
14.4; 13.1; 14.3; 14.7; 14.1; 14.1 | <.0001 sig |
| SECONDARY 2-MHBMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
1.93; 1.24; 1.60; 1.47; 1.26; 1.74 | <.0001 sig |
| SECONDARY 2-OH-Flu Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
2.24; 1.71; 2.01; 2.14; 2.08; 2.08 | <.0001 sig |
| SECONDARY 2-OH-Nap Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
11.1; 11.5; 12.6; 13.8; 11.8; 10.6 | <.0001 sig |
| SECONDARY 1-OH-Phe Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
0.218; 0.162; 0.172; 0.171; 0.191; 0.203 | <.0001 sig |
| SECONDARY 3-OH-B[a]P Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
216; 139; 223; 172; 166; 246 | <.0001 sig |
| SECONDARY Urine Mutagenicity Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
13300; 8770; 9170; 7580; 12000; 10800 | <.0001 sig |
| SECONDARY 1-OH-Pyr Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
0.208; 0.148; 0.145; 0.174; 0.174; 0.198 | <.0001 sig |
| SECONDARY Carboxyhemoglobin (COHb) Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days |
11.8; 10.3; 11.3; 11.1; 11.0; 11.3 | <.0001 sig |
| SECONDARY Summary of Cigarettes Smoked Per Day (CPD) |
16.1; 15.8; 15.6; 14.8; 15.8; 15.8 | — |
| SECONDARY Summary of Total Number of Nicotine Pouches Used Per Day (NPPD) |
9.78; 9.77; 7.27; 9.22; 10.2; 6.93 | — |
| SECONDARY Summary of Average Number of Nicotine Pouches Per Use |
1.19; 1.22; 1.09; 1.22; 1.28; 1.15 | — |
| SECONDARY Summary of Average Duration of Each Nicotine Pouch Use |
23.5; 22.4; 19.1; 25.1; 25.1; 21.6 | — |
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 compared to those who continue smoking cigarettes or stop using all tobacco products.
Eligibility Criteria
Inclusion Criteria
- 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
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.
Exclusion Criteria
- 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
- History or presence of any type of malignant tumors
- Current evidence or any history of congestive heart failure
- Diabetes mellit
Data sourced from ClinicalTrials.gov (NCT05664672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.