Effects of an Oral Nicotine Product in Smokeless Tobacco Users

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-23

Study Completion Date

2023-11-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this research study is to find out how three different nicotine pouches and participant's own brand of smokeless tobacco affect blood nicotine levels and how participants feel.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Nicotine Pouch Characteristics on Perceptions and Behavior

NCT06597435

Nicotine Pouch Self-Administration

RECRUITING NA

Acute Effects of Oral Nicotine Pouches

NCT07128329

Nicotine Pouch Self-Administration Nicotine Pharmacokinetic Study Nicotine Pharmacodynamic Study

RECRUITING PHASE1

Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]

NCT05030194

Tobacco Use Tobacco Smoking Cigarette Smoking +1 more

COMPLETED NA

Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users

NCT03710590

Electronic Cigarettes

COMPLETED NA

Randomized Controlled Trial to Evaluate the Impact of ZYN Nicotine Pouch Products on Cigarette Usage and BoExp in Adult Smokers Over a 12-week Period

NCT06568900

Tobacco Use

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single arm design

On four separate occasions, participants will come to the research center and be asked to use a nicotine pouch or smokeless tobacco provided by the study team two separate times. The nicotine pouches or smokeless tobacco contain different amounts of nicotine. Participants will not know the concentration of nicotine in the nicotine pouch, but they will know the concentration and brand of the smokeless tobacco (it will be their usual brand). All participants will complete all four study conditions.

Group Type EXPERIMENTAL

oral nicotine pouch - 2 mg

Intervention Type OTHER

"On" brand oral nicotine pouch with 2 mg of protonated nicotine in "original" flavor

oral nicotine pouch - 4 mg

Intervention Type OTHER

"On" brand oral nicotine pouch with 4 mg of protonated nicotine in "original" flavor

oral nicotine pouch - 8 mg

Intervention Type OTHER

"On" brand oral nicotine pouch with 8 mg of protonated nicotine in "original" flavor

Smokeless tobacco

Intervention Type OTHER

Participant's typical brand of smokeless tobacco

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

oral nicotine pouch - 2 mg

"On" brand oral nicotine pouch with 2 mg of protonated nicotine in "original" flavor

Intervention Type OTHER

oral nicotine pouch - 4 mg

"On" brand oral nicotine pouch with 4 mg of protonated nicotine in "original" flavor

Intervention Type OTHER

oral nicotine pouch - 8 mg

"On" brand oral nicotine pouch with 8 mg of protonated nicotine in "original" flavor

Intervention Type OTHER

Smokeless tobacco

Participant's typical brand of smokeless tobacco

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy (determined by self-report)
* Between the ages of 18-55
* Willing to provide informed consent, attend the lab sessions and abstain from tobacco/nicotine as required
* Agree to use designated products according to study protocol
* Smokeless tobacco users and must report using smokeless tobacco daily. Smokeless tobacco users must have a 'positive' cotinine cassette result to verify nicotine use

Exclusion Criteria

* The following self-reported current, diagnosed medical condition(s): heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures
* Other self-reported current, diagnosed medical conditions (e.g., diabetes, thyroid disease, Lyme disease) may be excluded after consultation with the PI and medical monitor: any medical condition/medication that may affect participant safety, study outcomes, or biomarker data will be excluded based on these consultations
* Self-reported current, diagnosed psychiatric conditions, and who are currently under the care of a physician for psychiatric conditions, or who report current psychiatric treatment or psychotropic medication use
* Breast-feeding or pregnant women (pregnancy tested by urinalysis at screening
* Weigh less than 110 pounds
* Intend to quit tobacco/nicotine use in the next 30 days

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes