Understanding Oral Nicotine Pouch Use in Healthy Volunteers

NCT07829939 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY00000041R01DA065785
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to understand how using oral nicotine pouches effects the body in healthy volunteers. The main questions it aims to answer are:

• use 3 different strengths of ONPs (0 mg, 3 mg, 6 mg) and their usual inhaled nicotine product (cigarette or e-cigarette/vape)
• visit the hospital research ward on 4 separate days for 8 hours each day
• use one of each of the products in a randomized order (by chance, like flipping a coin) on each of the 4 hospital study days

Conditions

Healthy Adult Participants

Keywords

oral nicotine pouches; nicotine

Outcome Measures

Primary Outcomes (1)

• With multiple use of ONPs throughout the day, participants will titrate their intake of nicotine to be similar to or higher than that seen with cigarette smoking or vaping.

  This will be assessed by comparing ratios of nicotine area under the plasma nicotine concentration time curve.

  7 hours post-dose

Secondary Outcomes (2)

• With multiple use of ONPs throughout the day, participants will experience satisfaction, psychological reward and relief of withdrawal symptoms similar to that seen with cigarette smoking or vaping.

  Pre-dose until 7 hours post-dose.

• Cardiovascular effects among arms using heart rate as a measure

  Pre-dose until 7 hours post-dose

Study Arms (4)

Placebo

PLACEBO COMPARATOR

placebo (0 mg nicotine pouches) used on one study day (8 hours)

Drug: 0 mg oral nicotine pouches

3 mg ONP

EXPERIMENTAL

3 mg oral nicotine pouches used on one study day (8 hours)

Drug: 3 mg oral nicotine pouches

6 mg ONP

EXPERIMENTAL

6 mg oral nicotine pouches used on one study day (8 hours)

Drug: 6 mg oral nicotine pouches

Inhaled nicotine

EXPERIMENTAL

Participants will use their own brand of either cigarettes or e-cigarettes (vapes) on one study day (8 hours)

Drug: cigarette or e-cigarette

Interventions

0 mg oral nicotine pouches DRUG

placebo

Placebo

3 mg oral nicotine pouches DRUG

low strength oral nicotine pouches

3 mg ONP

6 mg oral nicotine pouches DRUG

high strength oral nicotine pouches

6 mg ONP

cigarette or e-cigarette DRUG

Participants will use their own cigarette or e-cigarette (vape)

Inhaled nicotine

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy based on medical history and limited physical examination.
• Heart rate \< 105 BPM\*
• Systolic Blood Pressure \< 160 and \> 90\*
• Diastolic Blood Pressure \< 100 and \> 50\*
• \*Considered out of range if both machine and manual readings are above/below these thresholds.
• Body Mass Index ≤ 38.0
• Willingness to abstain from illicit drug use for the duration of the study and cannabis for 48 hours prior to each hospital visit
• Group 1 (n=12) Smoke cigarettes regularly (smoked 20 of past 30 days, 5 or more cigarettes per day)
• Group 2 (n=12) use nicotine-containing e-cigarettes regularly (use on 20 of past 30 days)
• Participants may be dual users of cigarettes and e-cigarettes, but during the study will use their predominant product (i.e., the product they use on more days in the past 30 and more frequently on days that they use it).
• Saliva Cotinine \>50 ng/ml
• Age: ≥ 21 years old and ≤ 65 years old
• Willingness to abstain from smoking all combustible products (tobacco and cannabis) for 12 hours before admission
• Willingness to abstain from nicotine products (vaping/oral use) 12 hours before each admission

You may not qualify if:

• Unstable medical conditions:
• Heart disease
• Seizures
• Cancer
• Thyroid disease (okay if controlled with medication)
• Diabetes
• Hepatitis B or C or Liver disease
• Glaucoma
• Kidney disease or urinary retention
• An ulcer in the past year
• Diagnosis of asthma or COPD
• Drug/Alcohol Dependence
• Alcohol or illicit drug dependence within the past 12 months (currently in treatment) with the exception of those who recently completed an alcohol/drug treatment program
• Positive toxicology test at the screening visit (THC \& prescribed medications okay)
• Opioid replacement therapy (including methadone, buprenorphine, or other)

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94143, United States

Location

MeSH Terms

Interventions

Electronic Nicotine Delivery Systems

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Neal Benowitz, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Lawrence, BA

CONTACT

4155022465; lisa.lawrence@ucsf.edu

Armando Barraza, BA

CONTACT

4155022465; armando.barraza@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: The study protocol will be available on clinicaltrials.gov.

Locations

US (1)