Recruiting

Oral Nicotine Pouch

Sponsor:

University of Southern California

Code:

NCT07698470

Conditions

Nicotine Dependence

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

Interventions

Oral Nicotine Pouch

Smoking Cue Reactivity Task

Study Details

Brief summary:

Oral nicotine pouches (ONPs) are non-combustible nicotine products that may reduce cigarette craving and smoking cue-induced brain activity, supporting their potential as harm-reduction tools for adults who smoke cigarettes. This within-subject, repeated-measures study will evaluate the acute effects of a single 6 mg oral nicotine pouch on subjective craving and prefrontal neural responses to smoking-related cues using functional near-infrared spectroscopy (fNIRS). Participants will complete assessments before and after nicotine pouch administration following overnight nicotine abstinence to characterize changes in craving and neural cue reactivity.

Conditions

Nicotine Dependence

Study ID

NCT07698470

Start date

Apr 30, 2026

Status verified date

Jul, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 21 years - 55 years
  • Self-reported use of cigarettes within the past 30 days
  • Biochemical confirmation of cigarette use:

o Carbon monoxide (CO) breath sample ≥10 ppm
  • Fagerström Test for Nicotine Dependence (FTND) score ≥5, indicating moderate to high nicotine dependence
  • Fluent in English
  • Willing to try an oral nicotine pouch
  • Willing to abstain from nicotine for at least 12 hours prior to each experimental session

Exclusion Criteria:

  • Age younger than 21 years or older than 55 years
  • Biochemical evidence inconsistent with recent cigarette use:

o CO breath sample <10 ppm
  • Expressed intent to reduce or quit nicotine use within the next 30 days
  • History of medical conditions contraindicated for nicotine use (e.g., uncontrolled hypertension, recent cardiac events)
  • Primary use of non-cigarette products (e.g., cigars, pipe tobacco, smokeless tobacco)
  • Prior use of oral nicotine products in their lifetime

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Acute Oral Nicotine Pouch Administration

Adult cigarette smokers will complete one experimental session consisting of pre-pouch cue reactivity and subjective assessments, administration of a single 6 mg oral nicotine pouch, a standardized 25-minute absorption period, and identical post-pouch assessments. All participants complete the same study procedures and serve as their own control for pre- versus post-intervention comparisons.

Interventions

Oral Nicotine Pouch

Participants will self-administer one commercially available 6 mg oral nicotine pouch following overnight nicotine abstinence. The pouch will be used for approximately 25 minutes before participants complete the post-pouch cue reactivity assessment.

Smoking Cue Reactivity Task

Participants will complete a standardized smoking cue reactivity task before and after oral nicotine pouch administration. During each task, participants will view smoking-related and neutral images, complete guided imagination trials while holding either a cigarette or a neutral object, and undergo simultaneous functional near-infrared spectroscopy (fNIRS) to measure prefrontal brain activity.

Primary outcome measure

  • Change in Prefrontal Neural Cue Reactivity to Smoking-Related Cues Measured by Functional Near-Infrared Spectroscopy (fNIRS) [ Time Frame: Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session. ]
  • Change in Subjective Cigarette Craving Measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief) [ Time Frame: Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session. ]

Central Contacts and Locations

Central contacts

USC Nicotine and Tobacco Studies

213-821-0807USCONPStudy@gmail.com

Locations

University of Southern California - 3641 Watt Way (HNB B22)

Recruiting

Los Angeles, California, United States, 90089

Contacts

USC Nicotine and Tobacco Studies

213-821-0807USCONPStudy@gmail.com

More Information

Sponsor

University of Southern California

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Oral Nicotine Pouches
  • Oral Nicotine Products
  • Smoking
  • Cigarettes
  • Harm Reduction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-07-13.