Effects of Nicotine Pouch Characteristics on Perceptions and Behavior

NCT06597435 | Recruiting

• 2 other identifiers: UP-23-01161K99DA058241
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

There is a growing sector of modern tobacco-free oral nicotine pouches that are federally regulated as non-medicinal nicotine/tobacco products. While nicotine pouches employ marketing approaches that may attract current tobacco users, such as marketing themes connoting minimal harm, information on the long-term health effects of nicotine pouches is lacking. nicotine pouches may appeal to younger adults because they are available in similar product characteristics (e.g., nicotine concentration, protonated nicotine) that many younger people prefer to use in e-cigarettes. In addition, nicotine pouches may be of particular interest to younger adult e-cigarette users because these products can be used discreetly where vaping is not allowed, which may translate into an increased likelihood of becoming dual users of e-cigarettes and nicotine pouches. Indeed, approximately 15% young adults who used e-cigarettes in the past 30 days were past 30-day nicotine pouch users. Manufacturers of modern nicotine pouches use acid additives to lower pH, which changes nicotine from a free-base to a protonated nicotine, resulting in improved appeal and sensory experience and higher abuse liability. Thus, nicotine concentration and pH in modern nicotine pouches should be focal targets for regulatory policies. Evidence is also lacking on mechanisms mediating differences in product appeal and abuse liability of nicotine pouches across products varying in nicotine concentration and pH level. The scientific objective of this research is to assess the effect of variation in nicotine concentration in nicotine pouches and its interaction effect with pH level on the proximal outcomes of relevance to the U.S. Food and Drug Administration regulation: sensory attributes and product appeal among younger adults who use nicotine pouches in the past 30 days (current dual users of nicotine pouches and e-cigarettes and/or combustible cigarettes will be eligible) and are unmotivated to quit nicotine use. This innovative project proposes to conduct a double-blind within-subject randomized study in which participants (N = 72) will administer nicotine pouches varied by nicotine concentration (e.g., 3 vs 6 mg) and pH (e.g., 8.5 or greater vs. less than 8.5) to achieve the project aim: to evaluate the effects of nicotine concentration and pH on subjective product appeal and sensory attributes of nicotine pouches. The findings of this proposed research will provide the U.S. Food and Drug Administration with new evidence necessary to inform regulatory restrictions on product characteristics and constituents of nicotine pouches, which may put young adults at risk of using a novel class of oral nicotine products.

Conditions

Nicotine Pouch Self-Administration

Outcome Measures

Primary Outcomes (1)

• Subjective Appeal and sensory experience

  Self-report measures of product appeal (e.g., liking, disliking, willingness to use again) and sensory attributes (e.g., sweetness, smoothness, bitterness, harshness) will be completed following the nicotine pouch administration.

  During the 3-hour experimental session, participant will self-administer 4 nicotine pouches, each with a 5-minute administration period. There will a 40-minute inter-product rest interval.

Study Arms (4)

Nicotine pouch containing high nicotine (6-8mg)

EXPERIMENTAL

Participants will self-administer a nicotine pouch containing 6-8mg nicotine.

Other: Nicotine pouch

Nicotine pouch containing low nicotine (3-4mg)

PLACEBO COMPARATOR

Participants will self-administer a nicotine pouch containing 3-4mg nicotine.

Other: Nicotine pouch

Nicotine pouch with low pH (less than 8.5)

EXPERIMENTAL

Participants will self-administer a nicotine pouch with low pH (less than 8.5).

Other: Nicotine pouch

Nicotine pouch with high pH (8.5 or greater)

PLACEBO COMPARATOR

Participants will self-administer a nicotine pouch with high pH (8.5 or greater).

Other: Nicotine pouch

Interventions

Nicotine pouch OTHER

Participants will self-administer an experimenter-provided nicotine pouch

Nicotine pouch containing high nicotine (6-8mg); Nicotine pouch containing low nicotine (3-4mg); Nicotine pouch with high pH (8.5 or greater); Nicotine pouch with low pH (less than 8.5)

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults age 21-35 years old.
• Current nicotine pouch users (used nicotine pouches in the past 30 days). Current dual users of nicotine pouches and e-cigarettes and/or combustible cigarettes will be eligible.
• Positive cotinine test via saliva test strip.
• Unmotivated to quit nicotine use.
• English language competency (read and speak English). The instruments used have not been translated and/or validated for other languages.

You may not qualify if:

• Intention to quit nicotine use in the next 30 days.
• Current pregnancy or breastfeeding (urine pregnancy test will be conducted during the orientation session).
• History of stroke, seizures, high blood pressure (hypertension), heart disease/problems, lung disease/lung problems, or cardiovascular disease contraindications for nicotine.
• People under 21 years will be excluded to correspond with the legal age for purchasing tobacco products in the United States. Special subject populations will not be recruited.

Sponsors & Collaborators

• University of Southern California: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of Southern California

Los Angeles, California, 90032, United States

NOT YET RECRUITING

University of Southern California - Clinical Sciences Building

Los Angeles, California, 90033, United States

RECRUITING

Study Officials

• Dae Hee Han, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dae Hee Han, PhD

CONTACT

626-200-8334; daeheeha@usc.edu

Adam Leventhal, PhD

CONTACT

adam.leventhal@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: October 31, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-09

Locations

US (2)