Your session is about to expire
← Back to Search
Other
Nicotine Pouches for Nicotine Addiction
N/A
Recruiting
Led By Dae Hee Han, PhD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults age 21-35 years old
Be between 18 and 65 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Summary
"This trial aims to study the effects of different nicotine concentrations and pH levels in modern tobacco-free oral nicotine pouches on the appeal and sensory attributes among younger adults who use these products. The research will provide
Who is the study for?
This trial is for young adults who have used nicotine pouches and e-cigarettes or combustible cigarettes in the past 30 days. Participants should not be looking to quit nicotine use. The study specifically targets current dual users of these products.
What is being tested?
The study is testing how different levels of nicotine concentration (3 mg vs 6 mg) and pH values (8.5 or higher vs lower than 8.5) in nicotine pouches affect their appeal and sensory experience among users, using a double-blind randomized design.
What are the potential side effects?
While specific side effects are not detailed here, typical risks may include throat irritation, increased heart rate, nausea, addiction potential, and other symptoms associated with nicotine use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 35 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of stroke, seizures, high blood pressure, heart or lung problems.
Select...
I am 21 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Subjective Appeal and sensory experience
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Nicotine pouch with low pH (less than 8.5)Experimental Treatment1 Intervention
Participants will self-administer a nicotine pouch with low pH (less than 8.5).
Group II: Nicotine pouch containing high nicotine (6-8mg)Experimental Treatment1 Intervention
Participants will self-administer a nicotine pouch containing 6-8mg nicotine.
Group III: Nicotine pouch with high pH (8.5 or greater)Placebo Group1 Intervention
Participants will self-administer a nicotine pouch with high pH (8.5 or greater).
Group IV: Nicotine pouch containing low nicotine (3-4mg)Placebo Group1 Intervention
Participants will self-administer a nicotine pouch containing 3-4mg nicotine.
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,329,863 Total Patients Enrolled
18 Trials studying Nicotine Addiction
2,476 Patients Enrolled for Nicotine Addiction
University of Southern CaliforniaLead Sponsor
946 Previous Clinical Trials
1,604,547 Total Patients Enrolled
Dae Hee Han, PhDPrincipal InvestigatorUniversity of Southern California