Informing Oral Nicotine Pouch Regulations to Promote Public Health

Conditions

• Tobacco-Related Carcinoma

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample and oral mucosa sample collection
• Cigarette — DRUG
  Smoke usual brand cigarette
• Nicotine Oral Pouch — DRUG
  Insert low FBN R/S ONP
• Nicotine Oral Pouch — DRUG
  Insert low FBN \> 99% S ONP
• Nicotine Oral Pouch — DRUG
  Insert high R/S ONP
• Nicotine Oral Pouch — DRUG
  Insert high FBN \> 99% ONP
• Smokeless Tobacco — DRUG
  Insert ST
• Survey Administration — OTHER
  Ancillary studies
• Text Message-Based Navigation Intervention — OTHER
  Receive text with a link to daily diary surveys

Study Details

This clinical trial evaluates the characteristics of oral nicotine pouches (ONPs) to determine if they are a comparable substitute to cigarette or smokeless tobacco (ST) products. ONPs contain nicotine but no tobacco and are used primarily by adult tobacco uses in the United States (US). ONPs are recognized by the Food and Drug Administration as having lower risk than combustible cigarettes and are approved as a modified risk tobacco product. While ONPs have lower toxic risk than other tobacco products, acute and longer term harm related to their use has not been studied. Information gathered from this study may identify product characteristics of ONPs that improve successful switching from high-risk cigarettes or ST to lower risk ONPs.

Key Dates

Start date

Jan 13, 2025

Status verified

Apr 2026

Primary completion

Jan 31, 2028

Completion

Aug 31, 2028

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: PHASE I ARM I (low FBN R/S ONP)
  Participants insert low free-base nicotine (FBN) R/S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
• Experimental: PHASE I ARM II (low FBN > 99% S ONP)
  Participants insert low FBN \> 99% S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
• Experimental: PHASE I ARM III (high FBN R/S ONP)
  Participants insert high R/S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
• Experimental: PHASE I ARM IV (high FBN > 99% ONP)
  Participants insert high FBN \> 99% S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
• Experimental: PHASE I ARM V (Usual brand ST or cigarette)
  Participants insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes. Patients also undergo blood sample collection at 0, 5, 15, 30, 60, and 90 minutes.
• Experimental: PHASE II ARM I (low FBN R/S ONP)
  WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week. CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use. Participants insert low FBN R/S ONP for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
• Experimental: PHASE II ARM II (low FBN > 99% S ONP)
  WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week. CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use. Participants insert to low FBN \> 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
• Experimental: PHASE II ARM III (high R/S ONP)
  WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week. CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use. Participants insert to high R/S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
• Experimental: PHASE II ARM IV (high FBN > 99% ONP)
  WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week. CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use. Participants insert high FBN \> 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.

Primary Outcome Measure

Increased nicotine delivery [ Time Frame: Up to 3 months ]

Central Contacts

• The Ohio State University Comprehensive Cancer Center
  800-293-5066
  [email protected]

Locations (1)

Find similar trials in Columbus, OH

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