Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05236894

Appeal of Nicotine Pouches Versus Cigarettes in the Ohio Appalachia Population

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:
Examining the Appeal of Nicotine Pouches in Ohio Appalachia

Clinical Trial Summary

This clinical trial estimates the abuse liability of nicotine pouches with varying nicotine concentrations relative to cigarette smoking in Appalachian, Ohio and Ohio smokers. Nicotine pouches are a novel tobacco product with potential to reduce or increase the harm of tobacco use. Evaluating nicotine pouches abuse liability among smokers in Ohio including the unique demographic of Appalachia may clarify the public health effect of NPs in Appalachian Ohio and across Ohio. Results may inform public health efforts, policy, and clinical care aimed at reducing tobacco-related disparities.

Clinical Trial Description

Aim 1: PRIMARY OBJECTIVE: I. To estimate the abuse liability of nicotine pouches (NPs) with varying nicotine concentrations relative to cigarette smoking. SECONDARY OBJECTIVE: I. To clarify the public health effect of NPs in Appalachian Ohio. EXPLORATORY OBJECTIVES: I. To estimate the abuse liability of NPs with varying nicotine concentrations relative to cigarette smoking by measuring nicotine pharmacokinetics. II. To estimate the abuse liability of NPs with varying nicotine concentrations relative to cigarette smoking by measuring subjective effects. III. To estimate the abuse liability of NPs with varying nicotine concentrations relative to cigarette smoking by measuring intentions to use and switch to NPs. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients receive lower dose nicotine pouch orally (PO) over 30 minutes at visits 1, 2, and 3. ARM II: Patients receive higher dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3. ARM III: Patients smoke usual brand of cigarettes, taking one puff every 30 seconds over 5 minutes at visits 1, 2, and 3. Aim 2: PRIMARY OBJECTIVE: I. To understand the pharmacokinetic difference between tobacco-derived and synthetic NPs. SECONDARY OBJECTIVE: I. To clarify the public health effect of NPs on adult smokers EXPLORATORY OBJECTIVES: I. To understand the differences in abuse liability between tobacco-derived and synthetic NPs by measuring nicotine pharmacokinetics. II. To understand the differences in abuse liability between tobacco-derived and synthetic NPs by measuring subjective effects. III. To estimate the abuse liability of tobacco-derived vs. synthetic NPs by measuring intentions to use and switch to NPs. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients receive a 3mg dose nicotine pouch orally (PO) over 30 minutes at visits 1, 2, and 3. ARM II: Patients receive a 3mg dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3. ARM III: Patients receive a 3mg dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3. ;

Study Design

Related Conditions & MeSH terms

  • Cigarette Smoking-Related Carcinoma
Clinical Trial Details
NCT number NCT05236894
Study type Interventional
Source Ohio State University Comprehensive Cancer Center
Contact
Status Active, not recruiting
Phase Early Phase 1
Start date March 1, 2022
Completion date December 31, 2025
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06038526 - Evaluation of Canakinumab in High-Risk Former-Smokers Phase 2
Recruiting NCT05121051 - Testing the Effect of the Broccoli Seed and Sprout Extract, Avmacol ES, on the Cancer Causing Substances of Tobacco in Heavy Smokers Phase 2
Not yet recruiting NCT06386432 - EQQUAL-NM for the Promotion of Smoking Cessation in Sexual and Gender Minority Young Adults in New Mexico N/A
Active, not recruiting NCT02964182 - Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and Intermittent Cigarette Smokers N/A
Completed NCT04510077 - SmartQuit Program for Smoking Cessation N/A
Recruiting NCT06230159 - Evaluating the Impact of Synthetic Cooling Agents in Combustible Cigarettes on Smoking Perceptions and Use N/A
Completed NCT04525222 - mHealth Mood Management Tool (Actify) to Improve Population-Level Smoking Cessation Phase 1
Recruiting NCT05825001 - Evaluating the Episodic Future Thinking Intervention for Reducing Cigarette Consumption in Cigarette Smokers N/A
Completed NCT05455086 - Free-Base Nicotine or Nicotine Salt e-Liquids in Current E-Cigarette Smokers, PeloPET Study N/A
Recruiting NCT06010355 - Culturally Tailored Educational Video to Promote Lung Cancer Screening in Vulnerable Communities N/A
Not yet recruiting NCT06213532 - CONNECTing to LungCare N/A
Recruiting NCT03856515 - Gender Differences in Switching From Smoking Regular Cigarettes to E-Cigarettes N/A
Completed NCT03480373 - Electronic Cigarette Use During Pregnancy
Not yet recruiting NCT06055231 - PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis Phase 1
Not yet recruiting NCT06145763 - A Digital Smoking Cessation Intervention for Helping American Indians and Alaska Natives Quit Smoking N/A
Active, not recruiting NCT04308759 - An Innovative Conversational Agent (Quitbot) for Smoking Cessation Phase 3
Active, not recruiting NCT04972513 - Impact of E-cigarette Use on the Body
Withdrawn NCT05024955 - Evaluating Shared Decision-Making for Lung Cancer Screening Among Chinese Populations in the United States
Completed NCT05227027 - Pilot Trial of a Game Embedded in a Smartphone App for Smoking Cessation N/A
Completed NCT04502524 - Website Smoking Cessation Intervention for the Promotion of Smoking Cessation in Low-Income Veterans Phase 1