Hookah Additive Research to Inform Product Standards

Summary

This clinical trial evaluates how the content of waterpipe (WP) tobacco affects the appeal, puffing behavior, and toxicity of WP tobacco smoking. The data from the proposed study will provide direct links between WP tobacco's primary additives (sugars and humectants), CO and nicotine biomarkers, smoker preferences, perceptions of harm and puffing behaviors, and the subsequent range of toxicant exposures associated with these additives and behaviors. Study outcomes include waterpipe puffing behaviors, exhaled carbon monoxide levels, nicotine uptake, spirometry, sensory perceptions, smoking appeal, and risk perception. Waterpipe tobacco smoking is often the first combustible tobacco product tried by adolescents and young adults, possibly due to the widespread availability of heavily sweetened waterpipe tobacco and the perception that waterpipe smoking is a safer alternative to cigarette smoking. However, waterpipe tobacco smoking is associated with lung disease, carbon monoxide poisoning, and precursor conditions for oral and other cancers in adolescents and young adults. There is currently little data available on how the primary additives (by weight) in waterpipe tobacco affect puffing behaviors, toxicant exposures, pulmonary function and appeal. This clinical trial uses established waterpipe tobacco smokers, four investigational tobacco products with precisely manipulated levels of humectants and natural sugars in a single-blind, crossover (repeated measures) study design to determine how waterpipe tobacco additives effect human puffing behavior, nicotine uptake, flavor perceptions, lung function, and biomarkers of exposure.

Conditions

• Tobacco-Related Carcinoma

Interventions

OTHER

Questionnaire Administration

Ancillary studies

BEHAVIORAL

Tobacco Smoking

Smoke waterpipe tobacco

Sponsors & Collaborators

• Ohio State University

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Food and Drug Administration (FDA)

  collaborator FED

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Marielle C Brinkman · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

21 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-06-19

Primary Completion

2023-05-11

Completion

2023-05-11

Countries

• United States

Study Locations