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Behavioral Intervention

Hookah Additives for Tobacco-Related Cancer (HARPS Trial)

N/A
Waitlist Available
Led By Marielle C Brinkman
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

HARPS Trial Summary

This trial will test how different levels of sugar and humectants in waterpipe tobacco affects smokers' behavior, nicotine uptake, and perceptions of the tobacco.

HARPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Exhaled breath carbon monoxide (CO)
Change in FEV1/FVC; The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs.
Change in Forced expiratory flow at 25-75% of FVC
+13 more

HARPS Trial Design

4Treatment groups
Experimental Treatment
Group I: Tobacco flavor preparation; Medium Sweetness, Medium Humectant (tobacco smoking)Experimental Treatment2 Interventions
Participants smoke 1 of 4 waterpipe tobacco preparations over 45-60 minutes over 4 sessions, separated by at least 1 week. Questionnaires administered.
Group II: Tobacco flavor preparation; Medium Sweetness, High Humectant (tobacco smoking)Experimental Treatment2 Interventions
Participants smoke 1 of 4 waterpipe tobacco preparations over 45-60 minutes over 4 sessions, separated by at least 1 week. Questionnaires administered.
Group III: Tobacco flavor preparation; High Sweetness, Medium Humectant (tobacco smoking)Experimental Treatment2 Interventions
Participants smoke 1 of 4 waterpipe tobacco preparations over 45-60 minutes over 4 sessions, separated by at least 1 week. Questionnaires administered.
Group IV: Tobacco flavor preparation; High Sweetness, High Humectant (tobacco smoking)Experimental Treatment2 Interventions
Participants smoke 1 of 4 waterpipe tobacco preparations over 45-60 minutes over 4 sessions, separated by at least 1 week. Questionnaires administered.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tobacco Smoking
2022
N/A
~1360

Find a Location

Who is running the clinical trial?

Ohio State UniversityOTHER
828 Previous Clinical Trials
505,697 Total Patients Enrolled
Food and Drug Administration (FDA)FED
171 Previous Clinical Trials
1,331,552 Total Patients Enrolled
Food and Drug Administration Center for Tobacco ProductsUNKNOWN

Media Library

Waterpipe Additive Research (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05453773 — N/A
Tobacco-Related Cancer Research Study Groups: Tobacco flavor preparation; Medium Sweetness, Medium Humectant (tobacco smoking), Tobacco flavor preparation; Medium Sweetness, High Humectant (tobacco smoking), Tobacco flavor preparation; High Sweetness, High Humectant (tobacco smoking), Tobacco flavor preparation; High Sweetness, Medium Humectant (tobacco smoking)
Tobacco-Related Cancer Clinical Trial 2023: Waterpipe Additive Research Highlights & Side Effects. Trial Name: NCT05453773 — N/A
Waterpipe Additive Research (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05453773 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are in the current clinical trial?

"Affirmative. Clinicaltrials.gov's records prove that this trial, initially posted on 19th June 2022 and recently updated 6th July 2022, is actively enrolling individuals. The requisite amount of participants needed are 56; recruited from a solitary location."

Answered by AI

Does this medical trial accept participants over the age of 20?

"Patients from the age of majority to 50 can be accepted into this study."

Answered by AI

Is enrollment currently available to participants for this experiment?

"Affirmative. Clinical trials data on clinicaltrials.gov verifies that this trial, which was first advertised in June 19th 2022, is currently recruiting participants. The specific number of sought-after patients stands at 56 and the enrolment will take place exclusively at one medical facility."

Answered by AI

Is there the possibility to participate in this experiment?

"This clinical trial seeks 56 individuals aged between 21 and 50 who have been diagnosed with tobacco-related carcinoma. Additional criteria that must be fulfilled include: Comprehension of the consent form and study details, No nicotine product use in the 12 hours prior to laboratory visits, Participation in four 3 hour long lab sessions at a consistent time each day, Fluency in English language."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Tennessee
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
Ohio State University Comprehensive Cancer Center

Why did patients apply to this trial?

Money and to stop smoking.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Hookah Additive Research to Inform Product Standards
Marielle Brinkman 2022. "Hookah Additive Research to Inform Product Standards". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05453773.
~19 spots leftby Apr 2025
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