What side effects are associated with this type of intervention?

Health warnings as a behavioral modification strategy for hookah smoking primarily aim to increase awareness of health risks, potentially leading to reduced smoking behavior. This approach generally does not have direct physical side effects. However, it may cause psychological effects such as increased anxiety or stress about health risks. For other common smoking cessation treatments like pharmacotherapies (e.g., varenicline, nicotine replacement therapy), side effects can include nausea, rash, hiccups, mouth irritation, difficulty sleeping, and vivid dreams.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of hookah smoking. However, behavioral interventions, such as health warnings that increase awareness of the health risks associated with hookah smoking, have been studied as effective methods to reduce usage. These interventions aim to modify behavior by educating users about the dangers of hookah smoking, similar to strategies used in cigarette smoking cessation programs.

What other types of research exist?

Promising alternatives to health warnings for hookah smoking patients include: 1) Psychosocial interventions such as cognitive-behavioral therapy (CBT) and motivational enhancement therapy (MET); 2) Combined interventions using both CBT and MET; 3) Addiction counseling and mutual help groups like Marijuana Anonymous; 4) Personalized feedback interventions using real-time data from exhaled carbon monoxide testing; 5) Leveraging digital health tools and mobile apps for smoking cessation support.

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Health Warnings for Hookah Smoking

N/A

Recruiting

Led By Erin Sutfin, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at exit; up to 10 hours

Awards & highlights

Summary

This trial tests if health warnings in hookah cafés can reduce smoking. The study targets café customers and uses warnings to make them more aware of the risks, hoping they will smoke less.

Who is the study for?

This trial is for English-speaking individuals who plan to smoke hookah at a café and won't smoke cigarettes, cigars, or other tobacco products there. It's not open to those who've been asked to join this study elsewhere.

What is being tested?

The study is testing if health warnings at hookah cafés can make people smoke less compared to no warnings. This will be measured by the change in expired carbon monoxide levels before and after visiting the café.

What are the potential side effects?

Since this trial involves observing smoking behavior rather than a medical intervention, traditional side effects are not applicable. However, participants may experience discomfort from exposure to health warnings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at exit; up to 10 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at exit; up to 10 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and at exit; up to 10 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Expired Carbon Monoxide (eCO Boost)

Other study objectives

Behavioral intention

Beliefs

Hookah use behavior

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Intervention - Health WarningsExperimental Treatment1 Intervention

Cafes will display text-only warning signs

Group II: Control - No WarningsExperimental Treatment1 Intervention

No warnings posted in the hookah café

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for hookah smoking, particularly behavioral interventions like health warnings, work by increasing awareness of the health risks associated with smoking. These interventions present clear and impactful warnings that highlight the dangers, encouraging smokers to reduce or quit their use. This approach is crucial for hookah smoking patients as it targets the psychological and cognitive aspects of addiction, helping them make informed decisions about their health and potentially leading to reduced smoking behavior.

Systematic review of interventions aimed at reducing hookah pipe use: Implications for practitioners and clinicians.Nicotine Replacement Therapy: An Overview.

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,266 Previous Clinical Trials

1,012,147 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,001,440 Total Patients Enrolled

Erin Sutfin, PhDPrincipal InvestigatorWake Forest University Health Sciences

2 Previous Clinical Trials

2,722 Total Patients Enrolled

Media Library

Control - No Warnings Clinical Trial Eligibility Overview. Trial Name: NCT05916170 — N/A

Hookah Smoking Clinical Trial 2023: Control - No Warnings Highlights & Side Effects. Trial Name: NCT05916170 — N/A

Control - No Warnings 2023 Treatment Timeline for Medical Study. Trial Name: NCT05916170 — N/A

Hookah Smoking Research Study Groups: Control - No Warnings, Intervention - Health Warnings

~446 spots leftby Mar 2025

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