Effect of Concurrent Hookah and Alcohol Consumption on Smoking Topography and Toxicant Exposure

Study Overview
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Brief Summary
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The purpose of the current study is to investigate in a prospective randomized cross-over trial, the impact of alcohol versus a placebo drink on smoking behavior and topography (duration and frequency of puffing), abuse liability, and toxicity. It is hypothesized that drinking alcohol before smoking will be associated with longer puffs and shorter duration between puffs and greater abuse liability and toxicity.

Official Title
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Effect of Concurrent Hookah and Alcohol Consumption on Smoking Topography and Toxicant Exposure

Conditions
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Hookah Smoking, Alcohol Use, Unspecified

Intervention / Treatment
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* Other: Active alcohol consumption
* Other: Placebo consumption


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Report using hookah at least 1 time per month over the past 6 months Are at least 21 years old Speak and understand English Do not currently suffer from lung disease including asthma, CF, or COPD Do not currently suffer from heart disease Are not currently pregnant or breast-feeding or have plans to become pregnant or begin breast-feeding at any point during the study No current, regular use of >5 cigarettes or other tobacco products (e.g., e-cig, cigar, etc.) per month. No current marijuana use > 5 times per month No use of illicit drugs during the past 30 days willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours and abstain from alcohol for at least 24 hours prior to each of the two sessions Live within 25 miles of the study location. Have a friend who is eligible and willing to participate. Consume 2 or more or one or more drinks per episode for men and women, respectively Drink alcohol at least one time per week Not currently be seeking treatment for alcohol use Able to answer at least two hookah-specific screening questions from the screener. - Exclusion Criteria: Hookah use less than one time per month over the past 6 months Under the age of 21 Unwilling to abstain from alcohol for 24 hours and tobacco and nicotine products 12 hours prior to each study visit Live more than 25 miles from the study location Pregnant or breast feeding or plan to become pregnant or begin breast feeding at any point in the study -

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcohol consumption and hookah<br> | Other: Active alcohol consumption<br>* Comparison of alcohol consumption vs. placebo consumption and hookah smoking.<br>|
| Placebo Comparator: Placebo consumption and hookah<br> | Other: Placebo consumption<br>* Comparison of alcohol consumption vs. placebo consumption and hookah smoking.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total volume smoke inhaled | hookah topography | up to 2 hours |