Clinical trial NCT03096860: Effect of Concurrent Hookah and Alcohol Consumption on Smoking Topography and Toxicant Exposure
Official title: Effect of Concurrent Hookah and Alcohol Consumption on Smoking Topography and Toxicant Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use, Unspecified
Hookah Smoking
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
Collaborators: name: University of Oklahoma
First posted: 2017-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Report using hookah at least 1 time per month over the past 6 months
2. Are at least 21 years old
3. Speak and understand English
4. Do not currently suffer from lung disease including asthma, CF, or COPD
5. Do not currently suffer from heart disease
6. Are not currently pregnant or breast-feeding or have plans to become pregnant or begin breast-feeding at any point during the study
7. No current, regular use of \>5 cigarettes or other tobacco products (e.g., e-cig, cigar, etc.) per month.
8. No current marijuana use \> 5 times per month
9. No use of illicit drugs during the past 30 days
10. 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
11. Live within 25 miles of the study location.
12. Have a friend who is eligible and willing to participate.
13. Consume 2 or more or one or more drinks per episode for men and women, respectively
14. Drink alcohol at least one time per week
15. Not currently be seeking treatment for alcohol use
16. Able to answer at least two hookah-specific screening questions from the screener.

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Exclusion Criteria:

1. Hookah use less than one time per month over the past 6 months
2. Under the age of 21
3. Unwilling to abstain from alcohol for 24 hours and tobacco and nicotine products 12 hours prior to each study visit
4. Live more than 25 miles from the study location
5. Pregnant or breast feeding or plan to become pregnant or begin breast feeding at any point in the study -

Primary outcomes:
measure: Total volume smoke inhaled
timeFrame: up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: The Oklahoma Tobacco Research Center
state: Oklahoma
Study officials:
References:
citation: Leavens ELS, Morgan TL, Brett EI, Patzkowsky K, Son J, Molina N, Eissenberg T, Shihadeh A, Leffingwell TR, Wagener TL. Concurrent Alcohol Use and Waterpipe Tobacco Smoking: Smoking Topography, Toxicant Exposure, and Abuse Liability. Nicotine Tob Res. 2020 Feb 6;22(2):280-287. doi: 10.1093/ntr/ntz032.