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Completed

NCT Number: NCT03096860

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Oklahoma Tobacco Research Center

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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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 -

Treatment and study plan

Active alcohol consumption

Other

Comparison of alcohol consumption vs. placebo consumption and hookah smoking.

Placebo consumption

Other

Comparison of alcohol consumption vs. placebo consumption and hookah smoking.

Primary outcomes

  1. Total volume smoke inhaled

    Time frame: up to 2 hours

    hookah topography

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Collaborators

  • University of Oklahoma

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 30, 2017
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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