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

Not Applicable

Completed

• Conditions: Hookah Smoking; Alcohol Use, Unspecified
• Interventions: Other: Active alcohol consumption; Other: Placebo consumption

• Registration Number: NCT03096860
• Lead Sponsor: Oklahoma State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-22
• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-24
• Study First Posted: 2017-03-30
• Status Verified: 2017-10
• Primary Completion: 2017-10-10
• Study Completion: 2017-10-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Alcohol consumption and hookah	Active alcohol consumption	-
Placebo consumption and hookah	Placebo consumption	-

Primary Outcome Measures

Name	Time	Method
Total volume smoke inhaled	up to 2 hours	hookah topography

Trial Locations

Locations (1)

The Oklahoma Tobacco Research Center; 🇺🇸 Oklahoma City, Oklahoma, United States