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.

Study Overview

• Status: Completed
• Conditions: Alcohol Use, Unspecified; Hookah Smoking
• Intervention / Treatment: Other: Active alcohol consumption; Other: Placebo consumption

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • The Oklahoma Tobacco Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

    -

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 -

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alcohol consumption and hookah	Other: Active alcohol consumption; Comparison of alcohol consumption vs. placebo consumption and hookah smoking.
Placebo Comparator: Placebo consumption and hookah	Other: Placebo consumption; Comparison of alcohol consumption vs. placebo consumption and hookah smoking.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oklahoma State University
• Collaborators: University of Oklahoma

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2017
• Primary Completion (Actual): October 10, 2017
• Study Completion (Actual): October 10, 2017

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 30, 2017

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: NIH/NIDA F31 DA04252

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No