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

Primary Purpose

Alcohol Use, Unspecified, Hookah Smoking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active alcohol consumption
Placebo consumption
Sponsored by
Oklahoma State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Use, Unspecified

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 -

Sites / Locations

  • The Oklahoma Tobacco Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alcohol consumption and hookah

Placebo consumption and hookah

Arm Description

Outcomes

Primary Outcome Measures

Total volume smoke inhaled
hookah topography

Secondary Outcome Measures

Full Information

First Posted
March 20, 2017
Last Updated
October 11, 2017
Sponsor
Oklahoma State University
Collaborators
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT03096860
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
October 10, 2017 (Actual)
Study Completion Date
October 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oklahoma State University
Collaborators
University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use, Unspecified, Hookah Smoking

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcohol consumption and hookah
Arm Type
Experimental
Arm Title
Placebo consumption and hookah
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Active alcohol consumption
Intervention Description
Comparison of alcohol consumption vs. placebo consumption and hookah smoking.
Intervention Type
Other
Intervention Name(s)
Placebo consumption
Intervention Description
Comparison of alcohol consumption vs. placebo consumption and hookah smoking.
Primary Outcome Measure Information:
Title
Total volume smoke inhaled
Description
hookah topography
Time Frame
up to 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 -
Facility Information:
Facility Name
The Oklahoma Tobacco Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30820567
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.
Results Reference
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Effect of Concurrent Hookah and Alcohol Consumption on Smoking Topography and Toxicant Exposure

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