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

NCT ID: NCT03096860

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-22

Study Completion Date

2017-10-10

Brief Summary

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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

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Conditions

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Alcohol Use, Unspecified Hookah Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Alcohol consumption and hookah

Group Type EXPERIMENTAL

Active alcohol consumption

Intervention Type OTHER

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

Placebo consumption and hookah

Group Type PLACEBO_COMPARATOR

Placebo consumption

Intervention Type OTHER

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

Interventions

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Active alcohol consumption

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

Intervention Type OTHER

Placebo consumption

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

Intervention Type OTHER

Eligibility Criteria

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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 -
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oklahoma

OTHER

Sponsor Role collaborator

Oklahoma State University

OTHER

Sponsor Role lead

Responsible Party

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Eleanor Leavens

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Oklahoma Tobacco Research Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30820567 (View on PubMed)

Other Identifiers

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NIH/NIDA F31 DA04252

Identifier Type: -

Identifier Source: org_study_id