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

Oklahoma State University

Status: Completed

Conditions: Alcohol Use, Unspecified; Hookah Smoking

Treatments: Other: Active alcohol consumption; Other: Placebo consumption

Study type: Interventional

Funder types: Other

Identifiers

NCT03096860

NIH/NIDA F31 DA04252

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts 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 -

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Alcohol consumption and hookah

Experimental group

Treatment:

Other: Active alcohol consumption

Placebo consumption and hookah

Placebo Comparator group

Treatment:

Other: Placebo consumption