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

Alcohol Use, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03096860
• Other study ID #: NIH/NIDA F31 DA04252
• Status: Completed
• Phase: N/A
• First received: March 20, 2017
• Last updated: October 11, 2017
• Start date: February 22, 2017
• Est. completion date: October 10, 2017

Study information

• Verified date: October 2017
• Source: Oklahoma State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 10, 2017
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use, Unspecified
• Hookah Smoking

Intervention

Other:
• Active alcohol consumption
Comparison of alcohol consumption vs. placebo consumption and hookah smoking.
• Placebo consumption
Comparison of alcohol consumption vs. placebo consumption and hookah smoking.

Locations

Country	Name	City	State
United States	The Oklahoma Tobacco Research Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Oklahoma State University	University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total volume smoke inhaled	hookah topography	up to 2 hours