NCT03096860

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2017

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2017

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

March 20, 2017

Last Update Submit

October 11, 2017

Conditions

Alcohol Use, UnspecifiedHookah Smoking

Outcome Measures

Primary Outcomes (1)

  • Total volume smoke inhaled

    hookah topography

    up to 2 hours

Study Arms (2)

Alcohol consumption and hookah

EXPERIMENTAL
Other: Active alcohol consumption

Placebo consumption and hookah

PLACEBO COMPARATOR
Other: Placebo consumption

Interventions

Active alcohol consumptionOTHER

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

Alcohol consumption and hookah
Placebo consumptionOTHER

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

Placebo consumption and hookah

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Oklahoma Tobacco Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

  • 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.

    PMID: 30820567DERIVED

MeSH Terms

Conditions

Alcohol DrinkingWater Pipe Smoking

Interventions

ExerciseEthanolEconomics

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorPipe SmokingSmoking

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaAlcoholsOrganic ChemicalsHealth Care Economics and Organizations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 30, 2017

Study Start

February 22, 2017

Primary Completion

October 10, 2017

Study Completion

October 10, 2017

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

US(1)