Alcohol Use, UnspecifiedNCT03096860
Effect of Concurrent Hookah and Alcohol Consumption on Smoking Topography and Toxicant Exposure
A study testing Active alcohol consumption in people with Alcohol Use, Unspecified and Hookah Smoking, run by Oklahoma State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Unspecified, Hookah Smoking
- What is being tested?
- Active alcohol consumption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2017to 10 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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.
- -
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
United States1 site
The Oklahoma Tobacco Research Center
Oklahoma City, Oklahoma, 73104
About this study
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.
- Conditions
- Alcohol Use, Unspecified, Hookah Smoking
- Being tested
- Active alcohol consumption, Placebo consumption
- Medical subject headings
- Alcohol Drinking, Water Pipe Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active alcohol consumptionOther
Comparison of alcohol consumption vs. placebo consumption and hookah smoking.
Placebo consumptionOther
Comparison of alcohol consumption vs. placebo consumption and hookah smoking.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol consumption and hookah | Experimental | Not described Receives: Other: Active alcohol consumption |
| Placebo consumption and hookah | Placebo comparator | Not described Receives: Other: Placebo consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume smoke inhaled
hookah topography
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start22 Feb 2017
- Primary completion10 Oct 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma
- Responsible party
- Principal investigator, Eleanor Leavens, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096860
- Sponsor's protocol ID
- NIH/NIDA F31 DA04252
- Status last verified
- Oct 2017
- First submitted
- 20 Mar 2017
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30820567
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Concurrent Hookah and Alcohol Consumption on Smoking Topography and Toxicant Exposure
- ClinicalTrials.gov ID
- NCT03096860
- Acronym / sponsor ID
- NIH/NIDA F31 DA04252
- Conditions
- Alcohol Use, Unspecified, Hookah Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Collaborators
- University of Oklahoma
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol consumption and hookah | Experimental | Other: Active alcohol consumption |
| Placebo consumption and hookah | Placebo comparator | Other: Placebo consumption |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (5 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active alcohol consumptionComparison of alcohol consumption vs. placebo consumption and hookah smoking. | Other | Alcohol consumption and hookah |
| Placebo consumptionComparison of alcohol consumption vs. placebo consumption and hookah smoking. | Other | Placebo consumption and hookah |
Primary outcome
Total volume smoke inhaled
Time frame: up to 2 hours
hookah topography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Derived from this study: PubMed 30820567Leavens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active alcohol consumption in people with Alcohol Use, Unspecified and Hookah Smoking, run by Oklahoma State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total volume smoke inhaled (time frame: up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03096860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.