Alcohol DrinkingNCT03483389
Alcohol and Immune Response
A study testing Alcohol, Ethyl in people with Alcohol Drinking and Alcohol; Harmful Use, run by Brown University at 1 site in United States.
Trial summary
This study investigates how alcohol affects the immune system and behavior in healthy adults. The study also will examine how an individual's typical drinking habits may affect the immune system's response to alcohol. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol; Harmful Use
- What is being tested?
- Alcohol, Ethyl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 18 Jun 2021
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 21-55 years
- Able to speak and read English
- Regular use of alcohol
- Weight > or = to 110 lbs and body mass index (BMI) in the 18.5-30 kg/m2 range
- No self-reported use of drugs
Who cannot join
- Currently seeking treatment for alcohol or drug use
- Chronic disease
- Use of certain medications
- GI disorders
- Daily/near-daily use of NSAIDs
- Positive urine test for certain drugs
Show all 14Show fewer
- History of withdrawal symptoms precipitated by alcohol abstinence
- Clinical Institute Withdrawal Assessment for Alcohol score greater than or equal to 10
- History of seizures
- Current major psychiatric disorder
- History of adverse reaction to standard blood draw
- Inability to abstain from tobacco for 8 hours
- Inability to abstain from cannabis for 48 hours
- Pregnant, breastfeeding, or may become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune Activation and Neurodegeneration in HIV Infection and Heavy Drinking
This study investigates how alcohol affects the immune system and behavior in healthy adults. The study also will examine how an individual's typical drinking habits may affect the immune system's response to alcohol.
- Conditions
- Alcohol Drinking, Alcohol; Harmful Use
- Being tested
- Alcohol, Ethyl, Alcohol, Ethyl - placebo
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol, EthylDrug
Also called Alcohol
Randomized within-subjects design
Alcohol, Ethyl - placeboOther
Also called Placebo
Randomized within-subjects design
| Study group | Role | What they receive |
|---|---|---|
| Alcohol, placebo | Experimental | Alcohol, ethyl - Placebo Receives: Drug: Alcohol, Ethyl; Other: Alcohol, Ethyl - placebo |
| Alcohol, low dose | Experimental | Alcohol, ethyl - Low dose Receives: Drug: Alcohol, Ethyl; Other: Alcohol, Ethyl - placebo |
| Alcohol, moderate dose | Experimental | Alcohol, ethyl - Moderate dose Receives: Drug: Alcohol, Ethyl; Other: Alcohol, Ethyl - placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma lipopolysaccharide (pg/ml)
Plasma concentration of lipopolysaccharide, measured in picograms/ml
Measured: 0-4 hours
Plasma lipopolysaccharide binding protein (ng/ml)
Plasma concentration of lipopolysaccharide binding protein, measured in nanograms/ml
Measured: 0-4 hours
Soluble cluster of differentiation 14 (ng/ml)
Plasma concentration of soluble cluster of differentiation 14, measured in nanograms/ml
Measured: 0-4 hours
Soluble cluster of differentiation 163 (ng/ml)
Plasma concentration of soluble cluster of differentiation 163, measured in nanograms/ml
Measured: 0-4 hours
Secondary outcomes (1)
Response time in ms
Response time in milliseconds, as measured by the NIH Toolbox and Cued Go/No-Go test
Measured: 0-4 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 2018
- Study start1 Oct 2018
- Primary completion18 Jun 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mollie Monnig, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483389
- Sponsor's protocol ID
- 1710001919
- Status last verified
- Jul 2021
- First submitted
- 6 Mar 2018
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Activation and Neurodegeneration in HIV Infection and Heavy Drinking
- ClinicalTrials.gov ID
- NCT03483389
- Acronym / sponsor ID
- 1710001919
- Conditions
- Alcohol Drinking, Alcohol; Harmful Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 30 Mar 2018 (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.
This study investigates how alcohol affects the immune system and behavior in healthy adults. The study also will examine how an individual's typical drinking habits may affect the immune system's response to alcohol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alcohol, placebo | Experimental | Drug: Alcohol, Ethyl, Other: Alcohol, Ethyl - placeboAlcohol, ethyl - Placebo |
| Alcohol, low dose | Experimental | Drug: Alcohol, Ethyl, Other: Alcohol, Ethyl - placeboAlcohol, ethyl - Low dose |
| Alcohol, moderate dose | Experimental | Drug: Alcohol, Ethyl, Other: Alcohol, Ethyl - placeboAlcohol, ethyl - Moderate dose |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ages 21-55 years
- Able to speak and read English
- Regular use of alcohol
- Weight > or = to 110 lbs and body mass index (BMI) in the 18.5-30 kg/m2 range
- No self-reported use of drugs
Key exclusion criteria (14 listed)
- Currently seeking treatment for alcohol or drug use
- Chronic disease
- Use of certain medications
- GI disorders
- Daily/near-daily use of NSAIDs
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 |
|---|---|---|
| Alcohol, EthylAlso: AlcoholRandomized within-subjects design | Drug | Alcohol, low dose, Alcohol, moderate dose, Alcohol, placebo |
| Alcohol, Ethyl - placeboAlso: PlaceboRandomized within-subjects design | Other | Alcohol, low dose, Alcohol, moderate dose, Alcohol, placebo |
Primary outcome
Plasma lipopolysaccharide (pg/ml)
Time frame: 0-4 hours
Plasma concentration of lipopolysaccharide, measured in picograms/ml
Plasma lipopolysaccharide binding protein (ng/ml)
Time frame: 0-4 hours
Plasma concentration of lipopolysaccharide binding protein, measured in nanograms/ml
Soluble cluster of differentiation 14 (ng/ml)
Time frame: 0-4 hours
Plasma concentration of soluble cluster of differentiation 14, measured in nanograms/ml
Soluble cluster of differentiation 163 (ng/ml)
Time frame: 0-4 hours
Plasma concentration of soluble cluster of differentiation 163, measured in nanograms/ml
1 secondary outcome
Response time in ms
Time frame: 0-4 hours
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 27 Jul 2021.
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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 Alcohol, Ethyl in people with Alcohol Drinking and Alcohol; Harmful Use, run by Brown 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 5 inclusion and 14 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 27 Jul 2021. 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. 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?
Plasma lipopolysaccharide (pg/ml) (time frame: 0-4 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2021.