Alcohol DrinkingEarly Phase 1NCT04251221
Measuring the Neuroimmune Response to Alcohol
A Early Phase 1 study testing Oral Alcohol Challenge in people with Alcohol Drinking, run by Yale University at 1 site in United States.
Trial summary
This study uses positron emission tomography imaging of the 18-kDa translocator protein to measure the brain's immune response to alcohol. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Oral Alcohol Challenge
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2019to 20 Nov 2021
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
General Inclusion Criteria:
- Men and women, aged 21-50 years
- Willing and able to give voluntary written informed consent
- Able to read and write English and communicate effectively with the investigators, and comply with all study requirements, restrictions, and directions of the clinic staff
- AUD Subjects will meet DSM-5 criteria for current Alcohol Use Disorder
- Moderate Drinkers will report consuming alcohol on at least one occasion in the past three months that would result in an estimated blood alcohol level greater than 100 mg/dl but not meet DSM-5 criteria for AUD. This is to ensure that subjects have prior drinking exposure consistent with levels proposed in this study. Prospective subjects will be asked to recall the heaviest two days of drinking in the previous three months. Using this information, approximate BAC will be calculated for those prior episodes.
- Medically healthy upon physical examination and laboratory testing.
General Exclusion Criteria:
- Individuals whom the investigators deem may not be able to comply with alcohol abstinence for 48 hours prior to study day.
- Current significant medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology.
- History of or current neurological or significant psychiatric disorder such as schizophrenia or bipolar disorder (DSM-5 Axis 1).
- Other substance use disorder with the exception of nicotine dependence in smokers as assessed with the SCID or positive urine screen for drugs of abuse.
- Participants with any significant current medical conditions that would contraindicate the consumption of alcohol, such as history of neurological trauma or diseases, seizures, delirium or hallucinations, hepatic, or other unstable medical conditions.
- Current suicidal or homicidal intent or behavior, or history of suicidal or homicidal behavior.
- No barbiturates or other known microsomal enzyme induces or inhibitors in the past month.
- History of significant head trauma.
- Women who are pregnant or nursing or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives [oral, implant, injection, patch, or ring], contraceptive sponge, double barrier [diaphragm or condom plus spermicide], or IUD).
- Regular or current significant use of any prescription, herbal or illegal psychotropic medications (e.g., antidepressants, antipsychotics, anxiolytics, ecstasy) in the past 6 mo, with no current illegal drug use confirmed by urine toxicology (except for cocaine and marijuana when relevant).
- Have MRI-incompatible implants and other contraindications for MRI, such as a pacemaker, artificial joints, non-removable body piercings, claustrophobia, etc.
- Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year.
- Subjects with current, past or anticipated exposure to radiation in the work place within one year of proposed research PET scans.
- Subjects with history of IV drug use which would prevent venous access for PET tracer injection.
- Blood donation within eight weeks of the start of the study
- History of blooding disorder or currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).
Trial locations and contacts
1 site in 1 country.
About this study
This study uses positron emission tomography imaging of the 18-kDa translocator protein to measure the brain's immune response to alcohol.
Read the detailed description
Alcohol Use Disorder affects nearly 14% of the population, accruing considerable cost to individual families and society. Much of this cost stems from alcohol's influence on the immune system. Alcohol impairs peripheral immune function, evidenced by increased susceptibility to infection related diseases such as liver cirrhosis and pancreatitis. The neuroimmune consequences of alcohol are subtler. Preclinically, alcohol triggers neuroimmune abnormalities that contribute to cognitive dysfunction, neurodegeneration, and alter alcohol drinking behaviors. Yet, limited experimental tools hamper translational efforts to study alcohol's effects on neuroimmune function in people. We propose to address this deficit by developing an innovative human imaging paradigm that measures neuroimmune response to alcohol.
- Conditions
- Alcohol Drinking
- Being tested
- Oral Alcohol Challenge
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Alcohol ChallengeDrug
Subjects will drink an alcohol dose designed to achieve a BAL of 0.08
| Study group | Role | What they receive |
|---|---|---|
| Moderate Drinkers | Experimental | Aim 1:
A baseline PET scan with [11C]PBR28, a TSPO-specific radioligand, will be conducted with moderate drinkers. Next, subjects will drink a fixed alcohol dose, followed a post-alcohol [11C]PBR28 PET scan timed to capture acute neuroimmune response. [11C]PBR28 distribution volumes (VT), which are proportional to TSPO number, will be measured throughout the brain. We will test the hypothesis that acute alcohol robustly increases [11C]PBR28 VT, consistent with microglial activation. The percent change in [11C]PBR28 VT (ΔVT) from baseline will quantify the magnitude of neuroimmune response. Receives: Drug: Oral Alcohol Challenge |
| Alcohol Use Disorder (AUD) | Experimental | Aim 2:
AUD subjects will participate in the study design described in Aim 1 (a baseline [11C]PBR28 PET scan, drink a fixed alcohol dose, followed by a post-alcohol [11C]PBR28 PET scans). The magnitude of neuroimmune response, quantified by ΔVT, will be compared between moderate drinkers and individuals with AUD to test the hypothesis that the neuroimmune response to alcohol is greater in those with AUD compared to moderate drinkers, consistent with the concept of alcohol 'priming microglia'. Receives: Drug: Oral Alcohol Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in [11C]PBR28 Distribution Volume After Alcohol Challenge.
This is the percent change in [11C]PBR28 distribution volume (V_T) post-alcohol relative to baseline.
This is calculated as [V_T(Post-Alcohol) - V_T(Baseline)]/V_T(Baseline)
As a percent change, it could range from -10% to 200%.
Measured: The post-alcohol imaging scan start will begin between one and fours hours after the oral alcohol challenge is completed. The total scan time for each imaging scan is 120 minutes long.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start20 Jun 2019
- Primary completion20 Nov 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Ansel Hillmer, Yale University
- Investigators
- Ansel T Hillmer, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251221
- Sponsor's protocol ID
- 2000024444
- Other IDs
- 1U54AA027989-01
- Status last verified
- Oct 2023
- First submitted
- 30 Jan 2020
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Neuroimmune Response to Alcohol
- ClinicalTrials.gov ID
- NCT04251221
- Acronym / sponsor ID
- 2000024444
- Conditions
- Alcohol Drinking
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study uses positron emission tomography imaging of the 18-kDa translocator protein to measure the brain's immune response to alcohol.
Detailed description
Alcohol Use Disorder affects nearly 14% of the population, accruing considerable cost to individual families and society. Much of this cost stems from alcohol's influence on the immune system. Alcohol impairs peripheral immune function, evidenced by increased susceptibility to infection related diseases such as liver cirrhosis and pancreatitis. The neuroimmune consequences of alcohol are subtler. Preclinically, alcohol triggers neuroimmune abnormalities that contribute to cognitive dysfunction, neurodegeneration, and alter alcohol drinking behaviors. Yet, limited experimental tools hamper translational efforts to study alcohol's effects on neuroimmune function in people. We propose to address this deficit by developing an innovative human imaging paradigm that measures neuroimmune response to alcohol.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Drinkers | Experimental | Drug: Oral Alcohol ChallengeAim 1: A baseline PET scan with [11C]PBR28, a TSPO-specific radioligand, will be conducted with moderate drinkers. Next, subjects will drink a fixed alcohol dose, followed a post-alcohol [11C]PBR28 PET scan timed to capture acute neuroimmune response. [11C]PBR28 distribution volumes (VT), which are proportional to TSPO number, will be measured throughout the brain. We will test the hypothesis that acute alcohol robustly increases [11C]PBR28 VT, consistent with microglial activation. The percent change in [11C]PBR28 VT (ΔVT) from baseline will quantify the magnitude of neuroimmune response. |
| Alcohol Use Disorder (AUD) | Experimental | Drug: Oral Alcohol ChallengeAim 2: AUD subjects will participate in the study design described in Aim 1 (a baseline [11C]PBR28 PET scan, drink a fixed alcohol dose, followed by a post-alcohol [11C]PBR28 PET scans). The magnitude of neuroimmune response, quantified by ΔVT, will be compared between moderate drinkers and individuals with AUD to test the hypothesis that the neuroimmune response to alcohol is greater in those with AUD compared to moderate drinkers, consistent with the concept of alcohol 'priming microglia'. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Oral Alcohol ChallengeSubjects will drink an alcohol dose designed to achieve a BAL of 0.08 | Drug | Alcohol Use Disorder (AUD), Moderate Drinkers |
Primary outcome
Percent Change in [11C]PBR28 Distribution Volume After Alcohol Challenge.
Time frame: The post-alcohol imaging scan start will begin between one and fours hours after the oral alcohol challenge is completed. The total scan time for each imaging scan is 120 minutes long.
This is the percent change in [11C]PBR28 distribution volume (V_T) post-alcohol relative to baseline. This is calculated as [V_T(Post-Alcohol) - V_T(Baseline)]/V_T(Baseline) As a percent change, it could range from -10% to 200%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ansel T Hillmer, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oral Alcohol Challenge in people with Alcohol Drinking, run by Yale 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?
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 7 Nov 2023. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in [11C]PBR28 Distribution Volume After Alcohol Challenge. (time frame: The post-alcohol imaging scan start will begin between one and fours hours after the oral alcohol challenge is completed. The total scan time for each imaging scan is 120 minutes long.). 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 7 Nov 2023.