Measuring the Neuroimmune Response to Alcohol

• Status: Enrolling by invitation
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study uses positron emission tomography imaging of the 18-kDa translocator protein to measure the brain's immune response to alcohol.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Treatments: Ethanol

Criteria

Inclusion criteria:

• Men and women, aged 21-30 years, medically healthy upon physical examination and laboratory testing

• Recent experience (last 90 days) consuming at least 4 (women) or 5 (men) standard drinks in a single occasion. This ensures that customary drinking levels are not exceeded during the study.

• Able to read and write English; willing and able to provide voluntary, written informed consent

Exclusion criteria:

• Current significant medical conditions, such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology, including COPD and anemia

• Past or current neurological disorder or disorders affecting the brain, including but not limited to multiple sclerosis, history of stroke, brain tumors, traumatic brain injury with loss of consciousness, seizures

• Past or current psychiatric disorder (DSM-5 diagnosis, assessed by SCID-5), including substance use disorder, and past or current psychotic symptoms

• Participants whose previous alcohol experience does not exceed the targeted alcohol dose (4 standard drinks for women, 5 standard drinks for men, all during the same occasion), for ethical purposes.

• 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 use or regular use in the past 6 months of any prescription, psychoactive, or herbal medications (e.g., antidepressants, antipsychotics, anxiolytics, ecstasy, marijuana), with no current drug use confirmed by urine toxicology. No participant will be asked to stop taking medication to participate in the study

• Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or her partner is surgically sterile: hormone contraceptives (oral, implant, injection, patch, or ring), contraceptive sponge, double barrier (diaphragm or condom plus spermicide), or IUD

• Contraindications to MRI, such as claustrophobia or metal in their body

• Participants whose participation would cause them to exceed yearly radiation limits for research subjects

• Participants will be excluded for any infection or vaccination in the previous month or regular use of nonsteroidal anti-inflammatory drugs (to avoid these factors from influencing the TSPO signal)

• Individuals who are classified as "low binders" for the rs6971 polymorphism (<10% of the population). This genetic polymorphism has a well-characterized effect on [11C]PBR28 affinity for TSPO141. Homozygotes for the minor allele have negligible specific binding, and are therefore excluded.