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Measuring the Neuroimmune Response to Alcohol

Sponsor
Yale University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04251221
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
91
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Oral Alcohol Challenge
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Measuring the Neuroimmune Response to Alcohol
Actual Study Start Date :
Jun 1, 2019
Actual Primary Completion Date :
Jun 20, 2019
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Social Drinkers

Subjects will drink an alcohol dose designed to achieve a BAL of 0.08.

Drug: Oral Alcohol Challenge
Subjects will drink an alcohol dose designed to achieve a BAL of 0.08

Outcome Measures

Primary Outcome Measures

  1. Neuroimmune Response to Alcohol [Measured 1-4 hours after oral alcohol challenge ends - Will require ~120 minutes]

    This is the percent change in [11C]PBR28 distribution volume post-alcohol relative to baseline. As a percent change, it could range from -10% to 200%.

  2. Subjective Response to Alcohol - Stimulating [60 min after alcohol challenge]

    The Biphasic Alcohol Effects Scale - Stimulating Subscale

  3. Subjective Response to Alcohol - Sedative [150 min after alcohol challenge]

    The Biphasic Alcohol Effects Scale - Stimulating Subscale

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale University New Haven Connecticut United States 06511

Sponsors and Collaborators

  • Yale University

Investigators

  • Principal Investigator: Ansel T Hillmer, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ansel Hillmer, Assistant Professor of Radiology and Biomedical Imaging and of Psychiatry, Yale University
ClinicalTrials.gov Identifier:
NCT04251221
Other Study ID Numbers:
  • 2000024444
First Posted:
Jan 31, 2020
Last Update Posted:
Dec 17, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Alcohol Drinking

Study Results

No Results Posted as of Dec 17, 2021