Imaging Glutamate Release From Alcohol

The goal of this research project is to determine the sensitivity of PET radioligands specific for targets in the glutamate system to an alcohol challenge.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Drinking
• Intervention / Treatment: Drug: Alcohol

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Ansel T Hillmer, Ph.D.; Phone Number: 2037376400; Email: ansel.hillmer@yale.edu
• Study Contact Backup: Name: Marla Genova, M.S.; Phone Number: 2037376400; Email: marla.genova@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Recruiting
      • Yale University
      • Contact: Ansel T Hillmer, Ph.D.; Phone Number: 2037376400; Email: ansel.hillmer@yale.edu
      • Principal Investigator: Ansel T Hillmer, Ph.D.
      • Contact: Marla Genova; Phone Number: 203-737-6400; Email: marla.genova@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Men and women, aged 21-55 years
2. Willing and able to give voluntary written informed consent
3. 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
4. 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.
5. Medically healthy upon physical examination and laboratory testing.

Exclusion Criteria:

1. Individuals whom the investigators deem may not be able to comply with alcohol abstinence for 48 hours prior to study day.
2. Current significant medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology.
3. History of or current neurological or significant psychiatric disorder such as schizophrenia or bipolar disorder (DSM-5 Axis 1).
4. 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.
5. 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.
6. Current suicidal or homicidal intent or behavior, or history of suicidal or homicidal behavior.
7. No barbiturates or other known microsomal enzyme induces or inhibitors in the past month.
8. History of significant head trauma.
9. 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).
10. 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).
11. Have MRI-incompatible implants and other contraindications for MRI, such as a pacemaker, artificial joints, non-removable body piercings, claustrophobia, etc.
12. 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.
13. Subjects with current, past or anticipated exposure to radiation in the work place within one year of proposed research PET scans.
14. Subjects with history of IV drug use which would prevent venous access for PET tracer injection.
15. Blood donation within eight weeks of the start of the study
16. History of blooding disorder or currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alcohol Challenge; Alcohol Challenge, I.V. infusion, 60 mg/dL in 6% saline (v/v), Given once	Drug: Alcohol; Alcohol Challenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol-induced change in receptor availability	The percent change in receptor availability will be measured from the PET data	Baseline and within 2 hours of challenge

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Ansel T Hillmer, Ph.D., Yale University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 2000026672; 1K01AA024788-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No