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Imaging Glutamate Release From Alcohol

Primary Purpose

Alcohol Drinking

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Alcohol
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Drinking

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Yale UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alcohol Challenge

Arm Description

Alcohol Challenge, I.V. infusion, 60 mg/dL in 6% saline (v/v), Given once

Outcomes

Primary Outcome Measures

Alcohol-induced change in receptor availability
The percent change in receptor availability will be measured from the PET data

Secondary Outcome Measures

Full Information

First Posted
November 6, 2019
Last Updated
February 23, 2023
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04159688
Brief Title
Imaging Glutamate Release From Alcohol
Official Title
Imaging Glutamate Release From Alcohol
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alcohol Challenge
Arm Type
Experimental
Arm Description
Alcohol Challenge, I.V. infusion, 60 mg/dL in 6% saline (v/v), Given once
Intervention Type
Drug
Intervention Name(s)
Alcohol
Intervention Description
Alcohol Challenge
Primary Outcome Measure Information:
Title
Alcohol-induced change in receptor availability
Description
The percent change in receptor availability will be measured from the PET data
Time Frame
Baseline and within 2 hours of challenge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women, aged 21-55 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 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. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ansel T Hillmer, Ph.D.
Phone
2037376400
Email
ansel.hillmer@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jon M Anderson, M.S.
Phone
2037376400
Email
jonmikael.anderson@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ansel T Hillmer, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon M Anderson
Phone
203-737-6400
Email
jonmikael.anderson@yale.edu
First Name & Middle Initial & Last Name & Degree
Ansel T Hillmer, Ph.D.
Phone
2037376400
Email
ansel.hillmer@yale.edu
First Name & Middle Initial & Last Name & Degree
Ansel T Hillmer, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Imaging Glutamate Release From Alcohol

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