Imaging Glutamate Release From Alcohol

NCT ID: NCT04159688

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-06-30

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.

Conditions

Alcohol Drinking

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Alcohol Challenge

Alcohol Challenge, oral, targeting BAL of 60 mg/dL, Given once

Group Type: EXPERIMENTAL

Alcohol

Intervention Type: DRUG

Alcohol Challenge

Interventions

Alcohol

Alcohol Challenge

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ansel T Hillmer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K01AA024788-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000026672

Identifier Type: -

Identifier Source: org_study_id