Clinical trial NCT04159688: Imaging Glutamate Release From Alcohol
Official title: Imaging Glutamate Release From Alcohol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alcohol Drinking
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-11-12
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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).

Primary outcomes:
measure: Alcohol-induced Change in Receptor Availability
timeFrame: Baseline and within 2 hours of challenge
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Ansel T Hillmer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: