Drinking, Acetate, and Stress

Study Purpose

The purpose of this study is to learn how drinking alcohol affects how people experience stress and how that is affected by the body's chemistry. Specifically, the investigators will be studying relationships of drinking and a stress hormone called cortisol. The investigators believe that results will lead us to find more effective ways to help people stop or reduce drinking when participants are drinking at harmful levels.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 55 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Provision of signed and dated informed consent form.

- Stated willingness to comply with all study procedures and availability for the duration of the study.

- Medically stable male or female, aged 18-55.

- Able to read, write and complete a multitude of self-assessments in English.

- Meets DSM-5 criteria for current Alcohol Use Disorder (AUD) - Participants who have Alcohol Use Disorder and are actively drinking must be willing to receive (at no cost) inpatient treatment for AUD for a period of up to 30 days.

Participants who have been treated for an Alcohol Use Disorder and are now sober three months or longer will NOT be required to go inpatient.

Exclusion Criteria:

- Subjects with any significant current medical conditions (neurological, cardiovascular, endocrine, thyroid, renal, liver), seizures (for LTS subjects only- seizures directly related to alcohol detoxification are not an exclusion) , delirium or hallucinations, or other unstable medical conditions, including HIV.

- Current DSM-5 substance use disorder (other than AUD or tobacco use disorder) - Any metallic objects implanted in their body which would make imaging unsafe (pacemaker, etc) - Claustrophobia, or other inability to participate in an MRI.

- A positive test result at intake appointment and subsequent appointments on urine drug screens conducted for illicit drugs.

(Note: participants will not be paid for study visits if they test positive for an illicit drug and will be immediately excluded from study).

- Women who are pregnant or nursing.

Women who have an IUD that would make imaging unsafe.

- Recent taking of medications that may influence study outcomes (e.g., disulfiram, naltrexone, acamprosate, anticonvulsants).

- Subjects likely to exhibit clinically significant alcohol withdrawal during the study.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06584448
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Yale University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Graeme Mason, Ph.D.
Principal Investigator Affiliation	Yale University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Alcohol Use Disorder, Alcohol Use, Unspecified, Heavy Drinker, Alcohol Use Disorder, Moderate, in Sustained Remission

Additional Details

Brain acetate consumption will be measured with a novel method called Deuterium Metabolic Imaging (DMI), in which sodium acetate that has been labeled with deuterium, a non-radioactive isotope of hydrogen, is administered intravenously over two hours, while Magnetic Resonance Spectroscopy (MRS) is used to map the appearance of the deuterium in glutamate and glutamine regionally through the brain. That combination of glutamate and glutamine, called Glx, serves as a tag to measure the brain's rate of acetate consumption. That is, the more deuterium appears in Glx, the more acetate that part of the brain consumes. In the same people, investigators will perform structural Magnetic Resonance Imaging (MRI) for co-registration with the MRI and assess regional brain volumes. Investigators will also obtain measures of drinking and stress, and will measure participants serum cortisol levels and rates of cortisol turnover. Each set of measures will be compared across groups, and the measurements of acetate uptake will be compared with all other measures for associations.

Arms & Interventions

Arms

Experimental: Light/Non Drinking (LD)

Participants will complete an initial telephone screen. Participants found to be potentially eligible will be scheduled for an in-person Intake Session (consisting of an interview, questionnaires, lab work, and a urine drug screen). Participants found to be eligible will be scheduled for an infusion study. Participants will undergo brain imaging with intravenous administration of deuterated sodium acetate. Deuterium is a naturally occurring, non-radioactive substance that allows us to measure rates of metabolism. Neurocognitive tests will be performed to assess the impact of alcohol drinking.

Experimental: Heavy/Non-Dependent Risky Drinking (HD)

Experimental: Treatment Seeking (TS)

Participants will complete an initial telephone screen. Participants to be potentially eligible will be scheduled for an in-person Intake Session (consisting of an interview, questionnaires, lab work, and a urine drug screen). If found to be eligible participants will be scheduled for an inpatient admission. Participants will take part in an inpatient, medically supervised detoxification. In early sobriety (normally within one week of the last drink) and after approximately one month, participants will undergo brain imaging with intravenous administration of deuterated sodium acetate. Deuterium is a naturally occurring, non-radioactive substance that allows us to measure rates of metabolism. Neurocognitive tests will be performed to assess the impact of alcohol drinking.

Experimental: Long-Term Recovery (LTS)

Interventions

Other: - Deuterium Metabolic Imaging with deuterated acetate tracer

Deuterium Metabolic Imaging (DMI) is a method by which Magnetic Resonance Spectroscopy (MRS) is used to map the appearance of deuterium from a tracer source (e.g., deuterated acetate) in products of metabolism. In this case we will map the combination of glutamate and glutamine, called Glx, to serve as a tag to measure the brain's rate of acetate consumption. That is, the more deuterium appears in Glx, the more acetate that part of the brain consumes.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

The Anlyan Center, 300 Cedar St., New Haven 4839366, Connecticut 4831725

Status

Recruiting

Address

The Anlyan Center, 300 Cedar St.

New Haven 4839366, Connecticut 4831725, 06519

Site Contact

Elizabeth Guidone, BA

[email protected]

475-375-6141

Yale University, New Haven 4839366, Connecticut 4831725

Status

Not yet recruiting

Address

Yale University

New Haven 4839366, Connecticut 4831725, 06520

Site Contact

Graeme Mason, Ph.D.

[email protected]

203-737-1478

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