Recruiting

Alcohol & Stress

Sponsor:

Yale University

Code:

NCT06584448

Conditions

Alcohol Use Disorder

Alcohol Use, Unspecified

Heavy Drinker

Alcohol Use Disorder, Moderate, in Sustained Remission

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Deuterium Metabolic Imaging with deuterated acetate tracer

Study Details

Brief summary:

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.

Conditions

Alcohol Use Disorder

Alcohol Use, Unspecified

Heavy Drinker

Alcohol Use Disorder, Moderate, in Sustained Remission

Study ID

NCT06584448

Start date

Nov 6, 2024

Status verified date

Aug, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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)

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: 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)

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.

Interventions

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.

Primary outcome measure

  • Rate of Conversion of Acetate to Glutamate + Glutamine (Glx) in the Brain [ Time Frame: Baseline and for TS, once within approximately one week and again at approximately one month ]
  • Concentration of [2H]Glx in the brain during administration of [2H]acetate [ Time Frame: Baseline and for treatment seekers, once after 1 month sober. ]

Central Contacts and Locations

Central contacts

Graeme Mason, Ph.D.

203-737-1478graeme.mason@yale.edu

Luz Catarineau

475-375-6141luz.catarineau@yale.edu

Locations

The Anlyan Center, 300 Cedar St.

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Elizabeth Guidone, BA

475-375-6141Elizabeth.Guidone@yale.edu

Principal Investigator:

Graeme Mason, Ph.D

More Information

Sponsor

Yale University

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Brain
  • Stress
  • Imaging
  • Detoxification
  • Recovery
  • Sobriety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-08-12.