Clinical trial · Interventional
Drinking, Acetate, and Stress
Role of Acetate in Heavy Drinking
NCT06584448CI-TRIAL-00121683recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alcohol Use Disorder | — | UNRESOLVED | — |
| Alcohol Use Disorder, Moderate, in Sustained Remission | — | UNRESOLVED | — |
| Alcohol Use, Unspecified | — | UNRESOLVED | — |
| Heavy Drinker | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Deuterium Metabolic Imaging with deuterated acetate tracer | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Light/Non Drinking (LD)
- description
- 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.
- interventionNames
- Other: Deuterium Metabolic Imaging with deuterated acetate tracer
- type
- EXPERIMENTAL
- label
- Heavy/Non-Dependent Risky Drinking (HD)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.