Drinking, Acetate, and Stress
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Yale University
- Study ID
- NCT06584448
- Status
- Recruiting
Conditions
- Alcohol Use Disorder
- Alcohol Use Disorder, Moderate, in Sustained Remission
- Alcohol Use, Unspecified
- Heavy Drinker
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- Deuterium Metabolic Imaging with deuterated acetate tracer — OTHERDeuterium 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.
Study Details
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.
Key Dates
- Start date
- Nov 6, 2024
- Status verified
- Jul 2025
- Primary completion
- Jan 31, 2029
- Completion
- Jan 31, 2030
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
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.
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 ]
Central Contacts
- Graeme Mason, Ph.D.203-737-1478
- Elizabeth Guidone, B.A.475-375-6141
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Anlyan Center, 300 Cedar St. | New Haven | Connecticut | 06519 | Graeme Mason, Ph.D (PRINCIPAL_INVESTIGATOR) |
| Yale University | New Haven | Connecticut | 06520 |
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