Effects of alcohol on stress and brain chemistry
Role of Acetate in Heavy Drinking
NA · Yale University · NCT06584448
This study is testing how drinking alcohol affects stress and brain chemistry in people to find better ways to help reduce harmful drinking habits.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Yale University (other) |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT06584448 on ClinicalTrials.gov |
What this trial studies
This study investigates how alcohol consumption influences stress responses and the body's chemistry, particularly focusing on the hormone cortisol. Using a novel technique called Deuterium Metabolic Imaging (DMI), researchers will measure brain acetate consumption while participants undergo Magnetic Resonance Spectroscopy (MRS) to assess brain chemistry. Participants will also have their drinking behaviors, stress levels, and cortisol measurements evaluated to understand the relationships between these factors. The goal is to identify more effective strategies for reducing harmful drinking behaviors.
Who should consider this trial
Good fit: Ideal candidates are medically stable adults aged 18-55 who meet the criteria for current Alcohol Use Disorder and are willing to participate in inpatient treatment if actively drinking.
Not a fit: Patients with significant medical conditions or other substance use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for individuals struggling with alcohol use disorder.
How similar studies have performed: Other studies have explored the relationship between alcohol and stress, but this specific approach using DMI is relatively novel.
Eligibility criteria
Show full 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.
Where this trial is running
New Haven, Connecticut and 1 other locations
- The Anlyan Center, 300 Cedar St. — New Haven, Connecticut, United States (RECRUITING)
- Yale University — New Haven, Connecticut, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Graeme Mason, Ph.D. — Yale University
- Study coordinator: Graeme Mason, Ph.D.
- Email: graeme.mason@yale.edu
- Phone: 203-737-1478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alcohol Use Disorder, Alcohol Use, Unspecified, Heavy Drinker, Alcohol Use Disorder, Moderate, in Sustained Remission, Brain, Stress, Imaging, Detoxification