Imaging brain stress systems in people with heavy drinking to see if cortisol boosts NOP signals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase imaging study uses [C-11]NOP-1A PET scans to measure how stress hormones affect NOP receptor signaling in the brain. Participants include heavy-drinking adults with alcohol use disorder and healthy controls. They will have a baseline PET scan, receive hydrocortisone, and then have a post-hydrocortisone PET to compare changes in binding, focusing on the amygdala and related reward regions. The goal is to determine if cortisol-induced NOP receptor activity is heightened in AUD and whether it predicts relapse risk. The findings could illuminate a neurochemical pathway involved in stress-related relapse.

Why it matters

Who can join: the full rules

Heavy drinking alcohol use disorder subjects (AUD)

1. Males or females between 18 and 55 years old
2. fulfill DSM-5 criteria for moderate or severe ( \> or = 4 criteria) alcohol use disorder
3. fulfill both NIAAA heavy drinking91 (consuming for males \> or = 5 drinks on any day; for females \> or = 4 drinks on any day) and WHO high-risk/very high-risk drinking level criteria66 (for males \> or = 30 drinks/week; for females \> or = 20 drinks/week) in the past four weeks prior to enrollment
4. No lifetime DSM-5 psychiatric disorders, including schizophrenia, schizoaffective disorder, bipolar disorder, or developmental disorders.
5. No comorbid current DSM-5 depressive or anxiety disorders
6. No other current DSM-5 substance use disorders, including opioids, cocaine, amphetamines, sedative-hypnotics, hallucinogens, and inhalants. Subjects with current moderate and severe DSM-5 cannabis use disorder will also be excluded
7. Not currently on psychotropic medications that can directly (e.g., buprenorphine) or indirectly influence binding to NOP (e.g., medications that alter dopamine, GABA, glutamate, etc.) or modify alcohol consumption patterns (e.g., naltrexone, acamprosate, disulfiram);
8. No regular use of medical medications that can potentially interact with hydrocortisone (other corticosteroids, mifepristone, etc.) or increase the risks associated with arterial line removal (warfarin, clopidogrel, aspirin, naproxen, ibuprofen, etc.)
9. No clinically significant medical or neurological illnesses, including a history of immune compromise, HPA-axis dysfunction, Cushing's syndrome, glaucoma, morbid obesity, severe hyperglycemia, and hyperlipidemia, all of which are contraindications for hydrocortisone
10. No history of anemia or history of deep vein thrombosis, pulmonary embolism, thrombocytopenia or thrombocytosis
11. Not currently pregnant or breast-feeding
12. No history of complicated alcohol withdrawal symptoms such as seizures, alcoholic hallucinosis, delirium tremens, or required admission to an inpatient detox program to prevent such symptoms
13. Not currently employed as a radiation worker or has participated in a radiation-related research protocol within the previous year such that the total cumulative annual radiation dose (i.e., from participation in previous radioactive drug studies and this study) would exceed the radiation dose limits specified in the FDA regulations (i.e., 21 CFR 361.1) that govern the research use of radiotracers
14. No metallic objects in the body that are contraindicated for MRI.

Healthy Control subjects (HC)

1. Males or females between 18 and 55 years old
2. No DSM-5 psychiatric or substance use disorders other than tobacco use disorder
3. No NIAAA heavy drinking in the past year (\> or = 5 drinks on any day or more than 14 drinks per week for males; \> or = 4 drinks on any day or more than 7 drinks per week for females)
4. 7 to 14 above.

Where it's running

• University of Pittsburgh
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Rajesh Narendran — University of Pittsburgh
• Study coordinator: Rajesh Narendran
• Email: narendranr@upmc.edu
• Phone: 412-647-5176

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.