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New treatment option for Alcohol Use Disorder
Official title Imaging CRF X NOP Interactions in Alcohol Use Disorder
ClinicalTrials.gov ID: NCT07612631
What this study is testing
What is Hydrocortisone?
Hydrocortisone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for alcohol use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This positron emission tomography imaging study uses [C-11]NOP-1A and hydrocortisone to image stress-modulating proteins in heavy drinking alcohol use disorder (AUD) subjects and healthy controls (HC). It will also characterize the role of these stress-regulating proteins in a relapse to alcohol.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Heavy drinking alcohol use disorder people (AUD)
- Males or females between 18 and 55 years old
- fulfill DSM-5 criteria for moderate or severe ( \> or = 4 criteria) alcohol use disorder
- 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...
- No lifetime DSM-5 psychiatric disorders, including schizophrenia, schizoaffective disorder, bipolar disorder, or developmental disorders.
See the full eligibility criteria
- Heavy drinking alcohol use disorder people (AUD)
- Males or females between 18 and 55 years old
- fulfill DSM-5 criteria for moderate or severe ( \> or = 4 criteria) alcohol use disorder
- 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...
- No lifetime DSM-5 psychiatric disorders, including schizophrenia, schizoaffective disorder, bipolar disorder, or developmental disorders.
- No comorbid current DSM-5 depressive or anxiety disorders
- No other current DSM-5 substance use disorders, including opioids, cocaine, amphetamines, sedative-hypnotics, hallucinogens, and inhalants. people with current moderate and severe DSM-5 cannabis use disorder will also...
- 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...
- 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...
- 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...
- No history of anemia or history of deep vein thrombosis, pulmonary embolism, thrombocytopenia or thrombocytosis
- Not currently pregnant or breast-feeding
- 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
- 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...
- No metallic objects in the body that are contraindicated for MRI. Healthy Control people (HC)
- Males or females between 18 and 55 years old
- No DSM-5 psychiatric or substance use disorders other than tobacco use disorder
- 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)
- 7 to 14 above.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.