- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07612631
Imaging CRF X NOP Interactions in Alcohol Use Disorder
1. juni 2026 opdateret af: Rajesh Narendran
Does a Hyperactive Nociceptin Opioid Peptide Receptor System Promote Relapse in Heavy Drinking AUD Subjects: a [C-11]NOP-1A and Hydrocortisone PET Study
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.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
Hydrocortisone administration leads to a 10 to 15% increase in [11C]NOP-1A VT in brain regions, including the amygdala.
Increased NOP measured in response to cortisol, and by extension, corticotrophin-releasing factor (CRF), in this paradigm reflects an individual's ability to enhance N/OFQ transmission during stress.
Here, the investigators propose to use this novel imaging paradigm to compare hydrocortisone-induced increases in [11C]NOP-1A binding (DVT) in the amygdala (and secondary reward regions) in heavy drinking AUD subjects Vs.
HC.
The hypothesis that hydrocortisone-induced increases in [11C]NOP-1A binding (DVT) will be larger in heavy drinking AUD relative to HC (aim 1), and this will predict relapse to alcohol (aim 2).
Such a result will support the presence of a hyperactive NOP receptor system in response to increases in cortisol/CRF during conditions such as stress, chronic pain, etc., promoting relapse in heavy drinking AUD subjects.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
90
Fase
- Tidlig fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Rajesh Narendran
- Telefonnummer: 412-647-5176
- E-mail: narendranr@upmc.edu
Studiesteder
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Rekruttering
- University of Pittsburgh
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Heavy drinking alcohol use disorder subjects (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 drinks/week; for females > or = 20 drinks/week) in the past four weeks prior to enrollment
- 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. Subjects with current moderate and severe DSM-5 cannabis use disorder will also be excluded
- 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);
- 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.)
- 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
- 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 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
- No metallic objects in the body that are contraindicated for MRI.
Healthy Control subjects (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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: KÆLEDYR
[C-11]NOP-1A
|
Radiotracer
Intravenous, 1 mg/Kg
Radiotracer
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Amygdala DELTA VT
Tidsramme: Baseline/pre hydrocortisone, and 3-hours post hydrocortisone
|
VT is the volume of distribution expressed relative to total plasma radioligand concentration; DELTA VT is the change from baseline to post-hydrocortisone
|
Baseline/pre hydrocortisone, and 3-hours post hydrocortisone
|
|
Total number of negative ETG tests
Tidsramme: over 8-week follow-up
|
Represents level of abstinence in contingency management
|
over 8-week follow-up
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Midbrain DELTA VT
Tidsramme: Baseline/pre hydrocortisone and 3-hours post hydrocortisone
|
VT is the volume of distribution expressed relative to total plasma radioligand
|
Baseline/pre hydrocortisone and 3-hours post hydrocortisone
|
|
Ventral striatum DELTA VT
Tidsramme: Baseline/pre hydrocortisone and 3-hours post hydrocortisone
|
VT is the volume of distribution expressed relative to total plasma radioligand
|
Baseline/pre hydrocortisone and 3-hours post hydrocortisone
|
|
Orbitofrontal Cortex DELTA VT
Tidsramme: Baseline/pre hydrocortisone and 3-hours post hydrocortisone
|
VT is the volume of distribution expressed relative to total plasma radioligand
|
Baseline/pre hydrocortisone and 3-hours post hydrocortisone
|
|
Relapse to alcohol
Tidsramme: over 8-weeks follow up
|
Abstained; Relapsed; Drop-out
|
over 8-weeks follow up
|
|
Relapse to alcohol severity (self-reported)
Tidsramme: over 8- week follow up
|
Heavy drinking days/week and Abstinent days/week
|
over 8- week follow up
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceived Stress Scale
Tidsramme: over 8-week follow up
|
mean and peak scores during follow-up
|
over 8-week follow up
|
|
Penn Alcohol Craving Scale
Tidsramme: over 8-week follow up
|
mean and peak score during follow up
|
over 8-week follow up
|
|
Plasma cortisol
Tidsramme: Baseline/pre hydrocortisone and post-hydrocortisone
|
Plasma cortisol measured in blood
|
Baseline/pre hydrocortisone and post-hydrocortisone
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Rajesh Narendran, University of Pittsburgh
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juni 2026
Primær færdiggørelse (Anslået)
30. juni 2031
Studieafslutning (Anslået)
30. juni 2032
Datoer for studieregistrering
Først indsendt
16. maj 2026
Først indsendt, der opfyldte QC-kriterier
22. maj 2026
Først opslået (Faktiske)
29. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Stof-relaterede lidelser
- Kemisk inducerede lidelser
- Alkohol-relaterede lidelser
- Alkoholisme
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Polycykliske forbindelser
- Graviditet
- Steroider
- SMUSED-RING-forbindelser
- Graviderede
- Gravidser
- 11-hydroxycorticosteroider
- Hydroxycorticosteroider
- Adrenal cortexhormoner
- 17-hydroxycorticosteroider
- Hydrocortison
- Baseline tandcement
Andre undersøgelses-id-numre
- STUDY25050039
- R01AA032487 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
All individual participant data that underlie the results reported in the publication or upon study completion will be shared after de-identification via the NIAAA Data Archive
IPD-delingstidsramme
Upon publication or study completion.
Data will be available indefinitely on the data archives
IPD-delingsadgangskriterier
Available as per the NIAAA Data Archive repository criteria for access
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .