- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07612631
Imaging CRF X NOP Interactions in Alcohol Use Disorder
1. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
90
Fase
- Tidlig fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Rajesh Narendran
- Telefonnummer: 412-647-5176
- E-post: narendranr@upmc.edu
Studiesteder
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forente stater, 15213
- Rekruttering
- University of Pittsburgh
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: KJÆLEDYR
[C-11]NOP-1A
|
Radiotracer
Intravenous, 1 mg/Kg
Radiotracer
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Rajesh Narendran, University of Pittsburgh
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2026
Primær fullføring (Antatt)
30. juni 2031
Studiet fullført (Antatt)
30. juni 2032
Datoer for studieregistrering
Først innsendt
16. mai 2026
Først innsendt som oppfylte QC-kriteriene
22. mai 2026
Først lagt ut (Faktiske)
29. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Stoffrelaterte lidelser
- Kjemisk-induserte lidelser
- Alkoholrelaterte lidelser
- Alkoholisme
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Polysykliske forbindelser
- Gravaner
- Steroider
- Smeltede ringforbindelser
- Gravidiones
- Gravide
- 11-hydroksykortikosteroider
- Hydroksykortikosteroider
- Adrenal cortex hormoner
- 17-hydroksykortikosteroider
- Hydrokortison
- Baseline Dental Cement
Andre studie-ID-numre
- STUDY25050039
- R01AA032487 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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
Tilgangskriterier for IPD-deling
Available as per the NIAAA Data Archive repository criteria for access
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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