Imaging CRF X NOP Interactions in Alcohol Use Disorder
Does a Hyperactive Nociceptin Opioid Peptide Receptor System Promote Relapse in Heavy Drinking AUD Subjects: a [C-11]NOP-1A and Hydrocortisone PET Study
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiekontakt
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
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: KÆLEDYR
[C-11]NOP-1A
|
Radiotracer
Intravenous, 1 mg/Kg
Radiotracer
|
Hvad måler undersøgelsen?
Primære resultatmål
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
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
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
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Ledende efterforsker: Rajesh Narendran, University of Pittsburgh
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
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
Andre undersøgelses-id-numre
- STUDY25050039
- R01AA032487 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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