- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07825818
Imaging Mitochondrial Complex-I in Alcohol Use Disorder
11. september 2026 oppdatert av: Rajesh Narendran
Imaging Mitochondrial Complex-I With [F-18]BCPP-EF Positron Emission Tomography (PET) in Alcohol Use Disorder (AUD)
Studies proposed in this application will image mitochondrial Complex-I (MCI-I) and cerebral glucose metabolism (CGM) in alcohol use disorder (AUD) and matched healthy controls
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
This study uses [18F]BCPP-EF and [18F]FDG positron emission tomography (PET) to image mitochondrial complex I and cerebral glucose metabolism (CGM) in subjects with alcohol use disorder (AUD) and healthy controls (HC).
Correlating PET outcome measures with relapse to alcohol in this study will clarify the mechanisms by which abnormal brain energetics modulate addictive behaviors.
Studietype
Intervensjonell
Registrering (Antatt)
100
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
-
Ta kontakt med:
- Principal Investigator
- Telefonnummer: 412-647-5176
- E-post: narendranr@upmc.edu
-
-
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
Alcohol use disorders (AUD)
- Males or females between 18 and 55 years old
- fulfill DSM-5 criteria for alcohol use disorder
- History of NIAAA heavy drinking (for males, routinely consuming more than 4 drinks on any day or more than 14 drinks per week; for females, routinely consuming more than 3 drinks on any day or more than 7 drinks per week) in the past 30 days
- No other major DSM-5 psychiatric disorders including schizophrenia, schizoaffective disorder, bipolar disorder, developmental disorders, or current depressive disorders (unless they are related to alcohol intoxication, withdrawal, or an alcohol- induced mood disorder).
- No other DSM-5 substance use disorders including opioids, cocaine, amphetamines, sedative-hypnotics, hallucinogens, and inhalants. Subjects with moderate and severe DSM-5 cannabis and tobacco use disorder will also be excluded;
- Subjects not currently on psychotropic or medical medications that can influence binding to MC-I (e.g., metformin) or CGM (e.g., insulin, GLP-1 agonists), or increase the risks associated with an arterial line (e.g., warfarin, clopidogrel, aspirin, naproxen, ibuprofen, etc.).
- No medical disorders that can influence the PET outcome measures (for example, MC-I binding is altered in Parkinson's disease, mild or major neurocognitive disorders, and mitochondrial disorders; CGM is altered in diabetes, severe hyperlipidemia, hypertension, obesity), increase the risks associated with blood sampling (anemia), or placement of an arterial line (history of deep vein thrombosis, pulmonary embolism, thrombocytopenia or thrombocytosis) for PET
- Not currently pregnant or breast-feeding
- 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 the previous radioactive drug study [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 medical or psychiatric contraindications to undergo an MRI scan (such as ferromagnetic tattoos/piercings, implants, medical equipment, history of gunshot, and claustrophobia).
Healthy controls (HC)
- Males or females between 18 and 55 years old
- No current or past DSM-5 psychiatric or substance use disorders other than tobacco use disorder
- No history of heavy drinking as defined using NIAAA criteria in the past year
- 5 to 10 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: PET
Positron Emission Tomography Scans
|
Radiotracer to measure binding to mitochondria complex -I
Radiotracer to measure cerebral glucose metabolism
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Dorsolateral prefrontal cortex [F-18]BCPP-EF VT
Tidsramme: Baseline scan (time 0)
|
VT is the volume of distribution expressed relative to total plasma radioligand concentration, mL/cm3
|
Baseline scan (time 0)
|
|
Orbitofrontal cortex [F-18]BCPP-EF VT
Tidsramme: Baseline scan (time 0)
|
VT is the volume of distribution expressed relative to total plasma radioligand concentration in mL/cm3
|
Baseline scan (time 0)
|
|
Medial Prefrontal Cortex [F-18]BCPP-EF VT
Tidsramme: Baseline scan (time 0)
|
VT is the volume of distribution expressed relative to total plasma radioligand concentration, mL/cm3
|
Baseline scan (time 0)
|
|
Dorsolateral prefrontal cortex [F-18]FDG SUVR
Tidsramme: Baseline scan (time 0)
|
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless
|
Baseline scan (time 0)
|
|
Orbitofrontal cortex [F-18]FDG SUVR
Tidsramme: Baseline scan (time 0)
|
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless
|
Baseline scan (time 0)
|
|
Medial Prefrontal Cortex [F-18]FDG SUVR
Tidsramme: Baseline scan (time 0)
|
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless
|
Baseline scan (time 0)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Relapse to alcohol severity measure
Tidsramme: during 8-week follow up
|
Total number of ETG-negative urines (0 to 16)
|
during 8-week follow up
|
|
Penn Alcohol Craving Scale (PACS)
Tidsramme: during 8-week follow up
|
Mean weekly PACS scores (range 0 to 30; higher scores indicate more craving)
|
during 8-week follow up
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Categorical relapse to alcohol
Tidsramme: 8-week follow up
|
Abstained v Relapsed v Drop-out
|
8-week follow up
|
|
TIme to relapse
Tidsramme: during 8 week follow up
|
in weeks (0 to 8)
|
during 8 week follow up
|
|
Perceived Stress Scale (PSS)
Tidsramme: during 8-week follow up
|
Mean weekly PSS scores (0 to 40; higher scores indicate more stress)
|
during 8-week follow up
|
|
Prefrontal Cortical Thickness
Tidsramme: Baseline scan (time 0)
|
MRI-derived cortical thickness measure derived using FreeSurfer, in mm
|
Baseline scan (time 0)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Rajesh Narendran, MD, 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 (Antatt)
30. september 2026
Primær fullføring (Antatt)
31. desember 2032
Studiet fullført (Antatt)
31. desember 2032
Datoer for studieregistrering
Først innsendt
11. september 2026
Først innsendt som oppfylte QC-kriteriene
11. september 2026
Først lagt ut (Faktiske)
17. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY24030081
- R01AA031453-01A1 (Annet stipend/finansieringsnummer: NIAAA)
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 NIAAA Data Archive
IPD-delingstidsramme
Upon publication or study completion Data will be available as long as it is archived as per NIAAA Data Archive policy
Tilgangskriterier for IPD-deling
Aavailable as per NIAAA Data Archive policy
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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