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- Klinische proef NCT07825818
Imaging Mitochondrial Complex-I in Alcohol Use Disorder
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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Vroege fase 1
Contacten en locaties
Studiecontact
- Naam: Rajesh Narendran
- Telefoonnummer: 412-647-5176
- E-mail: narendranr@upmc.edu
Studie Locaties
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- Werving
- University of PIttsburgh
-
Contact:
- Principal Investigator
- Telefoonnummer: 412-647-5176
- E-mail: narendranr@upmc.edu
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: PET
Positron Emission Tomography Scans |
Radiotracer to measure binding to mitochondria complex -I Radiotracer to measure cerebral glucose metabolism |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Dorsolateral prefrontal cortex [F-18]BCPP-EF VT
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline scan (time 0)
|
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless |
Baseline scan (time 0)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Relapse to alcohol severity measure
Tijdsspanne: during 8-week follow up
|
Total number of ETG-negative urines (0 to 16) |
during 8-week follow up
|
|
Penn Alcohol Craving Scale (PACS)
Tijdsspanne: during 8-week follow up
|
Mean weekly PACS scores (range 0 to 30; higher scores indicate more craving) |
during 8-week follow up
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Categorical relapse to alcohol
Tijdsspanne: 8-week follow up
|
Abstained v Relapsed v Drop-out |
8-week follow up
|
|
TIme to relapse
Tijdsspanne: during 8 week follow up
|
in weeks (0 to 8) |
during 8 week follow up
|
|
Perceived Stress Scale (PSS)
Tijdsspanne: 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
Tijdsspanne: Baseline scan (time 0)
|
MRI-derived cortical thickness measure derived using FreeSurfer, in mm |
Baseline scan (time 0)
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Rajesh Narendran, MD, University of Pittsburgh
Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STUDY24030081
- R01AA031453-01A1 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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-tijdsbestek voor delen
Upon publication or study completion Data will be available as long as it is archived as per NIAAA Data Archive policy
IPD-toegangscriteria voor delen
Aavailable as per NIAAA Data Archive policy
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
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