Alcohol Use Disorder (AUD), Healthy Controls Group - Age and Sex-matched
Conditions
Keywords
PET, [F-18]BCPP-EF, [F-18]FDG, Alcohol use disorder
Brief summary
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
Detailed description
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.
Interventions
DRUG[F-18]BCPP-EF
Radiotracer to measure binding to mitochondria complex -I
DRUG[F-18]FDG
Radiotracer to measure cerebral glucose metabolism
Sponsors
Rajesh Narendran
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
AUD and HC will receive the same intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Alcohol use disorders (AUD) 1. Males or females between 18 and 55 years old 2. fulfill DSM-5 criteria for alcohol use disorder 3. 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 4. 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). 5. 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; 6. 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.). 7. 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 8. Not currently pregnant or breast-feeding 9. 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 10. 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) 1. Males or females between 18 and 55 years old 2. No current or past DSM-5 psychiatric or substance use disorders other than tobacco use disorder 3. No history of heavy drinking as defined using NIAAA criteria in the past year 4. 5 to 10 above.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dorsolateral prefrontal cortex [F-18]BCPP-EF VT | Baseline scan (time 0) | VT is the volume of distribution expressed relative to total plasma radioligand concentration, mL/cm3 |
| Orbitofrontal cortex [F-18]BCPP-EF VT | Baseline scan (time 0) | VT is the volume of distribution expressed relative to total plasma radioligand concentration in mL/cm3 |
| Medial Prefrontal Cortex [F-18]BCPP-EF VT | Baseline scan (time 0) | VT is the volume of distribution expressed relative to total plasma radioligand concentration, mL/cm3 |
| Dorsolateral prefrontal cortex [F-18]FDG SUVR | Baseline scan (time 0) | SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless |
| Orbitofrontal cortex [F-18]FDG SUVR | Baseline scan (time 0) | SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless |
| Medial Prefrontal Cortex [F-18]FDG SUVR | Baseline scan (time 0) | SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapse to alcohol severity measure | during 8-week follow up | Total number of ETG-negative urines (0 to 16) |
| Penn Alcohol Craving Scale (PACS) | during 8-week follow up | Mean weekly PACS scores (range 0 to 30; higher scores indicate more craving) |
Countries
United States
Contacts
CONTACTRajesh Narendran
PRINCIPAL_INVESTIGATORRajesh Narendran, MD
University of Pittsburgh
Outcome results
None listed