Imaging Mitochondrial Complex-I in Alcohol Use Disorder
Purpose
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
Conditions
- Alcohol Use Disorder (AUD)
- Healthy Controls Group - Age and Sex-matched
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- AUD and HC will receive the same intervention
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PET |
Positron Emission Tomography Scans |
|
Recruiting Locations
Pittsburgh, Pennsylvania 15213
More Details
- Status
- Recruiting
- Sponsor
- Rajesh Narendran
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.