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

ArmDescriptionAssigned Intervention
Experimental
PET
Positron Emission Tomography Scans
  • Drug: [F-18]BCPP-EF
    Radiotracer to measure binding to mitochondria complex -I
  • Drug: [F-18]FDG
    Radiotracer to measure cerebral glucose metabolism

Recruiting Locations

University of PIttsburgh
Pittsburgh, Pennsylvania 15213
Contact:
Principal Investigator
412-647-5176
narendranr@upmc.edu

More Details

Status
Recruiting
Sponsor
Rajesh Narendran

Study Contact

Rajesh Narendran
412-647-5176
narendranr@upmc.edu

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.