Imaging Mitochondrial Complex-I in Alcohol Use Disorder

NCT07825818 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: STUDY24030081R01AA031453-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Alcohol Use Disorder (AUD); Healthy Controls Group - Age and Sex-matched

Keywords

PET; [F-18]BCPP-EF; [F-18]FDG; Alcohol use disorder

Outcome Measures

Primary Outcomes (6)

• Dorsolateral prefrontal cortex [F-18]BCPP-EF VT

  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

  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

  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

  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

  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

  SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless

  Baseline scan (time 0)

Secondary Outcomes (2)

• Relapse to alcohol severity measure

  during 8-week follow up

• Penn Alcohol Craving Scale (PACS)

  during 8-week follow up

Other Outcomes (4)

• Categorical relapse to alcohol

  8-week follow up

• TIme to relapse

  during 8 week follow up

• Perceived Stress Scale (PSS)

  during 8-week follow up

Study Arms (1)

PET

EXPERIMENTAL

Positron Emission Tomography Scans

Drug: [F-18]BCPP-EF; Drug: [F-18]FDG

Interventions

[F-18]BCPP-EF DRUG

Radiotracer to measure binding to mitochondria complex -I

PET

[F-18]FDG DRUG

Radiotracer to measure cerebral glucose metabolism

PET

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rajesh Narendran: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of PIttsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Rajesh Narendran, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajesh Narendran

CONTACT

412-647-5176; narendranr@upmc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology and Psychiatry

Model Details: AUD and HC will receive the same intervention

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon publication or study completion Data will be available as long as it is archived as per NIAAA Data Archive policy
• Access Criteria: Aavailable as per NIAAA Data Archive policy

Locations

US (1)