Recruiting
Early Phase 1

Observational Study

Sponsor:

Rajesh Narendran

Code:

NCT07825818

Conditions

Alcohol Use Disorder (AUD)

Healthy Controls Group - Age and Sex-matched

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

[F-18]BCPP-EF

[F-18]FDG

Study Details

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

Study ID

NCT07825818

Start date

Sep 30, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2032

Anticipated

Primary completion date

Dec 31, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: PET

Positron Emission Tomography Scans

Interventions

[F-18]BCPP-EF

Radiotracer to measure binding to mitochondria complex -I

[F-18]FDG

Radiotracer to measure cerebral glucose metabolism

Primary outcome measure

  • Dorsolateral prefrontal cortex [F-18]BCPP-EF VT [ Time Frame: Baseline scan (time 0) ]
  • Orbitofrontal cortex [F-18]BCPP-EF VT [ Time Frame: Baseline scan (time 0) ]
  • Medial Prefrontal Cortex [F-18]BCPP-EF VT [ Time Frame: Baseline scan (time 0) ]
  • Dorsolateral prefrontal cortex [F-18]FDG SUVR [ Time Frame: Baseline scan (time 0) ]
  • Orbitofrontal cortex [F-18]FDG SUVR [ Time Frame: Baseline scan (time 0) ]
  • Medial Prefrontal Cortex [F-18]FDG SUVR [ Time Frame: Baseline scan (time 0) ]

Central Contacts and Locations

Central contacts

Locations

University of PIttsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Principal Investigator

412-647-5176narendranr@upmc.edu

More Information

Sponsor

Rajesh Narendran

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Rajesh Narendran on 2026-09-17.