Imaging Mitochondrial Complex-I and Brain Metabolism in Alcohol Use Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase PET study uses [18F]BCPP-EF to image mitochondrial complex I activity and [18F]FDG to measure cerebral glucose metabolism in adults with alcohol use disorder and age- and sex-matched healthy controls. Participants will undergo PET imaging to compare brain energetics between groups. Researchers will examine whether PET measures correlate with relapse to alcohol use, contributing to understanding of how brain energy dynamics may influence addictive behaviors. The study is led by Rajesh Narendran with NIAAA collaboration at the University of Pittsburgh. Participants are adults aged 18-55 who meet DSM-5 criteria for AUD and meet specific drinking history thresholds, with careful exclusion of comorbid psychiatric or substance use disorders that could affect imaging outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of PIttsburgh
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Rajesh Narendran, MD — University of Pittsburgh
• Study coordinator: Rajesh Narendran
• Email: narendranr@upmc.edu
• Phone: 412-647-5176

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.