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NCT Number: NCT07825818

Imaging Mitochondrial Complex-I in Alcohol Use Disorder

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of PIttsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Principal Investigator

CONTACT

[email protected]

412-647-5176

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Alcohol use disorders (AUD)

  • Males or females between 18 and 55 years old
  • fulfill DSM-5 criteria for alcohol use disorder
  • 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
  • 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).
  • 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;
  • 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.).
  • 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
  • Not currently pregnant or breast-feeding
  • 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
  • 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)

  • Males or females between 18 and 55 years old
  • No current or past DSM-5 psychiatric or substance use disorders other than tobacco use disorder
  • No history of heavy drinking as defined using NIAAA criteria in the past year
  • 5 to 10 above.

Treatment and study plan

[F-18]BCPP-EF

Drug

Radiotracer to measure binding to mitochondria complex -I

[F-18]FDG

Drug

Radiotracer to measure cerebral glucose metabolism

Primary outcomes

  1. Dorsolateral prefrontal cortex [F-18]BCPP-EF VT

    Time frame: Baseline scan (time 0)

    VT is the volume of distribution expressed relative to total plasma radioligand concentration, mL/cm3

  2. Orbitofrontal cortex [F-18]BCPP-EF VT

    Time frame: Baseline scan (time 0)

    VT is the volume of distribution expressed relative to total plasma radioligand concentration in mL/cm3

  3. Medial Prefrontal Cortex [F-18]BCPP-EF VT

    Time frame: Baseline scan (time 0)

    VT is the volume of distribution expressed relative to total plasma radioligand concentration, mL/cm3

  4. Dorsolateral prefrontal cortex [F-18]FDG SUVR

    Time frame: Baseline scan (time 0)

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

  5. Orbitofrontal cortex [F-18]FDG SUVR

    Time frame: Baseline scan (time 0)

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

  6. Medial Prefrontal Cortex [F-18]FDG SUVR

    Time frame: Baseline scan (time 0)

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

Secondary outcomes

  1. Relapse to alcohol severity measure

    Time frame: during 8-week follow up

    Total number of ETG-negative urines (0 to 16)

  2. Penn Alcohol Craving Scale (PACS)

    Time frame: during 8-week follow up

    Mean weekly PACS scores (range 0 to 30; higher scores indicate more craving)

Other outcomes

  1. Categorical relapse to alcohol

    Time frame: 8-week follow up

    Abstained v Relapsed v Drop-out

  2. TIme to relapse

    Time frame: during 8 week follow up

    in weeks (0 to 8)

  3. Perceived Stress Scale (PSS)

    Time frame: during 8-week follow up

    Mean weekly PSS scores (0 to 40; higher scores indicate more stress)

  4. Prefrontal Cortical Thickness

    Time frame: Baseline scan (time 0)

    MRI-derived cortical thickness measure derived using FreeSurfer, in mm

Study contacts

Contact information is provided by the study sponsor or research team.

Rajesh Narendran

CONTACT

[email protected]

412-647-5176

Sponsors and collaborators

Lead sponsor

Rajesh Narendran

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Imaging Mitochondrial Complex-I With [F-18]BCPP-EF Positron Emission Tomography (PET) in Alcohol Use Disorder (AUD)

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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