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NCT Number: NCT07773649

Imaging Mitochondrial Complex-I in Cocaine Use Disorder: a [F-18]BCPP-EF PET Study

Studies proposed in this application will image mitochondrial Complex-I in cocaine use disorder (CUD) and matched healthy controls

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Key information

Age range

18 year–45 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

About this study

This study uses [18F]BCPP-EF positron emission tomography (PET) to image mitochondrial complex-I in subjects with cocaine use disorder (CUD) and healthy controls (HC). Correlating PET outcome measures with relapse to cocaine in this study will clarify the mechanisms by which abnormal brain energetics modulate addictive behaviors.

This study is supported by "the NIH The Helping to End Addiction Long-term® Initiative, HEAL Initiative (https://www.nih.gov/heal)"

Who can participate

Healthy volunteers accepted: Yes

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

Cocaine use disorders (CUD)

  • Males or females between 18 and 45 years old.
  • fulfill DSM-5 criteria for moderate or severe (4+ criteria) cocaine use disorder.
  • No lifetime DSM-5 schizophrenia, schizoaffective disorder, bipolar disorder, and developmental disorders.
  • No comorbid DSM-5 major depressive or severe anxiety disorders (including cocaine-induced mood and anxiety disorders) in the past 12 months.
  • No comorbid DSM-5 alcohol, opioids, sedative-hypnotics, hallucinogens, and inhalant use disorders in the past 12 months. Subjects with a moderate to severe DSM-5 cannabis use disorder will also be excluded.
  • 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 comorbid medical disorders that can influence the PET outcome measures (for example, MC-I binding is altered in Parkinson' disease, mild or major neurocognitive disorders, mitochondrial disorders, immune disorders; and CGM is altered in diabetes, severe hyperlipidemia, hypertension, obesity), or are a contraindication for blood sampling (anemia), or placement of an arterial line (history of deep vein thrombosis, pulmonary embolism, thrombocytopenia or thrombocytosis).
  • Not currently pregnant or breast-feeding.
  • Not currently employed as radiation worker; or has not participated in a radiation-related research protocol within the previous year such that the total cumulative annual radiation dose (i.e., from participation in previous radioactive drug 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 45 years old.
  • No DSM-5 psychiatric or substance use disorder other than tobacco use disorder
  • 6 to 10 above.

Treatment and study plan

[F-18]BCPP-EF

Drug

Radiotracer

Primary outcomes

  1. 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

  2. Midbrain [F-18]BCPP-EF VT

    Time frame: Baseline scan (time 0)

    VT is the volume of distribution expressed relative to total plasma radioligand concentration

  3. Ventral Striatum [F-18]BCPP-EF VT

    Time frame: Baseline scan (time 0)

    VT is the volume of distribution expressed relative to total plasma radioligand concentration

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 Drug Abuse (NIDA)

Registry information

Official study title

Imaging Brain Energy Use in Cocaine Use Disorder: a [F-18]BCPP-EF PET Study

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 19, 2026
Registry last updated
Aug 19, 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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