Imaging Brain Mitochondrial Complex-I in Cocaine 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

Researchers will image mitochondrial complex-I in adults with cocaine use disorder and matched healthy controls using [18F]BCPP-EF PET. The study aims to relate PET measurements of brain energy metabolism to relapse risk and cocaine-use behaviors. It is funded in part by NIH HEAL Initiative and led by Rajesh Narendran at the University of Pittsburgh in collaboration with NIDA. The results could clarify how brain energetics relate to addiction mechanisms and relapse. This is an early-phase, exploratory imaging study.

Why it matters

Who can join: the full rules

Cocaine use disorders (CUD)

1. Males or females between 18 and 45 years old.
2. fulfill DSM-5 criteria for moderate or severe (4+ criteria) cocaine use disorder.
3. No lifetime DSM-5 schizophrenia, schizoaffective disorder, bipolar disorder, and developmental disorders.
4. No comorbid DSM-5 major depressive or severe anxiety disorders (including cocaine-induced mood and anxiety disorders) in the past 12 months.
5. 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.
6. 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 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).
8. Not currently pregnant or breast-feeding.
9. 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.
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 45 years old.
2. No DSM-5 psychiatric or substance use disorder other than tobacco use disorder
3. 6 to 10 above.

Where it's running

• University of Pittsburgh
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Rajesh Narendran — 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.