RecruitingAccepts healthy volunteersEarly Phase 1
Imaging Mitochondrial Complex-I in Cocaine Use Disorder: a [F-18]BCPP-EF PET Study
Rajesh Narendran · with National Institute on Drug Abuse (NIDA) · NCT07773649
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Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–45 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Early Phase 1
- Target enrollment
- 40
- US sites recruiting
- 1
- Study start
- September 4, 2026
- Record last updated
- September 14, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
Studies proposed in this application will image mitochondrial Complex-I in cocaine use disorder (CUD) and matched healthy controls
Being studied: [F-18]BCPP-EF
Conditions: Cocaine Use Disorder; Healthy Controls Group - Age and Sex-matched
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
University of Pittsburgh
Pittsburgh, PA 15213
Study contacts (from the official record)
- Rajesh Narendran · 412-647-5176 · narendranr@upmc.edu
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