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

NCT07773649 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: STUDY24020158R61DA062821
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cocaine Use Disorder; Healthy Controls Group - Age and Sex-matched

Keywords

[F-18]BCPP-EF PET, Mitochondrial complex-I

Outcome Measures

Primary Outcomes (3)

• Orbitofrontal Cortex [F-18]BCPP-EF VT

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

  Baseline scan (time 0)

• Midbrain [F-18]BCPP-EF VT

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

  Baseline scan (time 0)

• Ventral Striatum [F-18]BCPP-EF VT

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

  Baseline scan (time 0)

Study Arms (1)

PET

EXPERIMENTAL

\[F-18\]BCPP-EF

Drug: [F-18]BCPP-EF

Interventions

[F-18]BCPP-EF DRUG

Radiotracer

PET

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rajesh Narendran: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Study Officials

• Rajesh Narendran

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajesh Narendran

CONTACT

412-647-5176; narendranr@upmc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology and Psychiatry

Model Details: CUD and healthy controls will receive the same intervention

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon publication or study completion Data will be available as long as it is archived and per Open Neuro PET policy
• Access Criteria: Available as per Open Neuro PET repository access policy

Locations

US (1)