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

Imaging Brain Energy Use 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

Study Overview

• Status: Recruiting
• Conditions: Cocaine Use Disorder; Healthy Controls Group - Age and Sex-matched
• Intervention / Treatment: Drug: [F-18]BCPP-EF

Detailed Description

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)"

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Rajesh Narendran; Phone Number: 412-647-5176; Email: narendranr@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PET; [F-18]BCPP-EF	Drug: [F-18]BCPP-EF; Radiotracer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Rajesh Narendran
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Rajesh Narendran, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 14, 2026
• First Submitted That Met QC Criteria: August 14, 2026
• First Posted (Actual): August 19, 2026

Study Record Updates

• Last Update Posted (Actual): September 14, 2026
• Last Update Submitted That Met QC Criteria: September 11, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: [F-18]BCPP-EF PET, Mitochondrial complex-I
• Other Study ID Numbers: STUDY24020158; R61DA062821 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data that underlie the results reported in the publication or upon study completion will be shared after de-identification via the Open Neuro PET
• IPD Sharing Time Frame: Upon publication or study completion Data will be available as long as it is archived and per Open Neuro PET policy
• IPD Sharing Access Criteria: Available as per Open Neuro PET repository access policy
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No