Skip to content

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07773649
Enrollment
40
Registered
2026-08-19
Start date
2026-09-04
Completion date
2029-12-31
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

Brief summary

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

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)"

Interventions

Radiotracer

Sponsors

Rajesh Narendran
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

CUD and healthy controls will receive the same intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Orbitofrontal Cortex [F-18]BCPP-EF VTBaseline scan (time 0)VT is the volume of distribution expressed relative to total plasma radioligand concentration
Midbrain [F-18]BCPP-EF VTBaseline scan (time 0)VT is the volume of distribution expressed relative to total plasma radioligand concentration
Ventral Striatum [F-18]BCPP-EF VTBaseline scan (time 0)VT is the volume of distribution expressed relative to total plasma radioligand concentration

Countries

United States

Contacts

CONTACTRajesh Narendran
narendranr@upmc.edu412-647-5176
PRINCIPAL_INVESTIGATORRajesh Narendran

University of Pittsburgh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026