Recruiting
Early Phase 1

Mitochondrial Imaging

Sponsor:

Rajesh Narendran

Code:

NCT07773649

Conditions

Cocaine Use Disorder

Healthy Controls Group - Age and Sex-matched

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

[F-18]BCPP-EF

Study Details

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

Study ID

NCT07773649

Start date

Sep 15, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: PET

\[F-18\]BCPP-EF

Interventions

[F-18]BCPP-EF

Radiotracer

Primary outcome measure

  • Orbitofrontal Cortex [F-18]BCPP-EF VT [ Time Frame: Baseline scan (time 0) ]
  • Midbrain [F-18]BCPP-EF VT [ Time Frame: Baseline scan (time 0) ]
  • Ventral Striatum [F-18]BCPP-EF VT [ Time Frame: Baseline scan (time 0) ]

Central Contacts and Locations

Central contacts

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

More Information

Sponsor

Rajesh Narendran

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rajesh Narendran on 2026-08-20.