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RecruitingNCT07773649Updated Sep 14, 2026

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

An Early Phase 1 interventional study of [F-18]BCPP-EF in Cocaine Use Disorder and Healthy Controls Group - Age and Sex-matched, sponsored by Rajesh Narendran. Recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Rajesh Narendran · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
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Study summary

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

Read the 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)"

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Conditions studied

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

Keywords

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

Lead sponsor

Rajesh Narendran is the lead sponsor of 7 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Cocaine use disorders (CUD)

  1. Males or females between 18 and 45 years old.
  2. fulfill 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    PET

    \[F-18\]BCPP-EF

    Drug: [F-18]BCPP-EF

Interventions

  • Drug[F-18]BCPP-EF

    Radiotracer

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What researchers measure

Primary outcomes

  1. Orbitofrontal Cortex [F-18]BCPP-EF VT

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

    Time frame: Baseline scan (time 0)

  2. Midbrain [F-18]BCPP-EF VT

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

    Time frame: Baseline scan (time 0)

  3. Ventral Striatum [F-18]BCPP-EF VT

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

    Time frame: Baseline scan (time 0)

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Yes — 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

Supporting information: 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

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07773649
Lead sponsor
Rajesh Narendran
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Rajesh Narendran (Professor of Radiology and Psychiatry, University of Pittsburgh) — Sponsor-investigator
First posted
Aug 19, 2026
Start date
Sep 4, 2026
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Sep 14, 2026

Study contacts

Rajesh Narendran
Contact
narendranr@upmc.edu
412-647-5176
Rajesh Narendran
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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