NCT07773649EARLY_PHASE1RecruitingAccepts Healthy Volunteers
Imaging Mitochondrial Complex-I in Cocaine Use Disorder: a [F-18]BCPP-EF PET Study
Rajesh Narendran
Start Date
9/4/2026
Completion Date
12/31/2029
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)"
Eligibility Criteria
Age Range: 18 years to 45 years
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.
Interventions
DRUG
[F-18]BCPP-EF
Conditions
Cocaine Use DisorderHealthy Controls Group - Age and Sex-matched
Locations
University of Pittsburgh
Pittsburgh, Pennsylvania 15213
United States