Purpose

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

Conditions

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
CUD and healthy controls will receive the same intervention
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PET
[F-18]BCPP-EF
  • Drug: [F-18]BCPP-EF
    Radiotracer

Recruiting Locations

University of Pittsburgh
Pittsburgh, Pennsylvania 15213

More Details

Status
Recruiting
Sponsor
Rajesh Narendran

Study Contact

Rajesh Narendran
412-647-5176
narendranr@upmc.edu

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-termĀ® Initiative, HEAL Initiative (https://www.nih.gov/heal)"

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.