Cocaine Use DisorderEarly Phase 1NCT07773649
Imaging Mitochondrial Complex-I in Cocaine Use Disorder: a [F-18]BCPP-EF PET Study
A Early Phase 1 study testing [F-18]BCPP-EF in people with Cocaine Use Disorder and Healthy Controls Group - Age and Sex-matched, run by Rajesh Narendran at 1 site in United States.
Trial summary
Studies proposed in this application will image mitochondrial Complex-I in cocaine use disorder (CUD) and matched healthy controls Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Use Disorder, Healthy Controls Group - Age and Sex-matched
- What is being tested?
- [F-18]BCPP-EF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2026to 31 Dec 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Cocaine use disorders (CUD)
- Males or females between 18 and 45 years old.
- fulfill DSM-5 criteria for moderate or severe (4+ criteria) cocaine use disorder.
- No lifetime DSM-5 schizophrenia, schizoaffective disorder, bipolar disorder, and developmental disorders.
- No comorbid DSM-5 major depressive or severe anxiety disorders (including cocaine-induced mood and anxiety disorders) in the past 12 months.
- 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.
- 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.).
- 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).
- Not currently pregnant or breast-feeding.
- 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.
- 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)
- Males or females between 18 and 45 years old.
- No DSM-5 psychiatric or substance use disorder other than tobacco use disorder
- 6 to 10 above.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Imaging Brain Energy Use in Cocaine Use Disorder: a [F-18]BCPP-EF PET Study
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)"
- Being tested
- [F-18]BCPP-EF
- Keywords
- [F-18]BCPP-EF PET, Mitochondrial complex-I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18]BCPP-EFDrug
Radiotracer
| Study group | Role | What they receive |
|---|---|---|
| PET | Experimental | [F-18]BCPP-EF Receives: Drug: [F-18]BCPP-EF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orbitofrontal Cortex [F-18]BCPP-EF VT
VT is the volume of distribution expressed relative to total plasma radioligand concentration
Measured: Baseline scan (time 0)
Midbrain [F-18]BCPP-EF VT
VT is the volume of distribution expressed relative to total plasma radioligand concentration
Measured: Baseline scan (time 0)
Ventral Striatum [F-18]BCPP-EF VT
VT is the volume of distribution expressed relative to total plasma radioligand concentration
Measured: Baseline scan (time 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start4 Sep 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- CUD and healthy controls will receive the same intervention
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rajesh Narendran
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Rajesh Narendran, University of Pittsburgh
- Investigators
- Rajesh Narendran, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773649
- Sponsor's protocol ID
- STUDY24020158
- Other IDs
- R61DA062821
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Brain Energy Use in Cocaine Use Disorder: a [F-18]BCPP-EF PET Study
- ClinicalTrials.gov ID
- NCT07773649
- Acronym / sponsor ID
- STUDY24020158
- Keywords
- [F-18]BCPP-EF PET, Mitochondrial complex-I
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rajesh NarendranUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Sep 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)"
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- CUD and healthy controls will receive the same intervention
| Arm | Type | Receives |
|---|---|---|
| PET | Experimental | Drug: [F-18]BCPP-EF[F-18]BCPP-EF |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [F-18]BCPP-EFRadiotracer | Drug | PET |
Primary outcome
Orbitofrontal Cortex [F-18]BCPP-EF VT
Time frame: Baseline scan (time 0)
VT is the volume of distribution expressed relative to total plasma radioligand concentration
Midbrain [F-18]BCPP-EF VT
Time frame: Baseline scan (time 0)
VT is the volume of distribution expressed relative to total plasma radioligand concentration
Ventral Striatum [F-18]BCPP-EF VT
Time frame: Baseline scan (time 0)
VT is the volume of distribution expressed relative to total plasma radioligand concentration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajesh Narendran principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [F-18]BCPP-EF in people with Cocaine Use Disorder and Healthy Controls Group - Age and Sex-matched, run by Rajesh Narendran at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajesh Narendran (412-647-5176, narendranr@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orbitofrontal Cortex [F-18]BCPP-EF VT (time frame: Baseline scan (time 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.