Alcohol Use Disorder (AUD)Early Phase 1NCT07825818
Imaging Mitochondrial Complex-I in Alcohol Use Disorder
A Early Phase 1 study testing [F-18]BCPP-EF and [F-18]FDG in people with Alcohol Use Disorder (AUD) 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 (MCI-I) and cerebral glucose metabolism (CGM) in alcohol use disorder (AUD) and matched healthy controls Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder (AUD), Healthy Controls Group - Age and Sex-matched
- What is being tested?
- [F-18]BCPP-EF and [F-18]FDG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 31 Dec 2032
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Alcohol use disorders (AUD)
- Males or females between 18 and 55 years old
- fulfill DSM-5 criteria for alcohol use disorder
- History of NIAAA heavy drinking (for males, routinely consuming more than 4 drinks on any day or more than 14 drinks per week; for females, routinely consuming more than 3 drinks on any day or more than 7 drinks per week) in the past 30 days
- No other major DSM-5 psychiatric disorders including schizophrenia, schizoaffective disorder, bipolar disorder, developmental disorders, or current depressive disorders (unless they are related to alcohol intoxication, withdrawal, or an alcohol- induced mood disorder).
- No other DSM-5 substance use disorders including opioids, cocaine, amphetamines, sedative-hypnotics, hallucinogens, and inhalants. Subjects with moderate and severe DSM-5 cannabis and tobacco use disorder will also be excluded;
- Subjects 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 medical disorders that can influence the PET outcome measures (for example, MC-I binding is altered in Parkinson's disease, mild or major neurocognitive disorders, and mitochondrial disorders; CGM is altered in diabetes, severe hyperlipidemia, hypertension, obesity), increase the risks associated with blood sampling (anemia), or placement of an arterial line (history of deep vein thrombosis, pulmonary embolism, thrombocytopenia or thrombocytosis) for PET
- Not currently pregnant or breast-feeding
- Not currently employed as a radiation worker; or has participated in a radiation-related research protocol within the previous year such that the total cumulative annual radiation dose (i.e., from participation in the previous radioactive drug study [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 55 years old
- No current or past DSM-5 psychiatric or substance use disorders other than tobacco use disorder
- No history of heavy drinking as defined using NIAAA criteria in the past year
- 5 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
Principal Investigator, 412-647-5176, narendranr@upmc.edu
About this study
Official title: Imaging Mitochondrial Complex-I With [F-18]BCPP-EF Positron Emission Tomography (PET) in Alcohol Use Disorder (AUD)
Studies proposed in this application will image mitochondrial Complex-I (MCI-I) and cerebral glucose metabolism (CGM) in alcohol use disorder (AUD) and matched healthy controls
Read the detailed description
This study uses [18F]BCPP-EF and [18F]FDG positron emission tomography (PET) to image mitochondrial complex I and cerebral glucose metabolism (CGM) in subjects with alcohol use disorder (AUD) and healthy controls (HC). Correlating PET outcome measures with relapse to alcohol in this study will clarify the mechanisms by which abnormal brain energetics modulate addictive behaviors.
- Being tested
- [F-18]BCPP-EF, [F-18]FDG
- Keywords
- PET, [F-18]BCPP-EF, [F-18]FDG, Alcohol use disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18]BCPP-EFDrug
Radiotracer to measure binding to mitochondria complex -I
[F-18]FDGDrug
Radiotracer to measure cerebral glucose metabolism
| Study group | Role | What they receive |
|---|---|---|
| PET | Experimental | Positron Emission Tomography Scans Receives: Drug: [F-18]BCPP-EF; Drug: [F-18]FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dorsolateral prefrontal cortex [F-18]BCPP-EF VT
VT is the volume of distribution expressed relative to total plasma radioligand concentration, mL/cm3
Measured: Baseline scan (time 0)
Orbitofrontal cortex [F-18]BCPP-EF VT
VT is the volume of distribution expressed relative to total plasma radioligand concentration in mL/cm3
Measured: Baseline scan (time 0)
Medial Prefrontal Cortex [F-18]BCPP-EF VT
VT is the volume of distribution expressed relative to total plasma radioligand concentration, mL/cm3
Measured: Baseline scan (time 0)
Dorsolateral prefrontal cortex [F-18]FDG SUVR
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless
Measured: Baseline scan (time 0)
Orbitofrontal cortex [F-18]FDG SUVR
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless
Measured: Baseline scan (time 0)
Medial Prefrontal Cortex [F-18]FDG SUVR
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless
Measured: Baseline scan (time 0)
Secondary outcomes (2)
Relapse to alcohol severity measure
Total number of ETG-negative urines (0 to 16)
Measured: during 8-week follow up
Penn Alcohol Craving Scale (PACS)
Mean weekly PACS scores (range 0 to 30; higher scores indicate more craving)
Measured: during 8-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies 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
- AUD and HC will receive the same intervention
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rajesh Narendran
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Rajesh Narendran, University of Pittsburgh
- Investigators
- Rajesh Narendran, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825818
- Sponsor's protocol ID
- STUDY24030081
- Other IDs
- R01AA031453-01A1
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 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 NIAAA Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Mitochondrial Complex-I With [F-18]BCPP-EF Positron Emission Tomography (PET) in Alcohol Use Disorder (AUD)
- ClinicalTrials.gov ID
- NCT07825818
- Acronym / sponsor ID
- STUDY24030081
- Keywords
- PET, [F-18]BCPP-EF, [F-18]FDG, Alcohol use disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rajesh NarendranUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 17 Sep 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 (MCI-I) and cerebral glucose metabolism (CGM) in alcohol use disorder (AUD) and matched healthy controls
Detailed description
This study uses [18F]BCPP-EF and [18F]FDG positron emission tomography (PET) to image mitochondrial complex I and cerebral glucose metabolism (CGM) in subjects with alcohol use disorder (AUD) and healthy controls (HC). Correlating PET outcome measures with relapse to alcohol in this study will clarify the mechanisms by which abnormal brain energetics modulate addictive behaviors.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- AUD and HC will receive the same intervention
| Arm | Type | Receives |
|---|---|---|
| PET | Experimental | Drug: [F-18]BCPP-EF, Drug: [F-18]FDGPositron Emission Tomography Scans |
Who may qualify
- Ages
- 18 to 55 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 to measure binding to mitochondria complex -I | Drug | PET |
| [F-18]FDGRadiotracer to measure cerebral glucose metabolism | Drug | PET |
Primary outcome
Dorsolateral prefrontal 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, mL/cm3
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 in mL/cm3
Medial Prefrontal 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, mL/cm3
Dorsolateral prefrontal cortex [F-18]FDG SUVR
Time frame: Baseline scan (time 0)
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless
Orbitofrontal cortex [F-18]FDG SUVR
Time frame: Baseline scan (time 0)
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless
Medial Prefrontal Cortex [F-18]FDG SUVR
Time frame: Baseline scan (time 0)
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless
2 secondary outcomes
Relapse to alcohol severity measure
Time frame: during 8-week follow up
Penn Alcohol Craving Scale (PACS)
Time frame: during 8-week follow up
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 17 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 NIAAA Data Archive
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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, MD 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 and [F-18]FDG in people with Alcohol Use Disorder (AUD) 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 17 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?
Dorsolateral prefrontal cortex [F-18]BCPP-EF VT (time frame: Baseline scan (time 0)). The study lists 6 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 17 Sep 2026.