An Early Phase 1 interventional study of [F-18]BCPP-EF and [F-18]FDG in Alcohol Use Disorder (AUD) 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 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Rajesh Narendran · Early Phase 1, Interventional, and Basic science
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
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.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 100 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →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.
Alcohol use disorders (AUD)
Healthy controls (HC)
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Positron Emission Tomography Scans
Drug: [F-18]BCPP-EF · Drug: [F-18]FDG
Radiotracer to measure binding to mitochondria complex -I
Radiotracer to measure cerebral glucose metabolism
Dorsolateral prefrontal cortex [F-18]BCPP-EF VT
VT is the volume of distribution expressed relative to total plasma radioligand concentration, mL/cm3
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline scan (time 0)
Relapse to alcohol severity measure
Total number of ETG-negative urines (0 to 16)
Time frame: during 8-week follow up
Penn Alcohol Craving Scale (PACS)
Mean weekly PACS scores (range 0 to 30; higher scores indicate more craving)
Time frame: during 8-week follow up
Categorical relapse to alcohol
Abstained v Relapsed v Drop-out
Time frame: 8-week follow up
TIme to relapse
in weeks (0 to 8)
Time frame: during 8 week follow up
Perceived Stress Scale (PSS)
Mean weekly PSS scores (0 to 40; higher scores indicate more stress)
Time frame: during 8-week follow up
Prefrontal Cortical Thickness
MRI-derived cortical thickness measure derived using FreeSurfer, in mm
Time frame: Baseline scan (time 0)
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 NIAAA Data Archive
Supporting information: Study protocol
Time frame: Upon publication or study completion Data will be available as long as it is archived as per NIAAA Data Archive policy
Access criteria: Aavailable as per NIAAA Data Archive policy
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Fluorodeoxyglucose F18
Rajesh Narendran