Imaging Mitochondrial Complex-I in Alcohol Use Disorder
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorRajesh Narendran
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
[F-18]BCPP-EF
DrugRadiotracer to measure binding to mitochondria complex -I
[F-18]FDG
DrugRadiotracer to measure cerebral glucose metabolism
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: PETExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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)Secondary outcomes
1
Relapse to alcohol severity measure
Total number of ETG-negative urines (0 to 16)
Time frame
during 8-week follow up2
Penn Alcohol Craving Scale (PACS)
Mean weekly PACS scores (range 0 to 30; higher scores indicate more craving)
Time frame
during 8-week follow upOther outcomes
1
Categorical relapse to alcohol
Abstained v Relapsed v Drop-out
Time frame
8-week follow up2
TIme to relapse
in weeks (0 to 8)
Time frame
during 8 week follow up3
Perceived Stress Scale (PSS)
Mean weekly PSS scores (0 to 40; higher scores indicate more stress)
Time frame
during 8-week follow up4
Prefrontal Cortical Thickness
MRI-derived cortical thickness measure derived using FreeSurfer, in mm
Time frame
Baseline scan (time 0)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rajesh Narendran
Lead sponsor
University of Pittsburgh
Sponsor institution
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov