Imaging CRF X NOP Interactions in Alcohol Use Disorder
ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorRajesh Narendran
About this trial
This positron emission tomography imaging study uses \[C-11\]NOP-1A and hydrocortisone to image stress-modulating proteins in heavy drinking alcohol use disorder (AUD) subjects and healthy controls (HC). It will also characterize the role of these stress-regulating proteins in a relapse to alcohol.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males or females between 18 and 55 years old
fulfill DSM-5 criteria for moderate or severe ( > or = 4 criteria) alcohol use disorder
fulfill both NIAAA heavy drinking91 (consuming for males > or = 5 drinks on any day; for females > or = 4 drinks on any day) and WHO high-risk/very high-risk drinking level criteria66 (for males > or = 30 drinks/week; for females > or = 20 drinks/week) in the past four weeks prior to enrollment
No lifetime DSM-5 psychiatric disorders, including schizophrenia, schizoaffective disorder, bipolar disorder, or developmental disorders.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Baseline [C-11]NOP-1A PET scan
RadiationRadiotracer
Hydrocortisone
DrugIntravenous, 1 mg/Kg
Post-hydrocortisone [C-11]NOP-1A PET scan
RadiationRadiotracer
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: PETExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Amygdala DELTA VT
VT is the volume of distribution expressed relative to total plasma radioligand concentration; DELTA VT is the change from baseline to post-hydrocortisone
Time frame
Baseline/pre hydrocortisone, and 3-hours post hydrocortisone2
Total number of negative ETG tests
Represents level of abstinence in contingency management
Time frame
over 8-week follow-upSecondary outcomes
1
Midbrain DELTA VT
VT is the volume of distribution expressed relative to total plasma radioligand
Time frame
Baseline/pre hydrocortisone and 3-hours post hydrocortisone2
Ventral striatum DELTA VT
VT is the volume of distribution expressed relative to total plasma radioligand
Time frame
Baseline/pre hydrocortisone and 3-hours post hydrocortisone3
Orbitofrontal Cortex DELTA VT
VT is the volume of distribution expressed relative to total plasma radioligand
Time frame
Baseline/pre hydrocortisone and 3-hours post hydrocortisone4
Relapse to alcohol
Abstained; Relapsed; Drop-out
Time frame
over 8-weeks follow upOther outcomes
1
Perceived Stress Scale
mean and peak scores during follow-up
Time frame
over 8-week follow up2
Penn Alcohol Craving Scale
mean and peak score during follow up
Time frame
over 8-week follow up3
Plasma cortisol
Plasma cortisol measured in blood
Time frame
Baseline/pre hydrocortisone and post-hydrocortisoneSponsors 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