Imaging CRF X NOP Interactions in CUD
ConditionCocaine Use Disorder
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorRajesh Narendran
About this trial
This study uses \[11C\]NOP-1A positron emission tomography (PET) and a hydrocortisone challenge to image the interaction between nociceptive opioid peptide (NOP) receptors and cortisol/corticotrophin releasing factor (CRF) in subjects with cocaine use disorders (CUD) and matched healthy controls (HC). It will also examine whether alterations in CRF x NOP interactions predict relapse in subjects with CUD.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males or females between 18 and 55 years old
Fulfil DSM-5 criteria for cocaine use disorder
No other current DSM-5 psychiatric or addictive disorders (such as major depressive disorder, bipolar disorders, psychotic disorders, etc.,)
No current abuse (six months) of opiates, sedative-hypnotics, amphetamines, MDMA, etc., as well as moderate to severe alcohol or cannabis use (twice a week). Nicotine use will be quantified and controlled between groups using the Fagerstrom Test for Nicotine Dependence (Heatherton et al., 1991);
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Baseline [C-11]NOP-1A PET Scan
RadiationRadiotracer
Hydrocortisone
DrugIntravenous, 1mg/Kg
Post-hydrocortisone [C-11]NOP-1A PET Scan
RadiationRadiotracer
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: PETExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
DELTA VT
VT is the volumes of distribution expressed relative to total plasma ligand concentration; Delta VT is the change in VT from baseline to 3-hours post-hydrocortisone.
Time frame
Baseline, and 3 hours 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 Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov