An Early Phase 1 interventional study of Baseline [C-11]NOP-1A PET scan and Hydrocortisone in Alcohol Use Disorder, 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 2026-06-03.
Sponsored by Rajesh Narendran · Early Phase 1, Interventional, and Basic science
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.
Hydrocortisone administration leads to a 10 to 15% increase in [11C]NOP-1A VT in brain regions, including the amygdala. Increased NOP measured in response to cortisol, and by extension, corticotrophin-releasing factor (CRF), in this paradigm reflects an individual's ability to enhance N/OFQ transmission during stress. Here, the investigators propose to use this novel imaging paradigm to compare hydrocortisone-induced increases in [11C]NOP-1A binding (DVT) in the amygdala (and secondary reward regions) in heavy drinking AUD subjects Vs. HC. The hypothesis that hydrocortisone-induced increases in [11C]NOP-1A binding (DVT) will be larger in heavy drinking AUD relative to HC (aim 1), and this will predict relapse to alcohol (aim 2). Such a result will support the presence of a hyperactive NOP receptor system in response to increases in cortisol/CRF during conditions such as stress, chronic pain, etc., promoting relapse in heavy drinking AUD subjects.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 90 is close to 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.
Heavy drinking alcohol use disorder subjects (AUD)
Healthy Control subjects (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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
\[C-11\]NOP-1A
Radiation: Baseline [C-11]NOP-1A PET scan · Drug: Hydrocortisone · Radiation: Post-hydrocortisone [C-11]NOP-1A PET scan
Radiotracer
Intravenous, 1 mg/Kg
Radiotracer
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 hydrocortisone
Total number of negative ETG tests
Represents level of abstinence in contingency management
Time frame: over 8-week follow-up
Midbrain DELTA VT
VT is the volume of distribution expressed relative to total plasma radioligand
Time frame: Baseline/pre hydrocortisone and 3-hours post hydrocortisone
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 hydrocortisone
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 hydrocortisone
Relapse to alcohol
Abstained; Relapsed; Drop-out
Time frame: over 8-weeks follow up
Relapse to alcohol severity (self-reported)
Heavy drinking days/week and Abstinent days/week
Time frame: over 8- week follow up
Perceived Stress Scale
mean and peak scores during follow-up
Time frame: over 8-week follow up
Penn Alcohol Craving Scale
mean and peak score during follow up
Time frame: over 8-week follow up
Plasma cortisol
Plasma cortisol measured in blood
Time frame: Baseline/pre hydrocortisone and post-hydrocortisone
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 the NIAAA Data Archive
Supporting information: Study protocol
Time frame: Upon publication or study completion. Data will be available indefinitely on the data archives
Access criteria: Available as per the NIAAA Data Archive repository criteria for access
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jun 2031, 60 months after the start.
Of 63 non-industry phase 1 interventional studies under Alcoholism, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 49. This study's planned 60 months is above that.
Counting every sponsor, half of 75 studies reached it within 28 months; a quarter within 19 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Hydrocortisone
Rajesh Narendran