AzTrials
AzTrials

Alcohol Use DisorderEarly Phase 1NCT07612631

Imaging CRF X NOP Interactions in Alcohol Use Disorder

A Early Phase 1 study testing Baseline [C-11]NOP-1A PET scan, Hydrocortisone and Post-hydrocortisone [C-11]NOP-1A PET scan in people with Alcohol Use Disorder, run by Rajesh Narendran at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Baseline [C-11]NOP-1A PET scan, Hydrocortisone and Post-hydrocortisone [C-11]NOP-1A PET scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
1 Jun 2026to 30 Jun 2032
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Heavy drinking alcohol use disorder subjects (AUD)

  1. Males or females between 18 and 55 years old
  2. fulfill DSM-5 criteria for moderate or severe ( > or = 4 criteria) alcohol use disorder
  3. 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
  4. No lifetime DSM-5 psychiatric disorders, including schizophrenia, schizoaffective disorder, bipolar disorder, or developmental disorders.
  5. No comorbid current DSM-5 depressive or anxiety disorders
  6. No other current DSM-5 substance use disorders, including opioids, cocaine, amphetamines, sedative-hypnotics, hallucinogens, and inhalants. Subjects with current moderate and severe DSM-5 cannabis use disorder will also be excluded
  7. Not currently on psychotropic medications that can directly (e.g., buprenorphine) or indirectly influence binding to NOP (e.g., medications that alter dopamine, GABA, glutamate, etc.) or modify alcohol consumption patterns (e.g., naltrexone, acamprosate, disulfiram);
  8. No regular use of medical medications that can potentially interact with hydrocortisone (other corticosteroids, mifepristone, etc.) or increase the risks associated with arterial line removal (warfarin, clopidogrel, aspirin, naproxen, ibuprofen, etc.)
  9. No clinically significant medical or neurological illnesses, including a history of immune compromise, HPA-axis dysfunction, Cushing's syndrome, glaucoma, morbid obesity, severe hyperglycemia, and hyperlipidemia, all of which are contraindications for hydrocortisone
  10. No history of anemia or history of deep vein thrombosis, pulmonary embolism, thrombocytopenia or thrombocytosis
  11. Not currently pregnant or breast-feeding
  12. No history of complicated alcohol withdrawal symptoms such as seizures, alcoholic hallucinosis, delirium tremens, or required admission to an inpatient detox program to prevent such symptoms
  13. Not currently employed as a radiation worker or has participated in a radiation-related research protocol within the previous year such that the total cumulative annual radiation dose (i.e., from participation in previous radioactive drug studies and this study) would exceed the radiation dose limits specified in the FDA regulations (i.e., 21 CFR 361.1) that govern the research use of radiotracers
  14. No metallic objects in the body that are contraindicated for MRI.

Healthy Control subjects (HC)

  1. Males or females between 18 and 55 years old
  2. No DSM-5 psychiatric or substance use disorders other than tobacco use disorder
  3. No NIAAA heavy drinking in the past year (> or = 5 drinks on any day or more than 14 drinks per week for males; > or = 4 drinks on any day or more than 7 drinks per week for females)
  4. 7 to 14 above.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rajesh Narendran contact

412-647-5176

narendranr@upmc.edu

United States1 site, 1 recruiting
  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

    Recruiting

Other trials in United States

About this study

Official title: Does a Hyperactive Nociceptin Opioid Peptide Receptor System Promote Relapse in Heavy Drinking AUD Subjects: a [C-11]NOP-1A and Hydrocortisone PET Study

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.

Read the detailed description

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.

Being tested
Baseline [C-11]NOP-1A PET scan, Hydrocortisone, Post-hydrocortisone [C-11]NOP-1A PET scan
Keywords
[C-11]NOP-1A PET, Nociceptive opioid peptide receptor
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Baseline [C-11]NOP-1A PET scanRadiation

    Radiotracer

  • HydrocortisoneDrug

    Intravenous, 1 mg/Kg

  • Post-hydrocortisone [C-11]NOP-1A PET scanRadiation

    Radiotracer

Study groups in NCT07612631
Study groupRoleWhat they receive
PETExperimental[C-11]NOP-1A
Receives: Radiation: Baseline [C-11]NOP-1A PET scan; Drug: Hydrocortisone; Radiation: Post-hydrocortisone [C-11]NOP-1A PET scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline/pre hydrocortisone, and 3-hours post hydrocortisone

  2. Total number of negative ETG tests

    Represents level of abstinence in contingency management

    Measured: over 8-week follow-up

Secondary outcomes (5)
  1. Midbrain DELTA VT

    VT is the volume of distribution expressed relative to total plasma radioligand

    Measured: Baseline/pre hydrocortisone and 3-hours post hydrocortisone

  2. Ventral striatum DELTA VT

    VT is the volume of distribution expressed relative to total plasma radioligand

    Measured: Baseline/pre hydrocortisone and 3-hours post hydrocortisone

  3. Orbitofrontal Cortex DELTA VT

    VT is the volume of distribution expressed relative to total plasma radioligand

    Measured: Baseline/pre hydrocortisone and 3-hours post hydrocortisone

  4. Relapse to alcohol

    Abstained; Relapsed; Drop-out

    Measured: over 8-weeks follow up

  5. Relapse to alcohol severity (self-reported)

    Heavy drinking days/week and Abstinent days/week

    Measured: over 8- week follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study start1 Jun 2026
  3. Primary completion30 Jun 2031 (estimated)
  4. Study completion30 Jun 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Alcohol use disorder and controls will receive the same intervention
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07612631
Sponsor's protocol ID
STUDY25050039
Other IDs
R01AA032487
Status last verified
Jun 2026
First submitted
16 May 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Baseline [C-11]NOP-1A PET scan, Hydrocortisone and Post-hydrocortisone [C-11]NOP-1A PET scan in people with Alcohol Use Disorder, run by Rajesh Narendran at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rajesh Narendran (412-647-5176, narendranr@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amygdala DELTA VT (time frame: Baseline/pre hydrocortisone, and 3-hours post hydrocortisone). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in