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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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)
- 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.
- No comorbid current DSM-5 depressive or anxiety disorders
- 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
- 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);
- 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.)
- 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
- No history of anemia or history of deep vein thrombosis, pulmonary embolism, thrombocytopenia or thrombocytosis
- Not currently pregnant or breast-feeding
- 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
- 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
- No metallic objects in the body that are contraindicated for MRI.
Healthy Control subjects (HC)
- Males or females between 18 and 55 years old
- No DSM-5 psychiatric or substance use disorders other than tobacco use disorder
- 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)
- 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.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
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.
- Conditions
- Alcohol Use Disorder
- 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 group | Role | What they receive |
|---|---|---|
| PET | Experimental | [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.
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
Total number of negative ETG tests
Represents level of abstinence in contingency management
Measured: over 8-week follow-up
Secondary outcomes (5)
Midbrain DELTA VT
VT is the volume of distribution expressed relative to total plasma radioligand
Measured: Baseline/pre hydrocortisone and 3-hours post hydrocortisone
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
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
Relapse to alcohol
Abstained; Relapsed; Drop-out
Measured: over 8-weeks follow up
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.
- First posted29 May 2026
- Study start1 Jun 2026
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Rajesh Narendran
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Rajesh Narendran, University of Pittsburgh
- Investigators
- Rajesh Narendran, Principal investigator, University of Pittsburgh
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07612631
- Acronym / sponsor ID
- STUDY25050039
- Conditions
- Alcohol Use Disorder
- Keywords
- [C-11]NOP-1A PET, Nociceptive opioid peptide receptor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Rajesh NarendranUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Alcohol use disorder and controls will receive the same intervention
| Arm | Type | Receives |
|---|---|---|
| PET | Experimental | Radiation: Baseline [C-11]NOP-1A PET scan, Drug: Hydrocortisone, Radiation: Post-hydrocortisone [C-11]NOP-1A PET scan[C-11]NOP-1A |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline [C-11]NOP-1A PET scanRadiotracer | Radiation | PET |
| HydrocortisoneIntravenous, 1 mg/Kg | Drug | PET |
| Post-hydrocortisone [C-11]NOP-1A PET scanRadiotracer | Radiation | PET |
Primary outcome
Amygdala DELTA VT
Time frame: Baseline/pre hydrocortisone, and 3-hours post hydrocortisone
VT is the volume of distribution expressed relative to total plasma radioligand concentration; DELTA VT is the change from baseline to post-hydrocortisone
Total number of negative ETG tests
Time frame: over 8-week follow-up
Represents level of abstinence in contingency management
5 secondary outcomes
Midbrain DELTA VT
Time frame: Baseline/pre hydrocortisone and 3-hours post hydrocortisone
Ventral striatum DELTA VT
Time frame: Baseline/pre hydrocortisone and 3-hours post hydrocortisone
Orbitofrontal Cortex DELTA VT
Time frame: Baseline/pre hydrocortisone and 3-hours post hydrocortisone
Relapse to alcohol
Time frame: over 8-weeks follow up
Relapse to alcohol severity (self-reported)
Time frame: over 8- week follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajesh Narendran principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
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.