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Cocaine Use DisorderEarly Phase 1NCT05008146

Imaging CRF X NOP Interactions in CUD

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 Cocaine 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
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Cocaine 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
80 participants
Where
1 siteUnited States
Study dates
31 Dec 2020to 1 Sep 2028
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

Cocaine use disorders (CUD)

  1. Males or females between 18 and 55 years old
  2. Fulfil DSM-5 criteria for cocaine use disorder
  3. No other current DSM-5 psychiatric or addictive disorders (such as major depressive disorder, bipolar disorders, psychotic disorders, etc.,)
  4. 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);
  5. Not currently on prescription medical or psychotropic medications
  6. No current or past severe medical, endocrine or neurological illnesses including glaucoma, seizure disorders, hypertension, hypercholesterolemia as assessed by a complete medical history and physical
  7. Not currently pregnant or breastfeeding
  8. No history of significant radioactivity exposure in past year from another research study or occupation that exceeds RDRC guidelines
  9. No metallic objects in the body that are contraindicated for MRI

Healthy Controls (HC)

  1. Males or females between 18 and 55 years old
  2. No present or past DSM-5 disorders (other than nicotine dependence)
  3. Criteria 5 to 9 as listed previously.

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, MD contact

4126475176

narendranr@upmc.edu

United States1 site, 1 recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

    Rajesh Narendran, 4126475176, narendranr@upmc.edu

    Recruiting

Other trials in United States

About this study

Official title: Imaging Corticotrophin-releasing Factor (CRF) X Nociceptive Opioid Peptide (NOP) Interactions in Cocaine Use Disorders (Aim 1)

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.

Read the detailed description

Cocaine use disorder (CUD) is a chronic disorder associated with numerous relapses and periods of abstinence.

Studies in CUD suggest that ~ 60 to 75% of abstinent addicts relapse over twelve months Documenting specific neurochemical abnormalities that lead to relapse in individuals with CUD has the potential to accelerate the development of medications to prevent relapse. Basic investigations postulate an imbalance between brain stress and anti-stress/resilience systems as the underlying mechanism that drives negative reinforcement, craving, and relapse in addiction. Nociceptin (N/OFQ), which binds to the nociceptive opioid peptide receptors (NOP) is a critical component of the brain's anti-stress system. N/OFQ counteracts the functional effects of the primary stress-promoting neuropeptide corticotrophin releasing factor (CRF) in the brain to exert its anti-stress effects. Studies have also shown that acute increases in CRF and stress are countered by increased NOP receptor expression (~ 10% ) in brain regions that regulate stress such as bed nucleus of the stria terminalis. PET studies with the NOP radiotracer [11C]NOP-1A show increased binding to NOP in CUD compared to HC. PET studies also show NOP receptors to upregulate (~ 15%) in response to an acute intravenous hydrocortisone challenge (1 mg/Kg). NOP upregulation may represent an adaptive mechanism in the brain to counteract stress-induced increases in cortisol and CRF. Here, we postulate a failure in this adaptive mechanism as a reason that leads to relapse in CUD. CUD subjects and HC will be studied with [11C]NOP-1A before and after an intravenous hydrocortisone challenge (aim 1). Hydrocortisone is used as a challenge because it increases cortisol and CRF in brain regions that regulate stress. We hypothesize that hydrocortisone-induced increases in [11C]NOP-1A binding (DELTA VT) will be smaller in CUD relative to HC, and this will be associated with less time to relapse in a 12-week follow up.

Being tested
Baseline [C-11]NOP-1A PET Scan, Hydrocortisone, Post-hydrocortisone [C-11]NOP-1A PET Scan
Keywords
Cocaine use disorder, [C-11]NOP-1A PET, Nociceptive opioid peptide receptors

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, 1mg/Kg

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

    Radiotracer

Study groups in NCT05008146
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. 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.

    Measured: Baseline, and 3 hours post-hydrocortisone

Timeline

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

  1. First posted17 Aug 2021
  2. Study start31 Dec 2020
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2028 (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
Cocaine Use disorder and Healthy control groups will receive same interventions
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05008146
Sponsor's protocol ID
STUDY20060171 (Aim 1)
Other IDs
R01DA026472, STUDY19110156
Status last verified
Jul 2026
First submitted
11 Aug 2021
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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 Cocaine 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 6 Jul 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, MD (4126475176, narendranr@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DELTA VT (time frame: Baseline, and 3 hours post-hydrocortisone). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05008146.

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 6 Jul 2026.

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