NCT05008146 Imaging CRF X NOP Interactions in CUD
| NCT ID | NCT05008146 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Rajesh Narendran |
| Condition | Cocaine Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2020-12-31 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2020-12-31 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). It will also examine whether alterations in CRF x NOP interactions predict relapse in subjects with CUD.
Eligibility Criteria
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.
Contact & Investigator
Rajesh Narendran, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05008146 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Cocaine Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05008146 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05008146 currently recruiting?
Yes, NCT05008146 is actively recruiting participants. Contact the research team at narendranr@upmc.edu for enrollment information.
Where is the NCT05008146 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT05008146 clinical trial?
NCT05008146 is sponsored by Rajesh Narendran. The principal investigator is Rajesh Narendran, MD at University of Pittsburgh. The trial plans to enroll 80 participants.