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

STUDY20060171 (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.

2020-12-31

2028-09-01

2028-09-01

Recruiting

Early phase I

80

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Cocaine Use disorder and Healthy control groups will receive same interventions', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

2024-05-06