Imaging interactions between stress hormones and opioid receptors in cocaine use disorder

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

This study is testing how stress hormones and certain brain receptors interact in people with cocaine use disorder to see if these interactions can help predict relapse.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT05008146 on ClinicalTrials.gov

What this trial studies

This study utilizes [C-11]NOP-1A positron emission tomography (PET) to investigate the interactions between nociceptive opioid peptide (NOP) receptors and cortisol/corticotrophin releasing factor (CRF) in individuals with cocaine use disorder (CUD) and healthy controls. It aims to understand how these interactions may predict relapse in CUD patients by examining neurochemical changes associated with stress and resilience. Participants will undergo baseline and post-hydrocortisone PET scans to assess NOP receptor binding and its response to stress. The findings could provide insights into the neurobiological mechanisms underlying relapse in CUD.

Who should consider this trial

Good fit: Ideal candidates for this study are males and females aged 18 to 55 who meet DSM-5 criteria for cocaine use disorder without other psychiatric or addictive disorders.

Not a fit: Patients with current or past severe medical, endocrine, or neurological illnesses, or those with other significant psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the development of targeted medications to prevent relapse in individuals with cocaine use disorder.

How similar studies have performed: While studies have explored neurochemical mechanisms in addiction, this specific approach using NOP receptor imaging in CUD is relatively novel and has not been extensively tested.

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.

Where this trial is running

Pittsburgh, Pennsylvania

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Rajesh Narendran, MD — University of Pittsburgh
• Study coordinator: Rajesh Narendran, MD

Conditions Cocaine Use Disorder; Cocaine use disorder; [C-11]NOP-1A PET; Nociceptive opioid peptide receptors