Imaging dopamine release in cocaine use disorders using PET scans

[C-11]NPA PET-amphetamine in Cocaine Use Disorders (Aim 2)

This study is testing how dopamine levels change in the brains of people with cocaine use disorders when given a stimulant, to see if this can help find new ways to prevent relapse.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT05011760 on ClinicalTrials.gov

What this trial studies

This study employs [C-11]NPA positron emission tomography (PET) to visualize dopamine release in the striatum during a d-amphetamine challenge in individuals with cocaine use disorders. By correlating the dopamine release data with baseline measurements of nociceptive opioid peptide receptors, the study aims to uncover neurochemical abnormalities that contribute to relapse in cocaine addiction. The research focuses on understanding the balance between brain stress and resilience systems, which may lead to the development of new medications to prevent relapse in affected individuals.

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 psychiatric disorders, significant medical conditions, or those on certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatments that help prevent relapse in individuals with cocaine use disorders.

How similar studies have performed: Previous studies have indicated potential success in using neuroimaging to understand addiction mechanisms, but this specific approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

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, and MDMA 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
10. No baseline BP ≥ 140/90 and/or HR ≥ 100.
11. No first-degree relative with an MI or stroke prior to middle age
12. No first-degree relative with psychosis or mania.
13. Completed a baseline \[11C\]NOP-1A PET scan in Aim 1 (Study Record: Imaging CRF X NOP interactions in Cocaine Use Disorders)

Where this trial is running

Pittsburgh, Pennsylvania

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

Study contacts

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

Conditions Cocaine Use Disorder; [C-11]NOP-1A, [C-11]NPA , nociceptive opioid peptide receptors, dopamine release