Clinical trial

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

Name
STUDY20060171 (Aim 2)
Description
This study uses \[11C\]NPA positron emission tomography (PET) and a d-amphetamine challenge to image amphetamine induced dopamine release in the striatum in subjects with cocaine use disorders (CUD). Amphetamine-induced dopamine release data from this study will be correlated with \[11C\]NOP-1A VT measured at baseline in the midbrain. \[11C\]NOP-1A PET data will be used from aim 1 (see, Study Record: Imaging CRF X NOP interactions in Cocaine Use Disorders)
Trial arms
Trial start
2021-01-31
Estimated PCD
2028-09-01
Trial end
2028-09-01
Status
Recruiting
Phase
Early phase I
Treatment
Baseline [C-11]NPA PET Scan
Radiotracer
Arms:
PET
d-amphetamine
Oral, 0.5 mg/Kg
Arms:
PET
Post-amphetamine [C-11]NPA PET Scan
Radiotracer
Arms:
PET
Size
30
Primary endpoint
DELTA binding potential relative to non displaceable uptake (BPND)
Baseline, and 2.5 to 3 hours post-amphetamine
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group, correlational analyses', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-05-06

1 organization

1 product

1 indication

Organization
Rajesh Narendran