Status:
RECRUITING
[C-11]NPA PET-amphetamine in Cocaine Use Disorders
Lead Sponsor:
Rajesh Narendran
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Use Disorder
Eligibility:
All Genders
18-55 years
Phase:
EARLY_PHASE1
Brief Summary
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). ...
Detailed Description
Cocaine use disorder (CUD) is a chronic disorder associated with numerous relapses and periods of abstinence. Studies in CUD suggest that \~ 60 to 75% of abstinent addicts relapse over twelve months....
Eligibility Criteria
Inclusion Criteria:
- Males or females between 18 and 55 years old
- Fulfil DSM-5 criteria for cocaine use disorder
- No other current DSM-5 psychiatric or addictive disorders (such as major depressive disorder, bipolar disorders, psychotic disorders, etc.,)
- 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);
- Not currently on prescription medical or psychotropic medications
- 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
- Not currently pregnant or breastfeeding
- No history of significant radioactivity exposure in past year from another research study or occupation that exceeds RDRC guidelines
- No metallic objects in the body that are contraindicated for MRI
- No baseline BP ≥ 140/90 and/or HR ≥ 100.
- No first-degree relative with an MI or stroke prior to middle age
- No first-degree relative with psychosis or mania.
- Completed a baseline [11C]NOP-1A PET scan in Aim 1 (Study Record: Imaging CRF X NOP interactions in Cocaine Use Disorders)
Key Trial Info
Start Date :
January 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05011760
Start Date
January 31 2021
End Date
September 1 2028
Last Update
June 5 2025
Active Locations (1)
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1
University of PIttsburgh
Pittsburgh, Pennsylvania, United States, 15213