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:

  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)

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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Page 1 of 1 (1 locations)

1

University of PIttsburgh

Pittsburgh, Pennsylvania, United States, 15213