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Search / Trial NCT05011760

[C-11]NPA PET-amphetamine in Cocaine Use Disorders

Launched by RAJESH NARENDRAN · Aug 13, 2021

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

[C 11]Nop 1 A, [C 11]Npa , Nociceptive Opioid Peptide Receptors, Dopamine Release

ClinConnect Summary

This clinical trial, titled "[C-11]NPA PET-amphetamine in Cocaine Use Disorders," is researching how the brain responds to a substance called amphetamine in individuals who have cocaine use disorder (CUD). The study uses a special imaging technique called PET (positron emission tomography) to look at changes in dopamine, a chemical in the brain linked to feelings of pleasure and reward, when participants take amphetamine. By understanding these changes, researchers hope to gain insights into how cocaine affects the brain.

To be eligible for the trial, participants must be between 18 and 55 years old and meet specific criteria for cocaine use disorder. They should not have other major mental health or addiction issues and must not be using certain substances like opiates or alcohol. Participants will undergo a baseline PET scan and then take part in the study to see how their brain reacts. It’s important to note that individuals with certain health conditions, like severe medical illnesses or high blood pressure, will not be eligible. This study is currently recruiting participants, and those who take part will contribute to valuable research that may improve understanding and treatment of cocaine use disorder.

Gender

ALL

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)

About Rajesh Narendran

Rajesh Narendran is a dedicated clinical trial sponsor with extensive experience in managing and overseeing clinical research initiatives. With a strong emphasis on advancing medical knowledge and improving patient outcomes, Rajesh is committed to ensuring the highest standards of compliance, safety, and ethical practices in all trial phases. His collaborative approach fosters partnerships with leading research institutions and healthcare professionals, enabling innovative solutions and robust data collection. Through strategic planning and meticulous execution, he aims to drive successful clinical trials that contribute to the development of effective therapies and improve healthcare delivery.

Locations

Pittsburgh, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Rajesh Narendran

Principal Investigator

University of Pittsburgh

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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