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[C-11]NPA PET-Amphetamine for Cocaine Use Disorder

Phase < 1
Recruiting
Research Sponsored by Rajesh Narendran
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No first-degree relative with an MI or stroke prior to middle age
Not currently on prescription medical or psychotropic medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, and 2.5 to 3 hours post-amphetamine
Awards & highlights

Study Summary

This trial uses PET scans and amphetamines to study how dopamine is released in the brains of people with cocaine use disorders, in hopes of better understanding the disorder.

Who is the study for?
This trial is for men and women aged 18-55 with a diagnosis of cocaine use disorder. Participants must not be on medications, have high blood pressure or heart rate, or be pregnant/breastfeeding. They should not have major psychiatric disorders, severe medical conditions, or a family history of early heart attacks/strokes/psychosis. No heavy recent use of other drugs/alcohol and must have completed a related PET scan in another study.Check my eligibility
What is being tested?
The study tests how d-amphetamine affects dopamine release in the brain using [C-11]NPA PET scans before and after administering d-amphetamine to individuals with cocaine use disorders. It aims to link these effects to previous midbrain imaging results from an earlier phase of the research.See study design
What are the potential side effects?
Potential side effects may include changes in blood pressure and heart rate due to d-amphetamine, as well as possible discomfort from the PET scanning procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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None of my immediate family had a heart attack or stroke before middle age.
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I am not taking any prescription drugs or mental health medications.
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None of my immediate family has had psychosis or mania.
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I don't have severe illnesses like glaucoma, seizures, high blood pressure, or high cholesterol.
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I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, and 2.5 to 3 hours post-amphetamine
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and 2.5 to 3 hours post-amphetamine for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DELTA binding potential relative to non displaceable uptake (BPND)

Trial Design

1Treatment groups
Experimental Treatment
Group I: PETExperimental Treatment3 Interventions
[C-11]NPA PET Scan
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
d-amphetamine
2018
Completed Early Phase 1
~50

Find a Location

Who is running the clinical trial?

Rajesh NarendranLead Sponsor
3 Previous Clinical Trials
145 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,469 Previous Clinical Trials
2,619,379 Total Patients Enrolled

Media Library

Baseline [C-11]NPA PET Scan Clinical Trial Eligibility Overview. Trial Name: NCT05011760 — Phase < 1
Cocaine Use Disorder Research Study Groups: PET
Cocaine Use Disorder Clinical Trial 2023: Baseline [C-11]NPA PET Scan Highlights & Side Effects. Trial Name: NCT05011760 — Phase < 1
Baseline [C-11]NPA PET Scan 2023 Treatment Timeline for Medical Study. Trial Name: NCT05011760 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining for this experiment?

"Correct. Information hosted on clinicaltrials.gov verifies that this medical experiment is actively searching for volunteers; it was first posted on September 13th 2021, and the most recent data update occurred on June 27th 2022. This trial is aiming to recruit 30 participants from a single location."

Answered by AI

Does this research include participants who are over 35 years of age?

"Applicants aged 18 to 55 may be eligible for this trial; if not, there are 249 additional trials available specifically targeting minors and 625 dedicated to those over retirement age."

Answered by AI

Could I be a participant in this medical experiment?

"This clinical research is enrolling 30 individuals aged 18 to 55 who experience cocaine use disorder. Eligibility criteria additionally demand that participants are not on current psychotropic or medical prescription medications, nor pregnant/breastfeeding; have no history of radiation exposure beyond what the RDRC permits in a year; demonstrate baseline BP and HR levels below 140/90 and 100 respectively; lack any other DSM-5 psychiatric diagnosis including major depressive disorder and bipolar disorders; show no indication of severe endocrine, neurological, or general illnesses such as glaucoma, seizure disorders, hypertension, hypercholesterolemia (as verified through physical examination)."

Answered by AI

Are there any other research projects that have centered around d-amphetamine?

"Presently, 8 clinical trials have been instigated for d-amphetamine. One trial is currently in its third and final phase of testing while the other seven are at early stages. These studies span 11 different locations with a primary focus on Atlanta, Georgia."

Answered by AI
~17 spots leftby Sep 2028