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Hydrocortisone-enhanced PET Scans for Cocaine Use Disorder

Phase < 1
Recruiting
Led By Rajesh Narendran, MD
Research Sponsored by Rajesh Narendran
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females between 18 and 55 years old
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, and 3 hours post-hydrocortisone
Awards & highlights

Study Summary

This trial uses a PET scan to look at how well opioids and cortisol work together in people with cocaine use disorders, compared to healthy controls. It also looks at whether changes in this interaction predict relapse in people with cocaine use disorders.

Who is the study for?
This trial is for men and women aged 18-55 with cocaine use disorder, without other psychiatric or addictive disorders. Participants must not be on medications, have severe illnesses, be pregnant/breastfeeding, have significant past radiation exposure, MRI-incompatible body metals, or recent abuse of various drugs including opiates and alcohol.Check my eligibility
What is being tested?
The study tests how cortisol interacts with brain receptors in people with cocaine addiction compared to healthy controls using PET scans before and after hydrocortisone administration. It aims to see if these interactions can predict relapse in cocaine users.See study design
What are the potential side effects?
Potential side effects from the hydrocortisone challenge may include temporary mood changes, increased blood sugar levels, insomnia, indigestion or an increase in appetite. The PET scan involves exposure to a small amount of radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, and 3 hours post-hydrocortisone
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and 3 hours post-hydrocortisone 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 VT

Trial Design

1Treatment groups
Experimental Treatment
Group I: PETExperimental Treatment3 Interventions
[C-11]NOP-1A
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrocortisone
2005
Completed Phase 4
~1260

Find a Location

Who is running the clinical trial?

Rajesh NarendranLead Sponsor
3 Previous Clinical Trials
95 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,469 Previous Clinical Trials
2,619,329 Total Patients Enrolled
Rajesh Narendran, MDPrincipal Investigator - University of Pittsburgh
University of Pittsburgh
1 Previous Clinical Trials
11 Total Patients Enrolled

Media Library

Hydrocortisone Clinical Trial Eligibility Overview. Trial Name: NCT05008146 — Phase < 1
Cocaine Use Disorder Research Study Groups: PET
Cocaine Use Disorder Clinical Trial 2023: Hydrocortisone Highlights & Side Effects. Trial Name: NCT05008146 — Phase < 1
Hydrocortisone 2023 Treatment Timeline for Medical Study. Trial Name: NCT05008146 — Phase < 1

Frequently Asked Questions

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

Have researchers conducted any prior trials pertaining to Hydrocortisone?

"At present, there are 60 active clinical trials researching Hydrocortisone across 3054 locations. Notably, 20 of these studies are in Phase 3 and many have a base of operations within New york City."

Answered by AI

Are there presently any openings for the clinical trial?

"Affirmative. Clinicaltrials.gov data confirms that this clinical study, initially posted on June 4th 2019, is actively seeking participants. Approximately 80 patients must be recruited from a single medical centre."

Answered by AI

What is the total number of volunteers involved in this clinical experiment?

"Affirmative. As per the details found on clinicaltrials.gov, this research is currently enrolling patients and was first posted on June 4th 2019. 80 individuals are required for participation across 1 trial site with the most recent update being made on June 27th 2022."

Answered by AI

For what conditions is Hydrocortisone commonly prescribed?

"Hydrocortisone is an efficacious treatment for ulcerative colitis, neoplastic malignancies, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Do I meet the criteria for participation in this investigation?

"This trial is seeking 80 individuals with a cocaine use disorder (CUD) aged between 18 and 55. To be eligible, participants must meet the DSM-5 criteria for CUD without any other current psychiatric or addictive diagnoses, not have abused opiates, sedative hypnotics, amphetamines etc in the last 6 months; have moderate to severe alcohol or cannabis use but no nicotine dependence according to the Fagerstrom Test; cannot currently be on medical/psychotropic medications nor pregnant/breastfeeding; do not have significant radioactivity exposure from another study that exceeds RDRC guidelines; and should not possess metallic objects which are contrain"

Answered by AI

Does the age limit for inclusion in this experiment extend beyond 60 years?

"The criteria for admission to this medical trial stipulates that all participants must be between 18 and 55 years of age."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Imaging CRF X NOP Interactions in CUD
Rajesh Narendran 2020. "Imaging CRF X NOP Interactions in CUD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05008146.
~45 spots leftby Sep 2028
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