What side effects are associated with this type of intervention?

Common treatments for Cocaine Use Disorder (CUD) include behavioral therapies and medications that modulate neurotransmitter systems. While the specific study mentioned involves hydrocortisone to modulate cortisol levels, typical side effects of such treatments can include gastrointestinal issues, increased susceptibility to infections, and potential neuropsychiatric effects like mood swings or insomnia. Behavioral therapies, such as cognitive-behavioral therapy (CBT) and 12-step facilitation, generally have fewer physical side effects but may cause emotional distress as patients confront their addiction.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Cocaine Use Disorder (CUD). Research is ongoing to explore various pharmacological approaches, including those that modulate cortisol levels and interact with nociceptive opioid peptide (NOP) receptors, as studied in trials like the Hydrocortisone Challenge. These studies aim to understand the potential of such treatments in managing CUD, but no definitive approvals have been made yet.

What other types of research exist?

Promising novel alternatives to the Hydrocortisone Challenge for CUD patients include: 1) NOP receptor agonists or antagonists that directly target the nociceptive opioid peptide system, 2) CRF receptor antagonists that modulate the stress response, and 3) emerging therapies such as transcranial magnetic stimulation (TMS) and deep brain stimulation (DBS) which have shown potential in modulating brain circuits involved in addiction. These alternatives focus on directly influencing the neurobiological pathways implicated in CUD.

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Hydrocortisone-enhanced PET Scans for Cocaine Use Disorder

Q: What is the mechanism of action of this treatment?

Common treatments for Cocaine Use Disorder (CUD) often target the brain's reward and stress systems. One area of focus is the hypothalamo-pituitary-adrenal (HPA) axis, which regulates stress responses through cortisol release. Treatments like the hydrocortisone challenge aim to modulate cortisol levels to understand their interaction with nociceptive opioid peptide (NOP) receptors, which are involved in stress and addiction pathways. This is important for CUD patients as it helps identify potential therapeutic targets that can reduce cravings and prevent relapse by stabilizing stress responses. Other treatments may include behavioral therapies and medications that target dopamine and serotonin systems to reduce the rewarding effects of cocaine and support recovery.

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

Must not have

Not currently on prescription medical or psychotropic medications

No current or past severe medical, endocrine or neurological illnesses including glaucoma, seizure disorders, hypertension, hypercholesterolemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, and 3 hours post-hydrocortisone

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special brain scan and a stress hormone injection to study how brain receptors react in people with cocaine addiction. It aims to understand why these individuals often relapse by comparing them to healthy individuals.

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.

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.

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

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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any prescription drugs or mental health medications.

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I don't have severe illnesses like glaucoma, seizures, high blood pressure, or high cholesterol.

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I do not have any current psychiatric or addictive disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, and 3 hours post-hydrocortisone

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DELTA VT

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PETExperimental Treatment3 Interventions

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Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hydrocortisone

2005

Completed Phase 4

~1280

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cocaine Use Disorder (CUD) often target the brain's reward and stress systems. One area of focus is the hypothalamo-pituitary-adrenal (HPA) axis, which regulates stress responses through cortisol release. Treatments like the hydrocortisone challenge aim to modulate cortisol levels to understand their interaction with nociceptive opioid peptide (NOP) receptors, which are involved in stress and addiction pathways. This is important for CUD patients as it helps identify potential therapeutic targets that can reduce cravings and prevent relapse by stabilizing stress responses. Other treatments may include behavioral therapies and medications that target dopamine and serotonin systems to reduce the rewarding effects of cocaine and support recovery.

Interaction Between Stress and Addiction: Contributions From Latin-American Neuroscience.Preprodynorphin mediates locomotion and D2 dopamine and mu-opioid receptor changes induced by chronic 'binge' cocaine administration.Potential role for the hypothalamo-pituitary-adrenal axis in the conditioned reinforcer-induced reinstatement of extinguished cocaine seeking in rats.