What is the mechanism of action of this treatment?

Common treatments for Cocaine Use Disorder (CUD) often focus on modulating neurotransmitter systems disrupted by cocaine use. Neuroactive steroids like pregnenolone work by influencing neurotransmitter receptors and ion channels, which can help manage stress, reduce drug cravings, and mitigate drug-seeking behaviors. This is crucial for CUD patients as it addresses the underlying neurochemical imbalances caused by cocaine, potentially improving treatment adherence and reducing relapse rates. Combination therapies targeting multiple neurotransmitter systems are also being explored to enhance treatment efficacy.

What side effects are associated with this type of intervention?

Common treatments for Cocaine Use Disorder include behavioral therapies, medications like disulfiram, and neuroactive steroid modulation such as Pregnenolone. Behavioral therapies generally have minimal side effects but can include emotional distress as patients confront their addiction. Disulfiram can cause side effects like liver toxicity, drowsiness, and a metallic taste. Neuroactive steroids like Pregnenolone are being studied for their potential benefits, but known side effects may include hormonal imbalances, mood swings, and gastrointestinal issues. Overall, side effects vary depending on the specific treatment modality used.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Cocaine Use Disorder. Research is ongoing into various potential treatments, including neuroactive steroids like pregnenolone, which are being studied for their role in modulating stress and drug craving. These studies aim to explore new therapeutic avenues given the current lack of approved pharmacological options.

What other types of research exist?

Promising novel alternatives to Pregnenolone for treating Cocaine Use Disorder in 2024 include: 1) N-acetylcysteine (NAC), which has shown potential in reducing cocaine cravings and relapse; 2) Baclofen, a GABA-B receptor agonist that may help reduce cocaine use; 3) Varenicline, typically used for smoking cessation, which has shown some efficacy in reducing cocaine use; and 4) Deep brain stimulation (DBS), an emerging neuromodulation technique that has shown promise in severe cases of addiction.

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Pregnenolone for Cocaine Use Disorder

Phase < 1

Waitlist Available

Led By Verica Milivojevic, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between weeks 2-3 of treatment

Summary

This trial is testing a hormone pill called pregnenolone in people addicted to cocaine. It aims to see if the pill can reduce cravings, improve mood, and help manage stress better.

Who is the study for?

This trial is for men and women aged 18-60 with a cocaine use disorder, confirmed by a positive urine test or reports from close contacts. Participants must be able to read English and give informed consent. It excludes those using opiates or certain psychoactive drugs, with psychotic disorders, significant medical conditions, pregnant/nursing women, or those not on birth control.

What is being tested?

The study tests the effects of pregnenolone (PREG), at doses of 300mg and 500mg daily, against a placebo in individuals with cocaine use disorder. The goal is to understand how neuroactive steroids affect stress and drug cravings/usage in these individuals.

What are the potential side effects?

While specific side effects are not listed for PREG in this context, common reactions may include headache, fatigue, irritability or other mood changes. As it's an investigational study, part of its purpose is to monitor any potential side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between weeks 2-3 of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between weeks 2-3 of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and between weeks 2-3 of treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Craving Change in Stress and Cue Relative to Neutral

Secondary study objectives

Anxiety Change in Stress and Cue Relative to Neutral

Cortisol Level Change in Stress and Cue Relative to Neutral

Pregnenolone Concentration

Other study objectives

Cocaine Dollar Amount During Trial Period

Mean Percent Cocaine Days

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: PREG 500Experimental Treatment1 Intervention

Eligible participants will be randomly assigned to PREG 500 mg/day over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.

Group II: PREG 300Experimental Treatment1 Intervention

Eligible participants will be randomly assigned to PREG 300 mg/day over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.

Group III: patients receiving placeboPlacebo Group1 Intervention

Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pregnenolone (PREG)

2019

Completed Early Phase 1

~60

Do I qualify?Apply below to find out

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 focus on modulating neurotransmitter systems disrupted by cocaine use. Neuroactive steroids like pregnenolone work by influencing neurotransmitter receptors and ion channels, which can help manage stress, reduce drug cravings, and mitigate drug-seeking behaviors. This is crucial for CUD patients as it addresses the underlying neurochemical imbalances caused by cocaine, potentially improving treatment adherence and reducing relapse rates. Combination therapies targeting multiple neurotransmitter systems are also being explored to enhance treatment efficacy.

Increased functional connectivity in gambling disorder correlates with behavioural and emotional dysregulation: Evidence of a role for the cerebellum.Pharmacotherapeutics for substance-use disorders: a focus on dopaminergic medications.