Effect of Allopregnanolone on Stress-induced Craving

Overseen By Ismene L Petrakis, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Yale University

Must not be taking: Alcoholism meds, Sedatives, Antibiotics, Antifungals

Disqualifiers: Psychiatric illnesses, Liver disease, Heart disease, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if a specific treatment can reduce stress and anxiety in heavy drinkers, potentially lowering their cravings for alcohol. The treatment has been shown to decrease alcohol consumption in animal studies.

Who Is on the Research Team?

Elizabeth Ralevski, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

Inclusion Criteria

No current medical problems and normal ECG

For women, not pregnant as determined by pregnancy screening, not breast feeding

You cannot have an addiction to any drugs except for tobacco, alcohol, and marijuana.

Exclusion Criteria

weight >120kg

renal impairment

History of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a continuous infusion of allopregnanolone or placebo for 175 minutes, followed by stress induction paradigm

1 day

1 visit (in-person)

Follow-up

Participants are monitored for stress-induced craving and anxiety, as well as mood effects, cognitive performance, and motor coordination

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Allopregnanolone

How Is the Trial Designed?

Group I: allopregnanolone Active Control 1 Intervention

allopregnanolone

Group II: placebo Placebo Group 1 Intervention

placebo

Allopregnanolone is already approved in United States for the following indications:

Approved in United States as Zulresso for:

• Postpartum depression

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+