Allopregnanolone for Alcoholism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether allopregnanolone (also known as Brexanolone or Zulresso) can reduce cravings and anxiety triggered by stress, particularly in heavy drinkers. The study will test the effects of allopregnanolone through an infusion and compare it to a placebo, which contains no active drug. Ideal participants are those with an alcohol use disorder who are not currently seeking treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
You may need to stop taking certain medications to join this trial. Specifically, you cannot be on medications for alcoholism, sedating psychotropic medications, or antibiotics/antifungals.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that allopregnanolone, similar to the drug brexanolone, has undergone safety testing. The FDA has approved brexanolone for treating postpartum depression. In studies, some participants experienced side effects such as drowsiness, dry mouth, or fainting. However, these side effects were uncommon. Thus, while some risks exist, many individuals tolerate the treatment well.12345
Why do researchers think this study treatment might be promising?
Most treatments for stress-induced cravings focus on behavioral therapy or medications that alter neurotransmitter activity, like SSRIs. But allopregnanolone works differently, targeting the brain's response to stress by acting on GABA receptors, which are crucial for calming neural activity. Researchers are excited about allopregnanolone because it’s a naturally occurring neurosteroid that may offer a more direct way to reduce cravings triggered by stress, potentially leading to faster and more effective relief compared to current options. Additionally, the infusion delivery method allows precise control over dosing, which could enhance its effectiveness and reduce side effects.
What evidence suggests that allopregnanolone might be an effective treatment for stress-induced craving and anxiety?
Research has shown that allopregnanolone, a compound similar to brexanolone, might help reduce cravings and anxiety caused by stress. Allopregnanolone influences certain parts of the brain that control mood. In this trial, participants will receive either an allopregnanolone infusion or a placebo. Brexanolone, a similar drug, successfully treated postpartum depression by greatly reducing symptoms. In clinical trials, brexanolone outperformed a placebo, suggesting that allopregnanolone might also be effective. These findings offer hope that allopregnanolone could help manage stress-related cravings and anxiety.56789
Who Is on the Research Team?
Elizabeth Ralevski, PhD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a continuous infusion of allopregnanolone or placebo for 175 minutes, followed by stress induction paradigm
Follow-up
Participants are monitored for stress-induced craving and anxiety, as well as mood effects, cognitive performance, and motor coordination
What Are the Treatments Tested in This Trial?
Interventions
- Allopregnanolone
Allopregnanolone is already approved in United States for the following indications:
- Postpartum depression
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator