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Neurosteroid
allopregnanolone for Alcoholism
Phase 1
Waitlist Available
Led By Elizabeth Ralevski, 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 30 minutes
Awards & highlights
Study Summary
This trial will test whether allopregnanolone can help heavy drinkers by reducing stress-induced cravings and anxiety.
Eligible Conditions
- Alcoholism
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Alcohol Urge Questionnaire (AUQ)
The State-Trait Anxiety Inventory (STAI-6)
Secondary outcome measures
Biphasic Alcohol Effects scale (BAES)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: allopregnanoloneActive Control1 Intervention
allopregnanolone
Group II: placeboPlacebo Group1 Intervention
placebo
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,863 Previous Clinical Trials
2,742,565 Total Patients Enrolled
84 Trials studying Alcoholism
10,363 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
811 Previous Clinical Trials
1,158,271 Total Patients Enrolled
428 Trials studying Alcoholism
778,341 Patients Enrolled for Alcoholism
Elizabeth Ralevski, PhDPrincipal InvestigatorYale University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have an addiction to any drugs except for tobacco, alcohol, and marijuana.You cannot participate if you are taking medications for alcoholism, sedatives, or antibiotics/antifungal medications. If you are taking psychotropic medication for a current psychiatric condition, you are also not eligible.You have a serious mental illness such as depression, schizophrenia, or severe anxiety disorder.You are not currently seeking treatment for alcohol use disorder (AUD) as defined by the DSM-5.
Research Study Groups:
This trial has the following groups:- Group 1: allopregnanolone
- Group 2: placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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