NCT05781009 Pregnenolone for the Treatment of Alcohol Use Disorder
| NCT ID | NCT05781009 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Yale University |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2024-01-08 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This Phase 2 randomized cotrolled trial (RCT) will assess the safety and efficacy of pregnenolone (PREG; 300 mg/day, b.i.d dosing) vs. placebo (PBO) over a 12 week treatment period, and at 1-month post-treatment follow-up in individuals with Alcohol Use Disorder (AUD).
Eligibility Criteria
Inclusion Criteria: * Male and females, aged 18-70 years; * Regular weekly use of alcohol at least 3X weekly or more at treatment entry; * Must meet current DSM-5 criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-5; * No health conditions that would impact trial participation as verified by screening and physical examination and absence of any of the exclusion criterions outlined below; * Able to read English and complete study evaluations; * Able to provide informed written and verbal consent. Exclusion Criteria: * Meet current criteria for moderate to severe substance use disorders from use of any other psychoactive substance, excluding nicotine and cannabis use disorder; * Current use of opioids; * Regular use of anticonvulsants, sedatives or hypnotics, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), topiramate, baclofen; * Regular use of steroidal supplements and steroid medications interacting with study medications based on clinical judgement of study physician (excluding hormonal contraceptives in women); * Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania); * Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study, but stable, prescribed anti-hypertensives. cardiovascular and diabetes medications will be allowed after review by study physician; * Any psychotic disorder or current Axis I psychiatric disorders requiring specific acute attention, including need for psychiatric medications, but stable, prescribed antidepressants and anti-anxiety medication to treat co-occurring psychiatric disorders will be allowed; * Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by urine pregnancy tests during initial medical evaluation, and assessed every two weeks during the course of the study).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05781009 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05781009 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05781009 currently recruiting?
Yes, NCT05781009 is actively recruiting participants. Contact the research team at verica.milivojevic@yale.edu for enrollment information.
Where is the NCT05781009 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT05781009 clinical trial?
NCT05781009 is sponsored by Yale University. The trial plans to enroll 150 participants.