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Not yet recruitingPhase 2

Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder

Targeting Neurosteroid Pathways in Alcohol Use Disorder: Clinical and Neural Impact of Pregnenolone Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks
  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be randomly assigned to receive either pregnenolone or placebo for 12 weeks in a double-blind study."
  • "The study will also use magnetic resonance imaging (MRI) to examine how pregnenolone affects brain circuits involved in addiction and mood regulation."
  • "Participants will be randomized to receive pregnenolone 500 mg/day (250 mg twice daily) or matched placebo for 12 weeks."
  • "Mechanistic objectives include examining the effects of pregnenolone on resting-state functional connectivity between the amygdala and prefrontal cortex and on brain responses to alcohol-related cues using functional magnetic resonance imaging (fMRI)."
  • "Clinical assessments will be conducted throughout the treatment period, and MRI scans will be obtained at baseline and Week 12."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This study will evaluate whether pregnenolone is an effective treatment for adults with Alcohol Use Disorder (AUD) and Major Depressive Disorder (MDD). Participants will be randomly assigned to receive either pregnenolone or placebo for 12 weeks in a double-blind study. Researchers will assess alcohol consumption, alcohol craving, depressive symptoms, and anxiety symptoms throughout treatment. The study will also use magnetic resonance imaging (MRI) to examine how pregnenolone affects brain circuits involved in addiction and mood regulation. The goal is to determine whether pregnenolone can improve both alcohol-related and mood-related outcomes and to identify the neural mechanisms associated with treatment response.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * Age 21 to 55 years. * Meets DSM-5 criteria for Alcohol Use Disorder (AUD). * Meets DSM-5 criteria for Major Depressive Disorder (MDD). * Able to provide informed consent. * Willing and able to comply with study procedures and assessments Exclusion Criteria: * Current diagnosis of bipolar disorder, schizophrenia spectrum disorder, or other psychotic disorder. * Current substance use disorder requiring immediate treatment other than alcohol or nicotine. * Significant unstable medical or neurologic illness that would interfere with participation or study assessments. * Contraindications to magnetic resonance imaging (MRI). * Current pregnancy or breastfeeding. * Current use of medications or treatments that would interfere with study participation or interpretation of results. * Significant suicide risk requiring a higher level of care. * Any condition that, in the investigator's judgment, would make participation unsafe or compromise study integrity.

Study sites (2)

TX