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Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder

ConditionsAlcohol Use Disorder (AUD)Major Depressive Disorder (MDD)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-55
SponsorSherwood Brown, MD, PhD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pregnenolone

    Drug

    Pregnenolone 500 mg/day administered as 250 mg twice daily for 12 weeks.

  • Placebo

    Drug

    Matching placebo capsules administered twice daily for 12 weeks.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: PregnenoloneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Alcohol Consumption

Change in alcohol consumption from baseline to Week 12. The timeline follow-back (TLFB) is a semi-structured interview method assessing recent drinking in which participants retrospectively estimate daily quantity of alcohol consumption during specified time periods. The TLFB will be used to assess alcohol use including drinks/drinking day and drinks/day (7-day average).

Time frame
Baseline to Week 12

Secondary outcomes

1

Alcohol Craving

Change in alcohol craving severity from baseline to Week 12. The PACS is a 5-item, self-report measure that includes questions about the frequency, intensity and duration of alcohol craving in the previous week. PACS will be used to measure alcohol craving.

Time frame
Baseline to Week 12
2

Depressive Symptom Severity

Change in depressive symptom severity from baseline to Week 12. The Quick Inventory of Depressive Symptomatology Clinician version (QIDS-C) is a 16-item observer-rated scale assessing depressive symptom severity. The QIDS-C will be used to measure changes in depressive symptom severity.

Time frame
Baseline to Week 12
3

Anxiety Symptom Severity

Change in anxiety symptom severity from baseline to Week 12. The Hamilton Anxiety Rating Scale (HAM-A) is a 14-item, observer-rated scale assessing anxiety symptom severity. The HAM-A will be used to measure changes in anxiety symptom severity.

Time frame
Baseline to Week 12
4

Amygdala-Prefrontal Functional Connectivity

Change in resting-state functional connectivity between the amygdala and prefrontal cortex. Resting-state functional connectivity (rsFC) will be measured. Each participant's average connectivity between prefrontal cortex and amygdala regions of interest (ROIs) will be calculated by averaging the Fisher's Z-transformed pairwise correlation coefficients among the selected ROI pairs.

Time frame
Baseline and Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sherwood Brown, MD, PhD

Lead sponsor

University of Texas Southwestern Medical Center

Sponsor institution

The University of Texas at Dallas

Collaborator

Duke University

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: