NCT04464148

Feasibility Trial of Pregnenolone for Posttraumatic Stress Disorder and Alcohol Use Disorder

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Pregnenolone is a neurosteroid and an over-the-counter supplement that has shown promise in clinical studies of stress-related disorders, such as anxiety, depression and posttraumatic stress disorder (PTSD). Epidemiological studies suggest that patients with PTSD are at higher risk of developing addiction, including alcohol use disorder (AUD).The following hypothesis will be tested in this trial: pregnenolone is associated with a reduction in both PTSD symptoms and the number of standard drinks per week in outpatients with PTSD and AUD.

Detailed description

Investigators will conduct an 8-week, non-randomized, open label trial of pregnenolone in 20 persons with PTSD and AUD. The study will serve as a pilot study to determine feasibility and collect pilot data for NIH R01 proposals. All participants will be titrated to 800 mg/day of pregnenolone over the course of 4 weeks and maintain this dose for the remainder of the study. The study will consist of a screening visit to determine eligibility (Baseline I) and a Baseline II visit where participants will receive study medication, and follow-up visits at Weeks 1, 2, 3, 4, 6, and 8. Participants will complete a variety of assessments at each study visit, including clinician-rated and self-report measures of PTSD, alcohol use, depressive symptoms, cognitive performance, and side effects. Blood work will be done to ensure participant health and safety prior to randomization into the study, as well as to assess pregnenolone blood levels. All participants will meet with a study clinician at each visit to monitor safety and assess any adverse events.

Conditions

• Post Traumatic Stress Disorder
• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Pregnenolone 250 mg	Pregnenolone 250 mg capsule BID (500 mg QD total)
DRUG	Pregnenolone 400 mg	Pregnenolone 400 mg capsule BID (800 mg QD total)

Timeline

• Start date: 2021-12-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-07-09
• Last updated: 2021-08-23

Regulatory

• FDA-regulated drug study