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

Summary

Participation Requirements

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 th...

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.

Tracking Information