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

• Status: Withdrawn
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center

Criteria

Inclusion Criteria:

• Outpatient adults (males and females) 18-70 years of age

• Meet criteria for current PTSD based on SCID-CV for DSM 5.

• Meet criteria for current AUD based on SCID-CV for DSM 5.

• Alcohol use of 14 standard drinks per week for men and 7 for women based on TLFB in the last week.

• Able to read and speak in English.

• If taking psychotropic medications, taking a stable dose for the past 2 weeks and during the study treatment.

Exclusion Criteria:

• Vulnerable populations (e.g., pregnancy/nursing, severe cognitive impairment, incarcerated).

• Current DSM-5 diagnosis of bipolar disorder, schizophrenia or other psychotic disorders based on SCID-CV.

• High risk for suicide (active SI with plan/intent or > 3 lifetime attempts in lifetime or any in the past 3 months).

• Coronary artery disease, atrial fibrillation, stroke, deep vein thrombosis, pulmonary embolism or blood clotting disorder, uncontrolled hypertension, cirrhosis or any severe, life threatening or unstable, medical condition as determined by clinician assessment.

• Clinically significant laboratory or physical examination findings.

• AST or ALT > 3 times the upper limit of normal.

• Evidence of clinically significant alcohol withdrawal symptoms defined as a CIWA-Ar score of ≥ 10.

• Current (last 14 days) treatment with naltrexone, acamprosate, disulfiram, topiramate.

• Intensive outpatient treatment (defined as ≥ 3 visits each week) for substance abuse (AA, NA meetings, or less intensive counseling at baseline will be allowed) or intensive psychosocial treatment for PTSD.

• Hormone-sensitive conditions (i.e. breast cancer; uterine/ovarian cancer, endometriosis, uterine fibroids).

• Use of oral contraceptives or hormone replacement therapy.

• History of allergic reaction or side effects with prior pregnenolone use.