Status:
WITHDRAWN
Feasibility Trial of Pregnenolone for Posttraumatic Stress Disorder and Alcohol Use Disorder
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Post Traumatic Stress Disorder
Alcohol Use Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04464148
Start Date
December 1 2021
End Date
December 1 2021
Last Update
August 23 2021
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