Clinical trial NCT04464148: Feasibility Trial of Pregnenolone for Posttraumatic Stress Disorder and Alcohol Use Disorder
Official title: Feasibility Trial of Pregnenolone for Posttraumatic Stress Disorder and Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Post Traumatic Stress Disorder
Alcohol Use Disorder
Keywords: Pregnenolone
PTSD
Alcohol
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 (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.

Eligibility 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.

Primary outcomes:
measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Baseline to 8 weeks
measure: Standard alcoholic drinks per week
timeFrame: Baseline to 8 weeks
measure: Timeline Followback (TLFB) heavy drinking days
timeFrame: Baseline to 8 weeks
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE)
timeFrame: Baseline to 8 weeks
measure: Patient-rated PTSD Checklist for DSM-5 (PCL-5).
timeFrame: Baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UT Southwestern Medical Center
name: E. Sherwood Brown, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: