- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04464148
Feasibility Trial of Pregnenolone for Posttraumatic Stress Disorder and Alcohol Use Disorder
August 19, 2021 updated by: Sherwood Brown, MD, PhD, University of Texas Southwestern Medical Center
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pregnenolone 250 BID > Pregnenolone 400 BID
For week 0-5 participants will receive pregnenolone 250 mg twice a day (total 500 mg/day).
For weeks 6-8 participants will receive 400 mg twice a day (800 mg/day), if the drug is well tolerated.
|
Pregnenolone 250 mg capsule BID (500 mg QD total)
Pregnenolone 400 mg capsule BID (800 mg QD total)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time Frame: Baseline to 8 weeks
|
CAPS-5 is a 30-item questionnaire, corresponding to the DSM-5 diagnosis for PTSD.
CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms.
Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20).
A symptom cluster score may also be calculated for dissociation by summing items 19 and 20.
The higher scores are associated with greater PTSD severity.
|
Baseline to 8 weeks
|
Standard alcoholic drinks per week
Time Frame: Baseline to 8 weeks
|
The Timeline Followback will be used to assess the change in the number of standard alcoholic drinks per week.
The TLFB will be administered by an interviewer and involves asking participants to retrospectively estimate their alcohol use 28 days prior to the first appointment and between each visit.
The reported drinks are then converted to standard drinks based on the drink's alcohol by volume (ABV).
The higher number is associated with more standard drinks and worse outcome.
|
Baseline to 8 weeks
|
Timeline Followback (TLFB) heavy drinking days
Time Frame: Baseline to 8 weeks
|
The Timeline Followback will be used to assess the change in the number of standard alcoholic drinks per week.
The TLFB will be administered by an interviewer and involves asking participants to retrospectively estimate their alcohol use 28 days prior to the first appointment and between each visit.
The reported drinks are then converted to heavy drinking days based on the drink's alcohol by volume (ABV) and participant's sex (male/female) - 5 drinks per day for males and 4 for females.
Each day during which 4-5 drinks are consumed is counted as a heavy drinking day within a given assessment period.
The higher number is associated with more heavy drinking days and worse outcome.
|
Baseline to 8 weeks
|
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Time Frame: Baseline to 8 weeks
|
SAFTEE is a side effect self-report assessment scale that consists of 56 potential side effects.
Participants rate how bothersome each side effect is on a scale of "none" (0), "mild" (1), "moderate" (2), "severe" (3).
The higher total score (all items summed together) indicates a higher level of side effect burden.
|
Baseline to 8 weeks
|
Patient-rated PTSD Checklist for DSM-5 (PCL-5).
Time Frame: Baseline to 8 weeks
|
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.
The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the DSM-IV version.
Rating scale descriptors correspond to "Not at all" (0), "A little bit" (1), "Moderately" (2), "Quite a bit" (3), and "Extremely" (4).A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items.
The higher score is associated with poorer outcome.
|
Baseline to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: E. Sherwood Brown, MD, PhD, MBA, UT Southwestern Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2021
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
July 3, 2020
First Submitted That Met QC Criteria
July 3, 2020
First Posted (Actual)
July 9, 2020
Study Record Updates
Last Update Posted (Actual)
August 23, 2021
Last Update Submitted That Met QC Criteria
August 19, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 2020-0171
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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