Post Traumatic Stress DisorderPhase 1NCT04464148
Feasibility Trial of Pregnenolone for Posttraumatic Stress Disorder and Alcohol Use Disorder
A Phase 1 study testing Pregnenolone 250 mg and Pregnenolone 400 mg in people with Post Traumatic Stress Disorder and Alcohol Use Disorder, run by University of Texas Southwestern Medical Center.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Traumatic Stress Disorder, Alcohol Use Disorder
- What is being tested?
- Pregnenolone 250 mg and Pregnenolone 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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.
Read the 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.
- Being tested
- Pregnenolone 250 mg, Pregnenolone 400 mg
- Keywords
- Pregnenolone, PTSD, Alcohol
- Medical subject headings
- Stress Disorders, Post-Traumatic, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnenolone 250 mgDrug
Pregnenolone 250 mg capsule BID (500 mg QD total)
Pregnenolone 400 mgDrug
Pregnenolone 400 mg capsule BID (800 mg QD total)
| Study group | Role | What they receive |
|---|---|---|
| Pregnenolone 250 BID > Pregnenolone 400 BID | Experimental | 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. Receives: Drug: Pregnenolone 250 mg; Drug: Pregnenolone 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
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.
Measured: Baseline to 8 weeks
Standard alcoholic drinks per week
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.
Measured: Baseline to 8 weeks
Timeline Followback (TLFB) heavy drinking days
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.
Measured: Baseline to 8 weeks
Systematic Assessment for Treatment Emergent Events (SAFTEE)
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.
Measured: Baseline to 8 weeks
Patient-rated PTSD Checklist for DSM-5 (PCL-5).
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.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study startDec 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Feasibility study was not initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherwood Brown, MD, PhD, University of Texas Southwestern Medical Center
- Investigators
- E. Sherwood Brown, MD, PhD, MBA, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464148
- Sponsor's protocol ID
- STU 2020-0171
- Status last verified
- Aug 2021
- First submitted
- 3 Jul 2020
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of Pregnenolone for Posttraumatic Stress Disorder and Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04464148
- Acronym / sponsor ID
- STU 2020-0171
- Keywords
- Pregnenolone, PTSD, Alcohol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Feasibility study was not initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnenolone 250 BID > Pregnenolone 400 BID | Experimental | Drug: Pregnenolone 250 mg, Drug: Pregnenolone 400 mgFor 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregnenolone 250 mgPregnenolone 250 mg capsule BID (500 mg QD total) | Drug | Pregnenolone 250 BID > Pregnenolone 400 BID |
| Pregnenolone 400 mgPregnenolone 400 mg capsule BID (800 mg QD total) | Drug | Pregnenolone 250 BID > Pregnenolone 400 BID |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E. Sherwood Brown, MD, PhD, MBA principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pregnenolone 250 mg and Pregnenolone 400 mg in people with Post Traumatic Stress Disorder and Alcohol Use Disorder, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: Baseline to 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.