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NCT06810765
Trifecta Research Study: Examining Hormone Replacement Therapy, Magnetic e-Resonance Therapy, Ibogaine, and 5-MeO-DMT in the Treatment of Posttraumatic Stress Disorder and Traumatic Brain Injury-related Cognitive Symptoms
Phase 2 trial testing Hormone Replacement Therapy (HRT) in PTSD - Post Traumatic Stress Disorder. Withdrawn.
1 December 2026
Quick facts
| Lead sponsor | Johns Hopkins University |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 September 2025 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 December 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Hormone Replacement Therapy (HRT)
- Magnetic Resonance Therapy (MeRT)
- ibogaine with magnesium treatment — full drug profile →
- 5-MeO-DMT — full drug profile →
Conditions studied
- PTSD - Post Traumatic Stress Disorder — all drugs for PTSD - Post Traumatic Stress Disorder →
- Cognitive Dysfunction — all drugs for Cognitive Dysfunction →
- Brain Trauma — all drugs for Brain Trauma →
- Brain Injuries — all drugs for Brain Injuries →
Sponsor
Johns Hopkins University
Who can join
18 and older, any sex, with PTSD - Post Traumatic Stress Disorder or Cognitive Dysfunction. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5 (PCL - 5)
Time frame: Up to 12 months follow up
The PTSD Checklist for DSM-5 (PCL-5) is a self-report questionnaire designed to assess the severity of PTSD symptoms in alignment with the DSM-5 diagnostic criteria. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items with higher scores indicating greater symptom severity. Collected - Group 1: Baseline, pre-HRT, pre-MeRT, mid-MeRT (week 3 Me -
Medical Outcomes Study Cognitive Functioning Scale (MOS-CF)
Time frame: UP to 12 months follow up
The Medical Outcomes Study - Cognitive Functioning (MOS-CF) self-report scale consists of 6 items that are designed to measure perceived cognitive functioning. Each item is scored on a 6-point scale (1-6), with 1 being 'all of the time' and 6 being 'none of the time.' Higher scores indicate higher cognitive functioning and lower cognitive symptoms. Collected - Group 1: Baseline, pre-HRT, pre-MeRT, -
Externalized Free Recall with Emotional Words
Time frame: Up to 12 months follow up
In the Externalized Free Recall with Emotional Words task, participants will be presented with a series of emotionally positive, negative, and neutral stimuli (e.g., words or images) and asked to recall the stimuli. The task captures how well individuals retain and recall emotional versus neutral content. Dependent variables include the total number of words recalled, total number of words recalle -
Incidence of Adverse Events
Time frame: Up to 3-months follow-up
Adverse event monitoring at post-treatment and follow-up -
Depressive Symptom Index-Suicidality Subscale (DSI-SS)
Time frame: Up to 12 months follow up
Used to assess severity of suicide ideation. The measure consists of 4 items, each with a Likert-type scale (0-4) indicating the frequency and severity of different aspects of suicidal ideation (e.g., planfulness, control, impulse). Higher scores indicate greater levels of suicidal ideation. Collected - Group 1: Baseline, pre-HRT, pre-MeRT, mid-MeRT (week 3 MeRT), pre-Ibo/5Meo, post-Ibo/5Meo, 3 mo
Sponsor's own description
The Special Operations Care-Fund (SOC-F) will sponsor the application of four treatments - hormone replacement, magnetic resonance brain stimulation, ibogaine, and 5-Meo-DMT - to Special Operations Forces veterans with a history of combat deployments, traumatic brain injury, and problems with mental health and cognitive functioning. An observational study will be conducted in parallel by the Johns Hopkins Center for Psychedelic and Consciousness Research to determine the effectiveness and safety of each treatment, primarily through measuring post-treatment changes in PTSD symptoms and cognitive functioning.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06810765
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Hormone Replacement Therapy (HRT)
Trials testing the same drug.
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Other recruiting trials for PTSD - Post Traumatic Stress Disorder
Currently open trials in the same condition.
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- NCT07069517 — Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD · NA · recruiting
Other Johns Hopkins University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06810765 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
- Last refreshed: 18 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06810765.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing