PTSD - Post Traumatic Stress DisorderPhase 2NCT06810765
Trifecta Research Study
A Phase 2 study testing Hormone Replacement Therapy (HRT), Magnetic Resonance Therapy (MeRT) and ibogaine with magnesium treatment in people with PTSD - Post Traumatic Stress Disorder and Cognitive Dysfunction, run by Johns Hopkins University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder, Cognitive Dysfunction, Brain Trauma
- What is being tested?
- Hormone Replacement Therapy (HRT), Magnetic Resonance Therapy (MeRT) and ibogaine with magnesium treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2025to Dec 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Sponsored by SOC-F Program
Who cannot join
- Diagnosis of Schizophrenia, Bipolar I or II disorder for which patient has been hospitalized or medicated, Depersonalization and/or Derealization Disorder
- Cerebellar dysfunction, Epilepsy, Psychosis or acute confusional state, Dementia
- Prolonged corrected QT interval (QTc) Interval (450ms in males; 470ms in females)
- History of heart failure or hypertrophic heart
- Active blood clots (e.g., Pulmonary embolism, Deep vein thrombosis)
- Major respiratory conditions (e.g., Emphysema, Cystic fibrosis)
Show all 11Show fewer
- Severe chronic gastrointestinal issues (e.g., bleeding ulcer, leaky gut syndrome)
- Within 6 months of surgeries
- Abnormal blood test results (e.g., potassium or magnesium outside normal range)
- Impaired kidney or liver function
- Refusal to taper off of selective serotonin reuptake inhibitor (SSRI) medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Center for Psychedelic and Consciousness Research
Baltimore, Maryland, 21224
About this study
Official title: 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
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.
Read the detailed description
This study uses an interventional design to evaluate the safety and effectiveness of Hormone Replacement Therapy (HRT), Magnetic e-resonance therapy (MeRT), Ibogaine, and 5-methoxy-N,N-dimethyltryptamine (5-Meo-DMT) in the treatment of PTSD and cognitive symptoms associated with combat deployment and traumatic brain injury (TBI) among Special Operations Forces (SOF) veterans. Forty participants will be recruited for this program, which combines state-of-the-art therapies tailored to each individual's needs, aiming to improve psychological and cognitive health outcomes in a population with severe, treatment-resistant conditions.
Participants will be assigned by The Special Operations Care Fund (SOC-F) to one of two sequences of interventions through SOC-F's contracted providers. One group will receive HRT, then MeRT, then Ibogaine and 5-MeO-DMT. The other group will receive HRT, then Ibogaine and 5-Meo-DMT, then MeRT. The study design includes self-reported surveys, informant reports, and cognitive task assessments, all of which will monitor the interventions' impact on participants.
The general purpose is to explore these treatments' potential to promote meaningful symptom improvement and enhanced cognitive function. A combination of subjective and objective data will allow a comprehensive assessment of treatment effectiveness and safety, with the ultimate goal of informing future clinical trials and veteran treatment services.
Specific aims and hypotheses include the following:
Aim 1: Investigate the therapeutic effect of all treatments on PTSD symptoms and cognitive function in SOF veterans with PTSD and cognitive difficulties.
H1. Treatment will be associated with reduced self-reported PTSD symptoms at 3-month follow-up (FU).
H2. Treatment will be associated with improved self-reported cognitive functioning at 3-month follow-up.
H3. Treatment will be associated with improved emotional memory, indexed by the externalizing free recall task, at post-treatment.
Aim 2: Investigate the incremental therapeutic effect of Ibogaine and 5-Meo-DMT on PTSD symptoms and cognitive function relative to HRT and Repetitive Transcranial Magnetic Stimulation (rTMS) therapy in SOF veterans with PTSD and cognitive difficulties.
H4. Ibogaine/5-Meo-DMT will be associated with an incremental reduction in self-reported PTSD symptoms following HRT and rTMS therapy.
H5. Ibogaine/5-Meo-DMT will be associated with an incremental improvement in self-reported cognitive functioning following HRT and rTMS therapy.
H6. Ibogaine/5-Meo-DMT will be associated with an incremental improvement in emotional memory, indexed by the externalizing free recall task, following HRT and rTMS therapy.
Aim 3: Investigate whether the order of interventions differentially impacts PTSD and cognitive symptoms in SOF veterans with PTSD and cognitive difficulties.
No formal hypotheses
Aim 4: Investigate adverse events related to each of the interventions. No formal hypotheses
- Conditions
- PTSD - Post Traumatic Stress Disorder, Cognitive Dysfunction, Brain Trauma, Brain Injuries
- Being tested
- Hormone Replacement Therapy (HRT), Magnetic Resonance Therapy (MeRT), ibogaine with magnesium treatment, 5-MeO-DMT
- Keywords
- PTSD, military veteran, cognitive functioning, Traumatic Brain Injury (TBI), psychedelics, Transcranial Magnetic Stimulation (TMS)
- Medical subject headings
- Combat Disorders, Cognitive Dysfunction, Brain Injuries, Traumatic, Brain Injuries, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone Replacement Therapy (HRT)Other
Hormone Replacement Therapy (HRT) is a medical treatment that involves restoring healthy endocrine functioning through supplementing or balancing hormones, such as testosterone or estrogen, to address deficiencies caused by injury, aging, or stress.
Magnetic Resonance Therapy (MeRT)Other
Also called Transcranial Magnetic Stimulation
MeRT, an EEG (electroencephalography)-guided Repetitive Transcranial Magnetic Stimulation therapy, is a non-invasive treatment that uses magnetic pulses to stimulate specific areas of the brain, guided by an individual's brain patterns. MeRT is a neuromodulatory tool that has shown therapeutic efficacy in relation to a number of psychopathological targets including PTSD, depression, and TBI-related cognitive impairment through promoting cortical excitability, modulating neurotransmission, and restoring neuroplasticity.
ibogaine with magnesium treatmentDrug
Ibogaine, an indole alkaloid that interacts with mu opioid, kappa opioid, N-methyl-D-aspartate receptor (NMDA), and nicotinic acetylcholine receptors, shows early signs of effectiveness as a rapid-acting treatment for a number of mental health disorders including addiction. It is believed to work by promoting neuroplasticity and modulating brain chemistry, which may help reset dysfunctional neural circuits. The treatment is unique in its psychoactive properties, offering a deeply introspective experience that may help individuals process emotional material from the individual's lives.
5-MeO-DMTDrug
5-MeO-DMT, as described in the study, is a 5-HT 2A agonist compound used in previous clinical research to address depression. Unlike other treatments, 5-MeO-DMT acts rapidly and has a short duration of action, offering an intense but time-limited psychoactive state. Its potential to enhance neuroplasticity and recalibrate dysfunctional brain networks makes it a unique approach for addressing the complex interplay of psychological and neurological symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Individuals in this arm will undergo HRT, then Ibogaine and 5-MeO treatment, and then MeRT therapy. | Experimental | Not described Receives: Other: Hormone Replacement Therapy (HRT); Other: Magnetic Resonance Therapy (MeRT); Drug: ibogaine with magnesium treatment; Drug: 5-MeO-DMT |
| Individuals in this arm will undergo HRT, then MeRT therapy, and then Ibogaine and 5-MeO-DMT. | Active comparator | Not described Receives: Other: Hormone Replacement Therapy (HRT); Other: Magnetic Resonance Therapy (MeRT); Drug: ibogaine with magnesium treatment; Drug: 5-MeO-DMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5 (PCL - 5)
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 MeRT), pre-Ibo/5Meo, post-Ibo/5Meo, 3 month follow up (MFU), 6 MFU, 12 MFU; Group 2: Baseline, pre-HRT, pre-Ibo/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU
Measured: Up to 12 months follow up
Medical Outcomes Study Cognitive Functioning Scale (MOS-CF)
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, mid-MeRT (week 3 MeRT), pre-Ibo/5Meo, post-Ibo/5Meo, 3 month follow up (MFU), 6 MFU, 12 MFU; Group 2: Baseline, pre-HRT, pre-Ibo/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU
Measured: UP to 12 months follow up
Externalized Free Recall with Emotional Words
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 recalled as a function of emotion, total number of recall intrusions, total number of prior-list intrusions as a function of emotion, overall monitoring accuracy percentage, and monitoring accuracy percentage, as a function of emotion. Collected - Group 1: Baseline, pre-HRT, pre-MeRT, mid-MeRT (week 3 MeRT), pre-Ibo/5Meo, post-Ibo/5Meo, 3 month follow up (MFU), 6 MFU, 12 MFU; Group 2: Baseline, pre-HRT, pre-Ibo/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU
Measured: Up to 12 months follow up
Incidence of Adverse Events
Adverse event monitoring at post-treatment and follow-up
Measured: Up to 3-months follow-up
Depressive Symptom Index-Suicidality Subscale (DSI-SS)
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 month follow up (MFU), 6 MFU, 12 MFU; Group 2: Baseline, pre-HRT, pre-Ibo/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU
Measured: Up to 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Study is being conducted externally.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Special Operators Care Fund
- Responsible party
- Sponsor
- Investigators
- Sandeep Nayak, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810765
- Sponsor's protocol ID
- IRB00473770
- Status last verified
- Aug 2025
- First submitted
- 24 Jan 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06810765
- Acronym / sponsor ID
- IRB00473770
- Conditions
- PTSD - Post Traumatic Stress Disorder, Cognitive Dysfunction, Brain Trauma, Brain Injuries
- Keywords
- PTSD, military veteran, cognitive functioning, Traumatic Brain Injury (TBI), psychedelics, Transcranial Magnetic Stimulation (TMS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is being conducted externally.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Special Operators Care Fund
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Feb 2025 (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.
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.
Detailed description
This study uses an interventional design to evaluate the safety and effectiveness of Hormone Replacement Therapy (HRT), Magnetic e-resonance therapy (MeRT), Ibogaine, and 5-methoxy-N,N-dimethyltryptamine (5-Meo-DMT) in the treatment of PTSD and cognitive symptoms associated with combat deployment and traumatic brain injury (TBI) among Special Operations Forces (SOF) veterans. Forty participants will be recruited for this program, which combines state-of-the-art therapies tailored to each individual's needs, aiming to improve psychological and cognitive health outcomes in a population with severe, treatment-resistant conditions.
Participants will be assigned by The Special Operations Care Fund (SOC-F) to one of two sequences of interventions through SOC-F's contracted providers. One group will receive HRT, then MeRT, then Ibogaine and 5-MeO-DMT. The other group will receive HRT, then Ibogaine and 5-Meo-DMT, then MeRT. The study design includes self-reported surveys, informant reports, and cognitive task assessments, all of which will monitor the interventions' impact on participants.
The general purpose is to explore these treatments' potential to promote meaningful symptom improvement and enhanced cognitive function. A combination of subjective and objective data will allow a comprehensive assessment of treatment effectiveness and safety, with the ultimate goal of informing future clinical trials and veteran treatment services.
Specific aims and hypotheses include the following:
Aim 1: Investigate the therapeutic effect of all treatments on PTSD symptoms and cognitive function in SOF veterans with PTSD and cognitive difficulties.
H1. Treatment will be associated with reduced self-reported PTSD symptoms at 3-month follow-up (FU).
H2. Treatment will be associated with improved self-reported cognitive functioning at 3-month follow-up.
H3. Treatment will be associated with improved emotional memory, indexed by the externalizing free recall task, at post-treatment.
Aim 2: Investigate the incremental therapeutic effect of Ibogaine and 5-Meo-DMT on PTSD symptoms and cognitive function relative to HRT and Repetitive Transcranial Magnetic Stimulation (rTMS) therapy in SOF veterans with PTSD and cognitive difficulties.
H4. Ibogaine/5-Meo-DMT will be associated with an incremental reduction in self-reported PTSD symptoms following HRT and rTMS therapy.
H5. Ibogaine/5-Meo-DMT will be associated with an incremental improvement in self-reported cognitive functioning following HRT and rTMS therapy.
H6. Ibogaine/5-Meo-DMT will be associated with an incremental improvement in emotional memory, indexed by the externalizing free recall task, following HRT and rTMS therapy.
Aim 3: Investigate whether the order of interventions differentially impacts PTSD and cognitive symptoms in SOF veterans with PTSD and cognitive difficulties.
No formal hypotheses
Aim 4: Investigate adverse events related to each of the interventions. No formal hypotheses
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals in this arm will undergo HRT, then Ibogaine and 5-MeO treatment, and then MeRT therapy. | Experimental | Other: Hormone Replacement Therapy (HRT), Other: Magnetic Resonance Therapy (MeRT), Drug: ibogaine with magnesium treatment, Drug: 5-MeO-DMT |
| Individuals in this arm will undergo HRT, then MeRT therapy, and then Ibogaine and 5-MeO-DMT. | Active comparator | Other: Hormone Replacement Therapy (HRT), Other: Magnetic Resonance Therapy (MeRT), Drug: ibogaine with magnesium treatment, Drug: 5-MeO-DMT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age
- Sponsored by SOC-F Program
Key exclusion criteria (11 listed)
- Diagnosis of Schizophrenia, Bipolar I or II disorder for which patient has been hospitalized or medicated, Depersonalization and/or Derealization Disorder
- Cerebellar dysfunction, Epilepsy, Psychosis or acute confusional state, Dementia
- Prolonged corrected QT interval (QTc) Interval (450ms in males; 470ms in females)
- History of heart failure or hypertrophic heart
- Active blood clots (e.g., Pulmonary embolism, Deep vein thrombosis)
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 |
|---|---|---|
| Hormone Replacement Therapy (HRT)Hormone Replacement Therapy (HRT) is a medical treatment that involves restoring healthy endocrine functioning through supplementing or balancing hormones, such as testosterone or estrogen, to address deficiencies caused by injury, aging, or stress. | Other | Individuals in this arm will undergo HRT, then Ibogaine and 5-MeO treatment, and then MeRT therapy., Individuals in this arm will undergo HRT, then MeRT therapy, and then Ibogaine and 5-MeO-DMT. |
| Magnetic Resonance Therapy (MeRT)Also: Transcranial Magnetic StimulationMeRT, an EEG (electroencephalography)-guided Repetitive Transcranial Magnetic Stimulation therapy, is a non-invasive treatment that uses magnetic pulses to stimulate specific areas of the brain, guided by an individual's brain patterns. MeRT is a neuromodulatory tool that has shown therapeutic efficacy in relation to a number of psychopathological targets including PTSD, depression, and TBI-related cognitive impairment through promoting cortical excitability, modulating neurotransmission, and restoring neuroplasticity. | Other | Individuals in this arm will undergo HRT, then Ibogaine and 5-MeO treatment, and then MeRT therapy., Individuals in this arm will undergo HRT, then MeRT therapy, and then Ibogaine and 5-MeO-DMT. |
| ibogaine with magnesium treatmentIbogaine, an indole alkaloid that interacts with mu opioid, kappa opioid, N-methyl-D-aspartate receptor (NMDA), and nicotinic acetylcholine receptors, shows early signs of effectiveness as a rapid-acting treatment for a number of mental health disorders including addiction. It is believed to work by promoting neuroplasticity and modulating brain chemistry, which may help reset dysfunctional neural circuits. The treatment is unique in its psychoactive properties, offering a deeply introspective experience that may help individuals process emotional material from the individual's lives. | Drug | Individuals in this arm will undergo HRT, then Ibogaine and 5-MeO treatment, and then MeRT therapy., Individuals in this arm will undergo HRT, then MeRT therapy, and then Ibogaine and 5-MeO-DMT. |
| 5-MeO-DMT5-MeO-DMT, as described in the study, is a 5-HT 2A agonist compound used in previous clinical research to address depression. Unlike other treatments, 5-MeO-DMT acts rapidly and has a short duration of action, offering an intense but time-limited psychoactive state. Its potential to enhance neuroplasticity and recalibrate dysfunctional brain networks makes it a unique approach for addressing the complex interplay of psychological and neurological symptoms. | Drug | Individuals in this arm will undergo HRT, then Ibogaine and 5-MeO treatment, and then MeRT therapy., Individuals in this arm will undergo HRT, then MeRT therapy, and then Ibogaine and 5-MeO-DMT. |
Primary outcome
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 MeRT), pre-Ibo/5Meo, post-Ibo/5Meo, 3 month follow up (MFU), 6 MFU, 12 MFU; Group 2: Baseline, pre-HRT, pre-Ibo/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU
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, mid-MeRT (week 3 MeRT), pre-Ibo/5Meo, post-Ibo/5Meo, 3 month follow up (MFU), 6 MFU, 12 MFU; Group 2: Baseline, pre-HRT, pre-Ibo/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU
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 recalled as a function of emotion, total number of recall intrusions, total number of prior-list intrusions as a function of emotion, overall monitoring accuracy percentage, and monitoring accuracy percentage, as a function of emotion. Collected - Group 1: Baseline, pre-HRT, pre-MeRT, mid-MeRT (week 3 MeRT), pre-Ibo/5Meo, post-Ibo/5Meo, 3 month follow up (MFU), 6 MFU, 12 MFU; Group 2: Baseline, pre-HRT, pre-Ibo/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU
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 month follow up (MFU), 6 MFU, 12 MFU; Group 2: Baseline, pre-HRT, pre-Ibo/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU
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 22 Aug 2025.
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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.
Sandeep Nayak, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hormone Replacement Therapy (HRT), Magnetic Resonance Therapy (MeRT) and ibogaine with magnesium treatment in people with PTSD - Post Traumatic Stress Disorder and Cognitive Dysfunction, run by Johns Hopkins University at 1 site in United States.
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 2 inclusion and 11 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 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5 (PCL - 5) (time frame: Up to 12 months follow up). 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 22 Aug 2025.