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
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5 (PCL - 5)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Sponsored by SOC-F Program
排除标准
- •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)
- •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
研究组 & 干预措施
Individuals in this arm will undergo HRT, then Ibogaine and 5-MeO treatment, and then MeRT therapy.
干预措施: Hormone Replacement Therapy (HRT) (Other)
Individuals in this arm will undergo HRT, then Ibogaine and 5-MeO treatment, and then MeRT therapy.
干预措施: Magnetic Resonance Therapy (MeRT) (Other)
Individuals in this arm will undergo HRT, then Ibogaine and 5-MeO treatment, and then MeRT therapy.
干预措施: ibogaine with magnesium treatment (Drug)
Individuals in this arm will undergo HRT, then Ibogaine and 5-MeO treatment, and then MeRT therapy.
干预措施: 5-MeO-DMT (Drug)
Individuals in this arm will undergo HRT, then MeRT therapy, and then Ibogaine and 5-MeO-DMT.
干预措施: Hormone Replacement Therapy (HRT) (Other)
Individuals in this arm will undergo HRT, then MeRT therapy, and then Ibogaine and 5-MeO-DMT.
干预措施: Magnetic Resonance Therapy (MeRT) (Other)
Individuals in this arm will undergo HRT, then MeRT therapy, and then Ibogaine and 5-MeO-DMT.
干预措施: ibogaine with magnesium treatment (Drug)
Individuals in this arm will undergo HRT, then MeRT therapy, and then Ibogaine and 5-MeO-DMT.
干预措施: 5-MeO-DMT (Drug)
结局指标
主要结局
PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5 (PCL - 5)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: Up to 3-months follow-up
Adverse event monitoring at post-treatment and follow-up
Depressive Symptom Index-Suicidality Subscale (DSI-SS)
时间窗: 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
次要结局
未报告次要终点