Trifecta Research Study - An Observational Study Evaluating the Impact of Ibogaine-Magnesium, 5-MeO-DMT, Magnetic e-Resonance Therapy, and Physiological Supplementation in Special Operations Forces Combat Veterans
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
- 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
This observational study evaluates the impact of Ibogaine-Magnesium (IM), 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), Magnetic e-Resonance Therapy (MeRT), and Physiological Supplementation (PS) on posttraumatic stress disorder (PTSD) and traumatic brain injury-related cognitive symptoms among Special Operations Forces (SOF) combat veterans.
详细描述
Approximately forty participants took part in a program of experimental interventions and therapies that was created to improve psychological and cognitive health outcomes in a population with severe, treatment-resistant conditions. Participants were obtained from a cohort of SOF veterans who were already seeking these therapies through the Special Operations Care-Fund (SOC-F) and chose to volunteer for the study. Participants were assigned by SOC-F to one of two sequences of interventions through SOC-F's care providers. One group received PS, then MeRT, then IM and 5-MeO-DMT. The other group received PS, then IM and 5-MeO-DMT, then MeRT. PS preceded the other interventions in each condition. The study design includes self-report and informant-report questionnaires and cognitive task assessments, all of which monitor the interventions' impact on health outcomes. The general purpose is to explore the potential for this combination of treatments to improve mental health and cognitive function. A collection of subjective and objective data will allow a comprehensive assessment of therapeutic impact, with the ultimate goal of informing future clinical trials and veteran treatment services. This project was formerly registered on clinicaltrials.gov (NCT06810765).
Aims and Hypotheses:
Aim 1: Investigate the impact of all interventions on PTSD symptoms and cognitive function in SOF veterans with PTSD and cognitive difficulties.
H1.1. Collectively, program interventions will be associated with reduced self-reported PTSD symptoms at 3-month follow-up (3MFU).
H1.2. Collectively, program interventions will be associated with improved self-reported cognitive functioning at 3MFU.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •Sponsored by SOC-F Program
排除标准
- •(evaluated by SOC-F, not Axial Therapeutic Research):
- •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
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) will be obtained by summing the scores for each of the 20 items with higher scores indicating greater symptom severity. Data Collected: Group/Sequence A: Baseline, pre-PS, pre-IM/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU; - Group/Sequence B: Baseline, pre-PS, pre-MeRT, mid-MeRT (week 3 MeRT), pre-IM/5Meo, post-IM/5Meo, 3 month follow up (MFU), 6MFU, 12MFU.
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/Sequence 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/Sequence 2: Baseline, pre-HRT, pre-Ibo/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU
Stroop Squared Task
时间窗: Up to 12 months follow-up
In the Stroop Squared Task, participants will select words corresponding to the color of the stimulus word given. For example, participants will name the color of the ink a word is printed in while ignoring the word itself (e.g., the word "BLUE" printed in red ink). The task primarily measures cognitive inhibition. Each participant will receive one score indexing the delay in reaction time caused by the mismatch between word and color. Data Collected: Group/Sequence A: Baseline, pre-PS, pre-IM/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU; - Group/Sequence B: Baseline, pre-PS, pre-MeRT, mid-MeRT (week 3 MeRT), pre-IM/5Meo, post-IM/5Meo, 3MFU, 6MFU, 12MFU.
Externalized Free Recall with Emotional Words Task
时间窗: Up to 15 weeks (Post-MeRT for Group A, Post-IM/5MeO for Group B)
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: V1. The proportion of total words correctly recalled of total words administered V1.1. The proportion of recalled negative words of all words recalled V1.2. The proportion of recalled positive words of all words recalled V1.3. The proportion of recalled neutral words of all words recalled V2. The absolute number of total recall intrusions V2.1. The proportion of intruding negative words of all intruding words V2.2. The proportion of intruding positive words of all intruding words V2.3. The proportion of intruding neutral words of all intruding words Data Collected: Group/Sequence A: pre-PS, Post-MeRT; Group/Sequence B: pre-PS, post-IM/5Meo.
次要结局
- Depressive Symptom Index-Suicidality Subscale (DSI-SS)(Up to 12 month follow-up)
- Adverse Events(Up to 3-month follow-up)