Pre-post Evaluation of the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans With Rep… (NCT04313712) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pre-post Evaluation of the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans With Repeated Blast Exposure
United States30 participantsStarted 2021-11-15
Plain-language summary
A Pre-post Study Evaluating the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans with Sequelae of Repeated Blast Exposure.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female veteran, 18 to 70 years of age, inclusive, at screen.
. Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with the study protocol and communicate with study personnel about adverse events and other clinically important information.
. Has a history of head trauma, combat or blast exposure.
. Scheduled themselves for ibogaine-magnesium therapy at Nouvelle Vie in Mexico.
. Participants must be willing and able to travel to Stanford University before and after ibogaine-magnesium therapy.
. Capable of getting an MRI scan.
. Willing to be video recorded during the consenting process. (to be stored on a secure server, no PHI associated with video recordings)
. Body mass index between 17-35kg/m2.
Exclusion criteria
. Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. History of a neurological disorder (i.e. Parkinson's, epilepsy, dementia, etc.) excluding sequelae of traumatic injury.
. In the judgment of the investigator, the subject is at significant risk for suicidal behavior during the course of their participation in the study.
. History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms.
. Has a clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results.
. Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation.