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Active, not recruitingN/A

Pre-post Evaluation of the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans With Repeated Blast Exposure

NCT04313712 · Stanford University

Closed to entry
Status
Not accepting participants
Not applicable
Phase
30
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

A Pre-post Study Evaluating the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans with Sequelae of Repeated Blast Exposure.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in score on the WHODAS 2.0

    Measured over Baseline to immediate post visit.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Male or female veteran, 18 to 70 years of age, inclusive, at screen. 2. 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. 3. Has a history of head trauma, combat or blast exposure. 4. Scheduled themselves for ibogaine-magnesium therapy at Nouvelle Vie in Mexico. 5. Participants must be willing and able to travel to Stanford University before and after ibogaine-magnesium therapy. 6. Capable of getting an MRI scan. 7. Willing to be video recorded during the consenting process. (to be stored on a secure server, no PHI associated with video recordings) 8. Body mass index between 17-35kg/m2. 9. If female, a status of non-childbearing potential or use of an acceptable form of birth control per the following specific criteria: 1. Non-childbearing potential (e.g., physiologically incapable of becoming pregnant, i.e., permanently sterilized (status post hysterectomy, bilateral tubal ligation), or is post-menopausal with her last menses at least one year prior to screening); or 2. Childbearing potential, and meets the following criteria: i. Childbearing potential, including women using any form of hormonal birth control, on hormone replacement therapy started prior to 12 months of amenorrhea, using an intrauterine device (IUD), having a monogamous relationship with a partner who has had a vasectomy, or is sexually abstinent. ii. Negative urinary pregnancy test at screening, confirmed by a negative urinary pregnancy test at randomization prior to receiving study treatment. iii. Willing and able to continuously use one of the following methods of birth control during the course of the study, defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly: implants, injectable or patch hormonal contraception, oral contraceptives, IUD, double-barrier contraception, sexual abstinence. The form of birth control will be documented at screening and baseline. 10. Participants must be US citizens. Exclusion Criteria: 1. Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study. 2. Female that is pregnant or breastfeeding. 3. Claustrophobic. 4. History of a neurological disorder (i.e. Parkinson's, epilepsy, dementia, etc.) excluding sequelae of traumatic injury. 5. In the judgment of the investigator, the subject is at significant risk for suicidal behavior during the course of their participation in the study. 6. History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms. 7. Has a clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results. 8. Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation. 9. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation. 10. Any history of cardiovascular problems. 11. Any history of liver or kidney problems.

Where

1 study site

FacilityCityRegionCountry
Stanford University School of MedicineStanfordCaliforniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04313712 on ClinicalTrials.gov →

Last updated in the registry 2024-12-20. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits