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Pre-post Evaluation of the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans With Repeated Blast Exposure
Trial ID: NCT04313712
A Pre-post Study Evaluating the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans with Sequelae of Repeated Blast Exposure.
A Pre-post Study Evaluating the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans With Sequelae of Repeated Blast Exposure
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
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
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.
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.
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
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.
drug: ibogaine with magnesium treatment
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nick Bassano, MSW