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.

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
✕. Female that is pregnant or breastfeeding.
✕. Claustrophobic.
✕. 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.

Change in score on the WHODAS 2.0

Timeframe: Baseline to immediate post visit.

NCT IDNCT04313712

SponsorStanford University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-02

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
✕. Female that is pregnant or breastfeeding.
✕. Claustrophobic.
✕. 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.