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

NCT ID: NCT04313712

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2025-02-28

Brief Summary

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

Detailed Description

Traumatic brain injury (TBI) is a leading cause of disability worldwide and is particularly common among combat veterans. Deleterious sequelae can include functional impairments and comorbid psychiatric syndromes such as posttraumatic stress disorder (PTSD), depression, and anxiety. Special Operations Forces Veterans (SOV) may be at an elevated risk for these complications, leading some to seek treatment alternatives like the oneirogen ibogaine despite limited evidence of safety or efficacy.

We will assess the safety profile of the compound by assessing unexpected or serious adverse events.

The primary outcome will be change in the World Health Organization Disability Assessment Schedule 2.0 (WHODAS) from baseline to post-treatment, with change from baseline to the one-month follow-up a secondary outcome.

Conditions

Blast or Combat Exposure; Head Injury Trauma

Keywords

blast exposure; combat exposure; head trauma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants

All study participants will be observed before and after they receive ibogaine-magnesium therapy.

ibogaine with magnesium treatment

Intervention Type: DRUG

Participants will receive magnesium sulfate intravenously and ibogaine orally.

Interventions

ibogaine with magnesium treatment

Participants will receive magnesium sulfate intravenously and ibogaine orally.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Nolan R

Assistant Professor, Stanford University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nolan Williams, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

Cherian KN, Keynan JN, Anker L, Faerman A, Brown RE, Shamma A, Keynan O, Coetzee JP, Batail JM, Phillips A, Bassano NJ, Sahlem GL, Inzunza J, Millar T, Dickinson J, Rolle CE, Keller J, Adamson M, Kratter IH, Williams NR. Magnesium-ibogaine therapy in veterans with traumatic brain injuries. Nat Med. 2024 Feb;30(2):373-381. doi: 10.1038/s41591-023-02705-w. Epub 2024 Jan 5.

Reference Type: DERIVED

PMID: 38182784 (View on PubMed)

Other Identifiers

54095

Identifier Type: -

Identifier Source: org_study_id