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

• ClinicalTrials.gov Identifier: NCT04313712
• Recruitment Status: Active, not recruiting
• First Posted: March 18, 2020
• Last Update Posted: August 9, 2023
• Sponsor: Stanford University
• Information provided by (Responsible Party): Nolan R, Stanford University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Blast or Combat Exposure; Head Injury Trauma	Drug: ibogaine with magnesium treatment

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Pre-post Study Evaluating the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans With Sequelae of Repeated Blast Exposure
• Actual Study Start Date: November 15, 2021
• Estimated Primary Completion Date: February 2024
• Estimated Study Completion Date: February 2024

Groups and Cohorts

Group/Cohort	Intervention/treatment
Participants; All study participants will be observed before and after they receive ibogaine-magnesium therapy.	Drug: ibogaine with magnesium treatment; Participants will receive magnesium sulfate intravenously and ibogaine orally.

Outcome Measures

Primary Outcome Measures :

1. Change in score on the WHODAS 2.0 [ Time Frame: Baseline to immediate post visit. ]
   The WHODAS 2.0 is a generic assessment of disability across six domains of functioning including cognition, mobility, self-care, interpersonal relationships, life activities, and community activities. The higher the score, the greater the level of self-reported disability in functioning. Scores from baseline will be compared to scores at the immediate post-treatment.

Secondary Outcome Measures :

1. Change in score on the WHODAS 2.0 [ Time Frame: Baseline to 1-month post visit. ]
   The WHODAS 2.0 is a generic assessment of disability across six domains of functioning including cognition, mobility, self-care, interpersonal relationships, life activities, and community activities. The higher the score, the greater the level of self-reported disability in functioning. Scores from baseline will be compared to scores at 1-month post-visit.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Veterans with a history of head trauma, combat or blast exposure that have arranged for ibogaine-magnesium therapy in other countries.

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.

Contacts and Locations

Locations

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Nolan Williams, MD; Stanford University

More Information

• Responsible Party: Nolan R, Assistant Professor, Stanford University, Stanford University
• ClinicalTrials.gov Identifier: NCT04313712
• Other Study ID Numbers: 54095
• First Posted: March 18, 2020
• Last Update Posted: August 9, 2023
• Last Verified: August 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nolan R, Stanford University:

blast exposure; combat exposure; head trauma

Additional relevant MeSH terms:

Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Ibogaine; Hallucinogens; Physiological Effects of Drugs; Psychotropic Drugs; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action