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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04313712
Recruitment Status : Active, not recruiting
First Posted : March 18, 2020
Last Update Posted : August 9, 2023
Sponsor:
Information provided by (Responsible Party):
Nolan R, Stanford University

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04313712


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Nolan Williams, MD Stanford University
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Responsible Party: Nolan R, Assistant Professor, Stanford University, Stanford University
ClinicalTrials.gov Identifier: NCT04313712    
Other Study ID Numbers: 54095
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: August 2023

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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:
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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