Blast or Combat ExposureNCT04313712
Pre-post Evaluation of the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans With Repeated Blast Exposure
An observational study of Blast or Combat Exposure and Head Injury Trauma, run by Stanford University at 1 site in United States.
Trial summary
A Pre-post Study Evaluating the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans with Sequelae of Repeated Blast Exposure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Blast or Combat Exposure, Head Injury Trauma
- What is being tested?
- ibogaine with magnesium treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 13 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans with a history of head trauma, combat or blast exposure that have arranged for ibogaine-magnesium therapy in other countries.
Who may be able to join
- 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.
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- 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.
- If female, a status of non-childbearing potential or use of an acceptable form of birth control per the following specific criteria:
- 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
- Childbearing potential, and meets the following criteria:
- 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.
- Negative urinary pregnancy test at screening, confirmed by a negative urinary pregnancy test at randomization prior to receiving study treatment.
- 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.
- Participants must be US citizens.
Who cannot join
- 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.
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- 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.
- 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.
- Any history of cardiovascular problems.
- Any history of liver or kidney problems.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: 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.
Read the 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
- Being tested
- ibogaine with magnesium treatment
- Keywords
- blast exposure, combat exposure, head trauma
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibogaine with magnesium treatmentDrug
Participants will receive magnesium sulfate intravenously and ibogaine orally.
| Study group | Role | What they receive |
|---|---|---|
| Participants | All study participants will be observed before and after they receive ibogaine-magnesium therapy. Receives: Drug: ibogaine with magnesium treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on the WHODAS 2.0
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.
Measured: Baseline to immediate post visit.
Secondary outcomes (1)
Change in score on the WHODAS 2.0
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.
Measured: Baseline to 1-month post visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start15 Nov 2021
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blast or Combat ExposureStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cammie Ellen Rolle, Stanford University
- Investigators
- Cammie Rolle, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313712
- Sponsor's protocol ID
- 54095
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2020
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38182784
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-post Study Evaluating the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans With Sequelae of Repeated Blast Exposure
- ClinicalTrials.gov ID
- NCT04313712
- Acronym / sponsor ID
- 54095
- Conditions
- Blast or Combat Exposure, Head Injury Trauma
- Keywords
- blast exposure, combat exposure, head trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Drug: ibogaine with magnesium treatmentAll study participants will be observed before and after they receive ibogaine-magnesium therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans with a history of head trauma, combat or blast exposure that have arranged for ibogaine-magnesium therapy in other countries.
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ibogaine with magnesium treatmentParticipants will receive magnesium sulfate intravenously and ibogaine orally. | Drug | Participants |
Primary outcome
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.
1 secondary outcome
Change in score on the WHODAS 2.0
Time frame: Baseline to 1-month post visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Derived from this study: PubMed 38182784Cherian 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cammie Rolle, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blast or Combat Exposure and Head Injury Trauma, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in score on the WHODAS 2.0 (time frame: Baseline to immediate post visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04313712, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.