A Pre-post Study Evaluating the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans with Sequelae of Repeated Blast Exposure.
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 Type
OBSERVATIONAL
Enrollment
30
Participants will receive magnesium sulfate intravenously and ibogaine orally.
Stanford University School of Medicine
Stanford, California, United States
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.
Time frame: Baseline to immediate post visit.
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.
Time frame: Baseline to 1-month post visit.
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