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Home/Research/Ibogaine/Safety & Risk Management

Ibogaine for Safety & Risk Management

14 papers and 2 clinical trials exploring ibogaine as a treatment for safety & risk management.

CompoundIndole Alkaloid

Ibogaine

A unique indole alkaloid with complex pharmacology, investigated primarily for its capacity to interrupt substance use disorders and withdrawal.

Full Ibogaine profile
IndicationMental health disorders affect over 900 million people worldwide, with conditions like PTSD and depression being among the most prevalent.

Safety & Risk Management

Safety and risk management in psychedelic therapy remains a critical area of research, necessitating vigilant assessment of potential adverse effects as clinical usage expands. Current efforts focus on ensuring that therapeutic practices minimise harm while maximising efficacy for a range of conditions.

Full Safety & Risk Management profile

Academic Research

14 papers
Open Accessindividual

Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD A Randomized Clinical Trial

In a multicentre, double‑blind, placebo‑controlled phase 2 trial of 65 adults with chronic PTSD, once‑weekly oral TSND‑201 produced significantly greater reductions in clinician‑rated PTSD severity (CAPS‑5; LS mean difference 9.64, P = .01) and improvements in self‑reported symptoms, functioning and depression versus placebo. TSND‑201 was generally well tolerated — common adverse events included headache, decreased appetite, nausea, dizziness and transient blood‑pressure increases — supporting its potential as a rapid‑acting, durable treatment for PTSD.

Published
February 18, 2026
Journal
JAMA Psychiatry
Authors
Jones, A., Warner-Schmidt, J., Kwak, H., Stogniew, M., Mandell, B., Ching, T. H., Stein, M. B., Kelmendi, B.
Open Accessindividual

Magnesium-ibogaine therapy in veterans with traumatic brain injuries

This observational study (n=30) evaluates ibogaine (up to 980mg/70kg) in combination with magnesium (1-2 hours before and 12 hours later) in male Special Operations Forces veterans with predominantly mild traumatic brain injury (mTBI). The study assessed changes in disability, PTSD, depression, and anxiety immediately and one month after treatment using various scales. Results show significant improvements in functioning and psychological symptoms with no serious adverse events.

Published
January 5, 2024
Journal
Nature Medicine
Authors
Cherian, K. N., Keynan, J. N., Anker, L., Faerman, A., Brown, R. E., Shamma, A., Keynan, O., Coetzee, J. P., Batail, J. M., Phillips, A., Bassa, N. J., Sahlem, G. L., Inzunza, J., Millar, T., Dickinson, J., Rol, C. E., Keller, J., Adamson, M., Kratter, I. H., Williams, N. R.
Paywallmeta

A systematic literature review of clinical trials and therapeutic applications of ibogaine

This systematic review (2021) explores clinical trials involving ibogaine and noribogaine. Across the number of trials included, a total of 705 individuals were treated with either ibogaine or noribogaine. It was found that such interventions may be useful for treating substance use disorders, alleviating withdrawal symptoms and cravings. Importantly, a number of severe side effects, including death, that have been recorded in the trials are discussed.

Published
July 1, 2022
Journal
Journal of Substance Abuse Treatment
Authors
Köck, P., Frölich, K., Walter, M., Lang, U., Dürsteler, K. M., Köck, P.
Open Accessmeta

The adverse events of ibogaine in humans: an updated systematic review of the literature (2015-2020)

This review (s=18) did a qualitative analysis of studies with ibogaine and describes the acute adverse events (cardiac, gastrointestinal, neurological) and long-lasting effects (persistent cardiac, psychiatric, neurological). The authors note that phase I studies with standardized products are necessary as the products quantity and mix was widely varied.

Published
August 18, 2021
Journal
Psychopharmacology
Authors
Ona, G., Rocha, J. M., Bouso, J. C., Hallak, J. E., Borràs, T., Colomina, M. T., Dos Santos, R. G.
Paywallindividual

An analog of psychedelics restores functional neural circuits disrupted by unpredictable stress

In mice subjected to unpredictable mild stress, a single dose of the psychedelic analogue tabernanthalog (TBG) reduced anxiety and rescued deficits in sensory processing and cognitive flexibility. TBG achieved this by promoting regrowth of excitatory dendritic spines, lowering baseline neuronal activity and restoring stimulus‑dependent responses in somatosensory cortical circuits.

Published
May 25, 2021
Journal
Molecular Psychiatry
Authors
Lu, J., Tjia, M., Mullen, B., Cao, B., Lukasiewicz, K., Shah-Morales, S., Weiser, S., Cameron, L. P., Olson, D. E., Chen, L., Zuo, Y.
Open Accessmeta

Ibogaine Detoxification Transitions Opioid and Cocaine Abusers Between Dependence and Abstinence: Clinical Observations and Treatment Outcomes

This review of open-label case series (n=191) examined the safety and efficacy of ibogaine for opioid and cocaine detoxification. It finds that ibogaine administration reduced drug cravings and withdrawal symptoms without significant adverse events, supporting its development for medically supervised detoxification.

Published
June 5, 2018
Journal
Frontiers in Pharmacology
Authors
Logrip, M. L., Mash, D. C., Duque, L., Page, B., Allen-Ferdinand, K.

Clinical Trials

2 trials
CompletedPhase II

Ibogaine in the Treatment of Alcoholism: a Randomized, Double-blind, Placebo-controlled, Escalating-dose, Phase 2 Trial

The aim of the present study is to evaluate the safety, tolerability and efficacy of increasing doses of ibogaine in 12 alcoholic patients.

Started
October 1, 2021
Type
interventional
Blinding
none
Randomized
Yes
Registry ID
NCT03380728
CompletedPhase I

The role of CYP2D6 in the pharmacokinetics of ibogaine in healthy volunteers

This randomised, double-blind, placebo-controlled trial (n=24) investigates the role of CYP2D6 in the pharmacokinetics of ibogaine (20mg) in healthy volunteers.

Started
July 1, 2013
Type
interventional
Blinding
single
Randomized
Yes
Registry ID
ACTRN12613000324718

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