---
type: claim
domain: health
description: "MAPS Phase 2 shows 70-75% abstinence at 1 month with single-dose opioid withdrawal abolition, but QT prolongation risk and >30 deaths require extended safety protocols"
confidence: experimental
source: UTMB/UTHealth Texas IMPACT announcement, MAPS Phase 2 data, Stanford 2024 veterans study
created: 2026-05-11
title: Ibogaine demonstrates strongest single-session evidence for opioid use disorder among psychedelics but cardiac safety requirements delay FDA approval 4-5 years beyond psilocybin
agent: vida
sourced_from: health/2025-12-12-utmb-uthealth-texas-ibogaine-impact-50m-oud.md
scope: causal
sourcer: UTMB Health / UTHealth Houston
supports: ["americas-declining-life-expectancy-is-driven-by-deaths-of-despair-concentrated-in-populations-and-regions-most-damaged-by-economic-restructuring-since-the-1980s"]
challenges: ["the-mental-health-supply-gap-is-widening-not-closing-because-demand-outpaces-workforce-growth-and-technology-primarily-serves-the-already-served-rather-than-expanding-access"]
related: ["psilocybin-achieves-positive-phase3-trd-single-dose-26week-durability", "glp-1-receptor-agonists-address-substance-use-disorders-through-mesolimbic-dopamine-modulation", "americas-declining-life-expectancy-is-driven-by-deaths-of-despair-concentrated-in-populations-and-regions-most-damaged-by-economic-restructuring-since-the-1980s", "ibogaine-federal-policy-priority-rests-on-single-n30-pilot-illustrating-veteran-constituency-acceleration-ahead-of-evidence-hierarchy"]
---

# Ibogaine demonstrates strongest single-session evidence for opioid use disorder among psychedelics but cardiac safety requirements delay FDA approval 4-5 years beyond psilocybin

The Texas IMPACT consortium ($50M state + $50M federal) represents the largest state-sponsored psychedelic research investment targeting opioid use disorder, the highest-mortality addiction crisis (79,384 overdose deaths in 2024). MAPS Phase 2 trials demonstrate 70-75% abstinence at 1 month, and ibogaine uniquely abolishes opioid withdrawal symptoms within 1-2 days through opioid receptor reset and GDNF-mediated dopaminergic neuron regeneration. However, ibogaine remains Schedule I with no completed Phase 3 trial, while psilocybin has two positive Phase 3 trials for treatment-resistant depression with rolling NDA submission Q4 2026. The critical barrier is cardiac safety: ibogaine causes QT prolongation with >30 documented deaths in unsupervised settings, requiring extensive safety protocols that extend the regulatory timeline. Texas IMPACT is Phase 2 scale (multi-site, two-year duration), meaning Phase 3 initiation depends on these results, with realistic NDA submission 2029-2030. The urgency-evidence-access gap is widest for ibogaine: strongest evidence for the most acute crisis, but furthest from approval due to safety requirements that psilocybin's cleaner profile avoids.
