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Safety and preliminary efficacy of ibogaine as a treatment for opioid use disorder

Award Number: UG3DA064414
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/15/2026
PERIOD OF PERFORMANCE END DATE: 05/31/2028

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Safety and preliminary efficacy of ibogaine as a treatment for opioid use disorder - Abstract The ongoing opioid crisis is a stark reminder of the dire consequences of persistent illicit opioid use. While medications for opioid use disorder (OUD, MOUD) are evidence-based treatments with robust empirical support in preventing overdoses and suppressing opioid use, a substantial proportion of individuals experience inadequate response, contributing to poor outcomes. Unfortunately, limited options exist for improving outcomes for those individuals. Ibogaine, an atypical psychedelic found in Tabernanthe Iboga, has long garnered interest as a potential treatment for OUD but adverse effects (AE), particularly on QTc prolongation, have hampered its development. However, there are numerous examples of commonly used treatments despite risks for QTc prolongation—methadone is a gold-standard OUD treatment due to the robust empirical support in improving outcomes despite known to prolong QTc; sotalol and dofetilide, commonly used class III antiarrhythmic drugs, require an inpatient hospitalization to initiate treatment due to significant risks of QTc prolongation. With the growing understanding of ibogaine’s pharmacology, the cardiac risks may be mitigated similarly to how they are managed with methadone, sotalol or dofetilide—implement stringent inclusion and exclusion criteria, conduct the treatment during an inpatient hospitalization, and closely monitor ECG and discontinue if QTc>500ms. While research to identify ibogaine analogs with less cardiotoxicity remains important, there is considerably more human data pointing to ibogaine’s efficacy in improving OUD outcomes. The justification for using ibogaine as a therapeutic intervention hinges on its efficacy, but we are not aware of any rigorous research currently being planned under an FDA Investigational New Drug (IND) to study ibogaine’s safety and efficacy as a treatment for OUD. To fill this gap, we propose an exploratory/developmental phased trial by first securing an FDA research IND approval without any clinical hold imposed during the UG3 phase. After approval, we will conduct a phase 1 single ascending dose (SAD) study using a 3+3 design with healthy volunteers to identify the maximum tolerated dose (MTD) using GMP ibogaine. Dose limiting toxicity will be defined as QTc>500ms or an absolute increase of QTc by 20%. Results will inform the design of a phase 2a trial in the UH3 phase to determine the safety and preliminary efficacy of ibogaine in improving OUD-related outcomes among individuals who are not adequately responding to buprenorphine treatment. The trial will minimize bias by utilizing a dose-comparison concurrent control design, blinded assessors, ibogaine-naïve participants, account for treatment expectancy, and assess blinding by participants and therapists. Our multidisciplinary team has the necessary expertise to study ibogaine’s safety and preliminary efficacy, as well as. If successful, the results will lay the foundation for the design and execution of an adequately powered randomized trial to further evaluate the safety and efficacy of ibogaine to treat OUD for those who are not adequately responding to existing treatments.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $2,288,947 )
2026	2026	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Drug Use and Addiction Research Programs	001	1	7/6/2026	NEW	$0
2026	2026	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Drug Use and Addiction Research Programs	000	1	6/11/2026	NEW	$2,288,947
														Subtotal = $2,288,947

Grand Total All Awards = $2,288,947

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Safety and preliminary efficacy of ibogaine as a treatment for opioid use disorder

Award Number: UG3DA064414

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/15/2026

PERIOD OF PERFORMANCE END DATE: 05/31/2028

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