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A Study of Oral Ibogaine in Opioid Withdrawal

RecruitingRegisteredCTG

Phase I/2a randomized study (n=116) with single-ascending oral ibogaine doses (3–12 mg/kg) in healthy volunteers followed by a double-blind, placebo-controlled single-dose proof-of-concept in opioid-dependent patients for medically supervised opioid withdrawal.

Details

Stage 1 is a single-blind, within-subject assessment in healthy volunteers using placebo (Day 1) then ibogaine (Day 2) to evaluate safety, tolerability, PK and to establish an MTD/TTD via single-ascending doses (3, 6, 9, 12 mg/kg).

Stage 2 is a randomized, double-blind, parallel-group proof-of-concept in opioid-dependent patients comparing the selected DMX-1002 dose to matching placebo for safety, tolerability and efficacy during medically supervised opioid withdrawal.

Topics:Opioid Use Disorder (OUD)

Registry

Registry linkNCT05029401