NCT05029401

A Study of Oral Ibogaine in Opioid Withdrawal

Ibogaine to Determine Maximum Tolerated Dose (MTD) or Treat-to-Target Dose (TTD) for the Evaluation of Efficacy and Safety

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: atai Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Study DMX-IB 201 is a Phase 1/2a study of ibogaine consisting of an initial single ascending dose escalation stage to determine the maximum tolerated dose (MTD) or treat-to-target dose (TTD) in healthy volunteers, followed by a randomized, double-blind, placebo-controlled proof of concept stage to demonstrate the efficacy, safety and tolerability of the selected dose in opioid-dependent patients who seek medically supervised opioid withdrawal

Detailed description

Detailed description restricted as elements of this trial are part of a Phase 1 clinical trial.

Conditions

• Opiate Withdrawal Syndrome

Interventions

Type	Name	Description
DRUG	DMX-1002	Investigation of the safety, tolerability and pharmacokinetics (PK) in healthy volunteers (Stage 1 - single blind), and the efficacy, safety, tolerability and PK in opioid-dependent patients (Stage 2 - double blind)
DRUG	Placebo	Matching placebo to the IMP (DMX-1002)

Timeline

• Start date: 2021-04-01
• Primary completion: 2024-01-16
• Completion: 2024-01-16
• First posted: 2021-08-31
• Last updated: 2024-08-06

Locations

2 sites across 1 country: United Kingdom