drugset / Trial / NCT05029401
A Study of Oral Ibogaine in Opioid Withdrawal
Phase 1/2
Completed
116 enrolled
atai Therapeutics, Inc.
ERT: Clinical Trial Technology Solutions · collabHammersmith Medicines Research · collabMAC Clinical Research · collab
RandomizedParallel-groupDouble-blindTreatment
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
Timeline
- Start
- 2021-04-01
- Primary completion
- 2024-01-16
- Completion
- 2024-01-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibogaine | Small molecule | 3 mg/kg | Oral |
| Subject | Ibogaine | Small molecule | 6 mg/kg | Oral |
| Subject | Ibogaine | Small molecule | 9 mg/kg | Oral |
| Subject | Ibogaine | Small molecule | 12 mg/kg | Oral |