Sponsors: DemeRx IB, Inc. (atai Life Sciences); MAC Clinical Research; ERT: Clinical Trial Technology Solutions
Study DMX-IB 201 is a phase 1/2a clinical trial of ibogaine HCl (DMX-1002) for the treatment of opioid use disorder (OUD) which is underway at the Manchester clinical unit of MAC Clinical Research (MAC) in the UK. The trial consisting of 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.
In previously published non-controlled studies, ibogaine has demonstrated rapid and sustained efficacy in treating OUD and has the potential to be a disease modifying treatment for this vulnerable patient population seeking to end their intractable cycle of drug dependence.
“By launching the Phase1/2a trial, we look forward to bringing important data from carefully designed, controlled studies to the existing literature on ibogaine, a compound with substantial history,” said Dr. Deborah Mash, CEO and President of DemeRx. “We are hopeful that this early trial can begin to establish a safe and efficacious profile for Ibogaine, so that we can potentially offer a new option for patients seeking to break free from OUD who have far too few options.”
Dosing of the oral formulation of ibogaine began on 21st September 2021 & is expected to continue until early 2022.
Information retrieved from clinicaltrials.gov & atai Life Sciences
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