Status and phase
Conditions
Treatments
About
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
Full description
Detailed description restricted as elements of this trial are part of a Phase 1 clinical trial.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Important Inclusion Criteria for both Stages 1 and 2:
Important Exclusion Criteria for both Stages 1 and 2:
Primary purpose
Allocation
Interventional model
Masking
116 participants in 2 patient groups, including a placebo group
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Central trial contact
Project Manager; D Mash, PhD
Data sourced from clinicaltrials.gov
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