MedTrace Logo

A Study of Oral Ibogaine in Opioid Withdrawal

NCT05029401 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2024-08-06

No results posted yet for this study

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

Conditions

  • Opiate Withdrawal Syndrome

Interventions

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)

Sponsors & Collaborators

  • MAC Clinical Research

    collaborator OTHER

  • ERT: Clinical Trial Technology Solutions

    collaborator OTHER

  • Hammersmith Medicines Research

    collaborator OTHER

  • atai Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2024-01-16
Completion
2024-01-16

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05029401 on ClinicalTrials.gov