A Study of Oral Ibogaine in Opioid Withdrawal
- Registration Number
- NCT05029401
- Lead Sponsor
- atai Therapeutics, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single dose IMP (DMX-1002) Placebo Stage 1 (single blind, placebo controlled): initial dose of placebo, followed by treatment at one of 4 ascending dose levels of IMP (3, 6, 9 or 12 mg/kg) Stage 2 (blinded): MTD/TTD established in Stage 1 vs placebo (proof of concept) Matching Placebo Placebo Placebo using capsules identical to the IMP (DMX-1002) Single dose IMP (DMX-1002) DMX-1002 Stage 1 (single blind, placebo controlled): initial dose of placebo, followed by treatment at one of 4 ascending dose levels of IMP (3, 6, 9 or 12 mg/kg) Stage 2 (blinded): MTD/TTD established in Stage 1 vs placebo (proof of concept)
- Primary Outcome Measures
Name Time Method Stage 2 - Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) average score from Day 2 to Day 6 Day 2 to Day 6 The SOWS-Gossop is a 10-item questionnaire to evaluate opioid withdrawal symptom severity. Each item is scored on a 4-point scale. Higher scores indicate greater severity (total score range 0-40).
- Secondary Outcome Measures
Name Time Method Stage 2 - Proportion of subjects requiring clonidine for relief of withdrawal symptoms up to Day 6 Day 1 to Day 6 Proportion of subjects requiring clonidine for relief of withdrawal symptoms
Stage 2 - Clinician-rated daily Clinical Global Impression - Improvement (CGI-I) score from Day 2 to Day 6 Day 2 to Day 6 The CGI-I is a 7-point scale that requires the clinician to assess how much the subject's condition has improved or worsened from baseline. The ratings are: 1 - very much improved; 2 - much improved; 3 - minimally improved; 4 - no change; 5 - minimally worse; 6 - much worse; 7 - very much worse.
Stage 2 - Daily subject-rated Visual Analog Scale for Efficacy (VAS-E) score from Day 2 to Day 6 and at Day 30 Day 2 to Day 6 and at Day 30 The VAS-E is a scale to quantify the state of craving a subject experienced in the previous 24 hours. The scale size is 100 mm, anchored on the left by "no craving at all" and anchored on the right by "strongest craving ever."
Stage 2 - Hamilton Depression Rating Scale (HAM-D) score at Day 6 and Day 30 Day 6 and Day 30 The HAM-D is used to determine a subject's level of depression. The study uses the original 17-item scale. Higer scores indicate greater severity (total score range 0-52).
Stage 2 - Subject completion status at Day 6 (key secondary endpoint) Day 6 Proportion of subjects who received study medication and completed the SOWS-Gossop assessment on Day 6
Stage 2 - Objective Opiate Withdrawal Scale of Handelsman (OOWS Handelsman) average score from Day 2 to Day 6 Day 2 to Day 6 The OOWS-Handelsman is an interview and observation tool for assessing opioid withdrawal signs and symptoms. It contains 13 physically observable signs, rated present or absent, based on a timed period of observation of the subject by a rater. Higher scores indicate greater severity (total score range 0-13).
Stage 2 - Subject completion status at Day 30 Day 30 Proportion of subjects who received study medication and completed the SOWS-Gossop assessment on Day 30
Stage 2 - Time to drop-out through Day 30 Day 1 to Day 30 Time to drop-out
Trial Locations
- Locations (2)
Hammersmith Medicines Research (HMR) Limited
🇬🇧London, United Kingdom
MAC Clinical Research Manchester (Early Phase Unit), Neuroscience Centre of Excellence
🇬🇧Manchester, Greater Mancherster, United Kingdom