A Phase I/2a Study of Oral Ibogaine in Opioid Users

• Research type

  Research Study

• Full title

  A Phase 1/2a Study of Single-Dose Oral Ibogaine to Determine the Maximum Tolerated Dose (MTD) or Treat-to-Target Dose (TTD) in Recreational Opioid Users (Stage 1) and to Evaluate the Efficacy and Safety of the MTD/TTD in Opioid-Dependent Subjects Seeking Medically Supervised Opioid Withdrawal (Stage 2)

• IRAS ID

  291814

• Contact name

  Pui Man Leung

• Contact email

  puimanleung@macplc.com

• Sponsor organisation

  atai Therapeutics, Inc

• Eudract number

  2020-005316-22

• Clinicaltrials.gov Identifier

  NCT05029401

• Duration of Study in the UK

  0 years, 5 months, 26 days

• Research summary

  The purpose of this study is to test a drug called ibogaine (the ‘study drug’) that is being developed for the treatment of acute opioid withdrawal symptoms and also to facilitate abrupt discontinuation of opioid use. Treatment for opioid dependence consists of treatment with medication, behavioural changes and interventions focused on psychological or social factors. The aim is to reduce or stop opioid use, prevent potential future harm associated with opioid use, and improve the quality of life and well being of opioid-dependent patients.

  Medically managed withdrawal (detoxification) may be a necessary first step in recovery for patients who are physically dependent on opioids. Withdrawal symptoms arising from stopping opioid use are managed by gradually reducing the dose of opioids and by providing non-narcotic medications that relieve symptoms, or by a combination of the two.

  The main aims of this study are:
  • To assess the safety and tolerability of the study drug
  • To see how the body absorbs and removes the study drug

  This study is divided into 2 parts: Stage 1 consists of a single dose administration of the study drug in non-dependent recreational opioid users with hallucinogen experience. Stage 2 consists of a single dose administration of the study drug or placebo in opioid-dependent patients with hallucinogen experience who are seeking medically supervised opioid withdrawal. Participation is only permitted in one part of the study.

  The study aims to recruit 110 participants in total and will be run in a Phase I Clinical Research Unit in the United Kingdom (UK). Stage 2 will be run at NHS sites within the UK. A separate ethics application will be made in relation to this. Healthy males and females (either recreational opioid users, or dependent opioid users) between the ages of 21 and 55, who fit all of the eligibility criteria, will be recruited.

• REC name

  Wales REC 1

• REC reference

  20/WA/0324

• Date of REC Opinion

  8 Jan 2021

• REC opinion

  Further Information Favourable Opinion