How ibogaine changes brain activity in opioid use disorder.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will enroll adults with moderate-to-severe opioid use disorder who are independently scheduled to receive legal ibogaine treatment at a licensed clinic in Tijuana. Researchers at UC Irvine will collect brain imaging (task and resting-state fMRI), magnetic resonance spectroscopy (MRS), and electroencephalography (EEG) at baseline, about 3–5 days after treatment, and at one month, along with psychometric questionnaires and urine samples. The team will compare pre- and post-treatment brain activation, connectivity, and metabolite levels (including Glx in key reward regions) and explore links between neural changes and craving or withdrawal scores. UC Irvine does not provide or fund the ibogaine treatment itself and only conducts the imaging and assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 21-70 with confirmed moderate to severe OUD as assessed by equal or greater than 4 symptoms using DSM-5 criteria.
* Independently scheduled to receive ibogaine treatment at Ambio Life Sciences in Tijuana, Mexico.
* Able to undergo MRI and EEG procedures at UC Irvine at Visit 1 (baseline), Visit 4, and Visit 5, totaling three sessions.
* Able to complete psychometric surveys at each study time point.
* Able to provide urine samples at all three scanning sessions at UCI.
* Able to provide urine samples at a local external lab for 3- and 6-month follow-ups.
* Capable of giving written informed consent.
* Proficient ability to speak, read, and write in English.

Exclusion Criteria:

* Presence of known past procedures, devices in the body, claustrophobia, or other contraindications for MRI.
* Use of any psychedelic substances within 3 months prior to screening.
* Diagnosis of schizophrenia, bipolar disorder (type I or II), or borderline personality disorder.
* Use of ibogaine within 6 months prior to screening.
* Pregnant or nursing. Participants who become pregnant during the study will be withdrawn from further participation.
* Diagnosis of epilepsy or history of seizures.
* Other contraindications to MRI/EEG methods. These may include but are not limited to: brain surgical clips and surgical staples, metal implants in the brain, and certain metallic dental material.
* Inability to complete MRI/EEG sessions or follow-up visits.
* Inability or unwillingness of an individual to give written informed consent.

Note: UCI does not sponsor or financially support the ibogaine treatment in any way; all treatment costs are the sole responsibility of the participant.

Where it's running

• Susan Samueli Integrative Health Institute, University of California, Irvine
  Irvine, California, United States Recruiting

Study contacts

• Principal investigator: Richard E Harris, PhD — University of California, Irvine, Susan Samueli Integrative Health Institute
• Study coordinator: Richard E Harris, PhD
• Email: richareh@hs.uci.edu
• Phone: 949-824-7000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mindfulness Text Messages to Support Medication Adherence and Pain Management

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• Text reminders and mindfulness messages to support people taking opioid medications

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• Personalized adaptive deep brain stimulation for severe opioid use disorder

  This study will test whether personalized deep brain stimulation guided by invasive brain mapping is safe and can reduce cravings and opioid use in adults with severe, treatment-resistant opioid use disorder.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07214467

• Autonomous nurse-led methadone delivery

  This test sees if allowing nurses to manage and give methadone helps people starting treatment for opioid use disorder.

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• Sparrow Link device to help with opioid withdrawal in hospitalized adults with OUD

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• Cannabidiol added to methadone or buprenorphine for opioid recovery

  This trial will test whether adding cannabidiol (CBD) to methadone or buprenorphine helps people with opioid use disorder reduce craving and stop using illicit opioids.

  Recruiting at 2 sites Phase 3 Icahn School of Medicine at Mount Sinai · New York, New York and 1 other locations · NCT06940674

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.