How ibogaine changes brain activity in opioid use disorder.

Central Neural Actions of Ibogaine in Opioid Use Disorder (OUD)

This study will test whether ibogaine changes brain activity and symptoms in adults with moderate-to-severe opioid use disorder who are already planning legal treatment.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 21 Years to 70 Years
• Sex: All
• Sponsor: University of California, Irvine (Academic / other)
• Locations: 1 site (Irvine, California)
• Trial ID: NCT07226570 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 21–65 with confirmed moderate-to-severe OUD (≥4 DSM-5 symptoms) who are independently scheduled for legal ibogaine treatment at Ambio Life Sciences in Tijuana and can attend three MRI/EEG visits at UC Irvine and provide urine samples and informed consent.

Not a fit: People with MRI contraindications, recent psychedelic use, or diagnoses such as schizophrenia, bipolar I/II, or borderline personality disorder, as well as those unable to travel to UC Irvine or not actually receiving ibogaine, are unlikely to be eligible or to gain direct benefit from participation.

Why it matters

Potential benefit: If successful, the results could identify brain changes tied to reduced opioid craving and withdrawal and help guide future treatments and research.

How similar studies have performed: Small observational reports and case series suggest ibogaine can reduce opioid cravings and withdrawal, but controlled clinical trials and detailed neural-imaging data are limited, so the neural-mapping approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Adults aged 21-65 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 this trial is running

Irvine, California

• 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

Conditions Opioid Use Disorder