RecruitingN/A

Mapping Ibogaine Neural Dynamics in Opioid Use Disorder

NCT07226570 · MIND-OUD · University of California, Irvine

Recruiting

Status

Accepting participants

Not applicable

Phase

Target enrolment

Study sites

1 US states

What it is testing

Summary

This study aims to understand how ibogaine treatment may change brain activity and symptoms in people with moderate-severe opioid use disorder (OUD), as defined by the DSM-5. Ibogaine is a plant-derived compound that some studies suggest can reduce opioid cravings and withdrawal. Participants in this study will already be independently scheduled to receive legal ibogaine treatment at a licensed clinic outside of the U.S. The University of California, Irvine (UCI) research team will not provide the treatment but will conduct brain imaging, administer psychometric questionnaires, and obtain urine samples throughout the course of this study. UCI does not sponsor or financially support the ibogaine treatment in any way; all treatment costs are the sole responsibility of the participant. The main goal is to see if ibogaine changes brain function as assessed with magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS), and electroencephalography (EEG). MRI/MRS will measure brain activity when participants view opioid-related images, brain connectivity at rest, and levels of brain chemicals involved in craving and substance use. EEG will measure brain wave activity. MRI/MRS/EEG will be administered across 3 study time points. In addition, participants will complete psychometric surveys related to opioid craving, withdrawal symptoms, mood, anxiety, pain, and quality of life, along with urine tests to monitor substance use and screen for pregnancy. The investigators hypothesize that after ibogaine treatment, participants will show reduced brain responses to opioid cues, changes in brain connectivity and chemistry, and improvements in self-reported cravings and other symptoms. This information may help researchers better understand how ibogaine works in the brain and whether it could play a role in future treatments for OUD.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Change in Resting-State Functional Connectivity in Reward Circuitry
Measured over Baseline (Visit 1; within 2 weeks of consent) and follow-up assessments approximately 4 to 6 weeks after baseline (Visits 4 and 5).
Change in BOLD Activation to Drug Cues During Task-Based fMRI
Measured over Baseline (Visit 1; within 2 weeks of consent) and follow-up assessments approximately 4 to 6 weeks after baseline (Visits 4 and 5).
Change in Glutamate+Glutamine Concentration in Nucleus Accumbens
Measured over Baseline (Visit 1; within 2 weeks of consent) and follow-up assessments approximately 4 to 6 weeks after baseline (Visits 4 and 5).
Change in Glutamate+Glutamine Concentration in Anterior Insula
Measured over Baseline (Visit 1; within 2 weeks of consent) and follow-up assessments approximately 4 to 6 weeks after baseline (Visits 4 and 5).

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 70 Years

Ages

All

Sex

Not accepted

Healthy volunteers

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

1 study site

Facility	City	Region	Country
Susan Samueli Integrative Health Institute, University of California, Irvine	Irvine	California	United States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT07226570 on ClinicalTrials.gov →

Last updated in the registry 2026-05-18. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ibogaine

Indication

Opioid Use Disorder17

Recruiting in

California115