NCT07226570 Mapping Ibogaine Neural Dynamics in Opioid Use Disorder
| NCT ID | NCT07226570 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Irvine |
| Condition | Opioid Use Disorder (OUD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-09-08 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-09-08 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Richard E Harris, PhD
PRINCIPAL INVESTIGATOR
University of California, Irvine, Susan Samueli Integrative Health Institute
Frequently Asked Questions
Who can join the NCT07226570 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 70 Years, studying Opioid Use Disorder (OUD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07226570 currently recruiting?
Yes, NCT07226570 is actively recruiting participants. Contact the research team at richareh@hs.uci.edu for enrollment information.
Where is the NCT07226570 trial being conducted?
This trial is being conducted at Irvine, United States.
Who is sponsoring the NCT07226570 clinical trial?
NCT07226570 is sponsored by University of California, Irvine. The principal investigator is Richard E Harris, PhD at University of California, Irvine, Susan Samueli Integrative Health Institute. The trial plans to enroll 20 participants.