Mapping Ibogaine Neural Dynamics in Opioid Use Disorder

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, Irvine
Study ID
NCT07226570
Status
Recruiting
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Conditions

  • Opioid Use Disorder (OUD)

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Observational study with MRI/EEG — OTHER
    Participants will independently undergo ibogaine treatment at a licensed clinic outside the United States. The UCI research team will not provide the ibogaine treatment but will conduct observational imaging and qualitative assessments before and after. These include MRI and MRS scans to measure brain activity and chemistry, EEG recordings of brain wave activity, urine toxicology and pregnancy tests, and self-report questionnaires on craving, withdrawal, mood, pain, anxiety, and quality of life.

Study Details

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.

Key Dates

Start date
Sep 8, 2025
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Adults (21-65) with Opioid Use Disorder Receiving Ibogaine

Primary Outcome Measure

Change in Resting-State Functional Connectivity in Reward Circuitry [ Time Frame: Baseline (Visit 1; within 2 weeks of consent) and follow-up assessments approximately 4 to 6 weeks after baseline (Visits 4 and 5). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Susan Samueli Integrative Health Institute, University of California, IrvineIrvineCalifornia92617
Charlotte J Lynskey, BA
[email protected]
(949) 824-7000
Ahmad Mahan
[email protected]
(949) 824-7000
Richard E Harris, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Susan Samueli Integrative Health Institute, University of California, Irvine· Irvine, CA

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