Mapping Ibogaine Neural Dynamics in Opioid Use Disorder

NCT07226570 | Recruiting

• 1 other identifier: 7038
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder (OUD)

Outcome Measures

Primary Outcomes (4)

• Change in Resting-State Functional Connectivity in Reward Circuitry

  Resting-state functional MRI will assess functional connectivity within reward circuitry, including the basal ganglia, nucleus accumbens, cingulate cortex, hippocampus, insula, and amygdala. Connectivity will be quantified using correlation coefficients between regional BOLD signals. Unit of Measure: Correlation coefficient (range: -1 to +1, where higher values indicate stronger positive connectivity)

  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

  Task-based functional MRI will measure blood-oxygen-level-dependent (BOLD) signal activation in reward-related brain regions (basal ganglia, nucleus accumbens, cingulate cortex, hippocampus, insula, and amygdala) while participants view opioid-related versus neutral images. Unit of Measure: Percent signal change in BOLD activation

  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

  Proton Magnetic Resonance Spectroscopy (1H-MRS) will measure glutamate+glutamine (Glx) concentration in the nucleus accumbens. Unit of Measure: Institutional units (ratio relative to creatine)

  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

  Proton Magnetic Resonance Spectroscopy (1H-MRS) will measure glutamate+glutamine (Glx) concentration in the anterior insula. Unit of Measure: Institutional units (ratio relative to creatine)

  Baseline (Visit 1; within 2 weeks of consent) and follow-up assessments approximately 4 to 6 weeks after baseline (Visits 4 and 5).

Secondary Outcomes (3)

• Change in Resting-State EEG Alpha Band Power

  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 Subjective Opiate Withdrawal Scale (SOWS) Score

  Baseline to end of study (8.5 months)

• Change in Opioid Craving Visual Analog Scale (OC-VAS) Score

  Baseline to end of study (8.5 months)

Study Arms (1)

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

Other: Observational study with MRI/EEG

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.

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

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults ages 21 to 70 with a confirmed diagnosis of moderate to severe opioid use disorder (OUD), defined as meeting four or more symptoms according to DSM-5 criteria. Participants must be independently scheduled to receive ibogaine treatment at a licensed clinic outside the United States.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Susan Samueli Integrative Health Institute, University of California, Irvine

Irvine, California, 92617, United States

RECRUITING

Related Links

• Drug Overdose Data

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Richard E Harris, PhD

  University of California, Irvine, Susan Samueli Integrative Health Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard E Harris, PhD

CONTACT

949-824-7000; richareh@hs.uci.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 22, 2025
• First Posted: November 10, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)