Recruiting

Ibogaine

Sponsor:

UCLA

Code:

NCT07226570

Conditions

Opioid Use Disorder (OUD)

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

Observational study with MRI/EEG

Study Details

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)

Study ID

NCT07226570

Start date

Sep 8, 2025

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Observational study with MRI/EEG

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.

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). ]
  • Change in BOLD Activation to Drug Cues During Task-Based fMRI [ 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). ]
  • Change in Glutamate+Glutamine Concentration in Nucleus Accumbens [ 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). ]
  • Change in Glutamate+Glutamine Concentration in Anterior Insula [ 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 and Locations

Central contacts

Richard E Harris, PhD

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

Locations

Susan Samueli Integrative Health Institute, University of California, Irvine

Recruiting

Irvine, California, United States, 92617

Contacts

Charlotte J Lynskey, BA

(949) 824-7000clynskey@hs.uci.edu

Ahmad Mahan

(949) 824-7000amahan1@hs.uci.edu

Principal Investigator:

Richard E Harris, PhD

More Information

Sponsor

University of California, Irvine

Last update posted

May 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-05-18.