Opioid Use Disorder (OUD)MIND-OUDNCT07226570
Mapping Ibogaine Neural Dynamics in Opioid Use Disorder
An observational study of Opioid Use Disorder (OUD), run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Opioid Use Disorder (OUD)
- What is being tested?
- Observational study with MRI/EEG
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Susan Samueli Integrative Health Institute, University of California, Irvine
Irvine, California, 92617
Charlotte J Lynskey, BA, (949) 824-7000, clynskey@hs.uci.edu
Ahmad Mahan, (949) 824-7000, amahan1@hs.uci.edu
About this study
Official title: Central Neural Actions of Ibogaine in Opioid Use Disorder (OUD)
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.
Read the detailed description
Primary Hypothesis:
3-5 days and 1-month after ibogaine treatment (compared to baseline), participants will show reduced brain responses to opioid-related images on task fMRI and reduced resting-state connectivity within reward circuitry. The brain areas expected to be affected include the basal ganglia, cingulate cortex, hippocampus, and amygdala. Post-ibogaine spectroscopy will also show lower glutamate + glutamine (Glx) levels within the insula and nucleus accumbens.
Exploratory Hypotheses:
The magnitude of MRI/MRS changes (including activation/connectivity in the cingulate, hippocampus, and amygdala) will correlate with improvements in opioid craving and related symptoms measured by validated questionnaires (e.g., VAS craving, SOWS, CEQ).
EEG will show relative decreases in alpha power, relative decreases in gamma power, and decreases in frontal alpha frequency and signal complexity, which will track with reductions in craving and withdrawal.
- Conditions
- Opioid Use Disorder (OUD)
- Being tested
- Observational study with MRI/EEG
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study with MRI/EEGOther
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 group | Role | What they receive |
|---|---|---|
| Adults (21-65) with Opioid Use Disorder Receiving Ibogaine | Not described Receives: Other: Observational study with MRI/EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Electroencephalography (EEG) will be recorded using a 64-electrode BrainVision system during resting-state conditions. Alpha band power (8-12 Hz) will be quantified from averaged spectral analysis.
Unit of Measure: Microvolts squared (μV²)
Measured: 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
The Subjective Opiate Withdrawal Scale (SOWS) is a self-report questionnaire, typically with 16 items, designed to measure the severity of common opiate withdrawal symptoms experienced by individuals. Each item asks the respondent to rate the severity of a specific withdrawal symptom on a scale, allowing for a quantified subjective experience of withdrawal.
Unit of Measure: Score on a scale (0-64, higher = greater withdrawal intensity)
Measured: Baseline to end of study (8.5 months)
Change in Opioid Craving Visual Analog Scale (OC-VAS) Score
The Opioid Craving Visual Analog Scale is a self-report measure used to assess the subjective intensity of opioid craving. Participants indicate their current level of craving by marking a point along a 100 mm line anchored at each end with "no craving" (0) and "extreme craving" (100). The distance from the "no craving" anchor to the participant's mark represents the craving score. Higher scores indicate greater craving intensity (i.e., worse outcome).
Unit of Measure: Score on a scale (0-100, higher = worse outcome)
Measured: Baseline to end of study (8.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start8 Sep 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use Disorder (OUD)Studies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Edmund Harris, University of California, Irvine
- Investigators
- Richard E Harris, PhD, Principal investigator, University of California, Irvine, Susan Samueli Integrative Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226570
- Sponsor's protocol ID
- 7038
- Acronym
- MIND-OUD
- Status last verified
- May 2026
- First submitted
- 22 Oct 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Neural Actions of Ibogaine in Opioid Use Disorder (OUD)
- ClinicalTrials.gov ID
- NCT07226570
- Acronym / sponsor ID
- MIND-OUD / 7038
- Conditions
- Opioid Use Disorder (OUD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Hypothesis:
3-5 days and 1-month after ibogaine treatment (compared to baseline), participants will show reduced brain responses to opioid-related images on task fMRI and reduced resting-state connectivity within reward circuitry. The brain areas expected to be affected include the basal ganglia, cingulate cortex, hippocampus, and amygdala. Post-ibogaine spectroscopy will also show lower glutamate + glutamine (Glx) levels within the insula and nucleus accumbens.
Exploratory Hypotheses:
The magnitude of MRI/MRS changes (including activation/connectivity in the cingulate, hippocampus, and amygdala) will correlate with improvements in opioid craving and related symptoms measured by validated questionnaires (e.g., VAS craving, SOWS, CEQ).
EEG will show relative decreases in alpha power, relative decreases in gamma power, and decreases in frontal alpha frequency and signal complexity, which will track with reductions in craving and withdrawal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults (21-65) with Opioid Use Disorder Receiving Ibogaine | – | Other: Observational study with MRI/EEG |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study with MRI/EEGParticipants 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. | Other | Adults (21-65) with Opioid Use Disorder Receiving Ibogaine |
Primary outcome
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).
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)
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).
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
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).
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)
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).
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)
3 secondary outcomes
Change in Resting-State EEG Alpha Band Power
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 Subjective Opiate Withdrawal Scale (SOWS) Score
Time frame: Baseline to end of study (8.5 months)
Change in Opioid Craving Visual Analog Scale (OC-VAS) Score
Time frame: Baseline to end of study (8.5 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard E Harris, PhD principal investigator
University of California, Irvine, Susan Samueli Integrative Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder (OUD), run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard E Harris, PhD (949-824-7000, richareh@hs.uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.