Mapping Ibogaine Neural Dynamics in Opioid Use Disorder
ConditionOpioid Use Disorder (OUD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-70
SponsorUniversity of California, Irvine
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational study with MRI/EEG
Other interventionParticipants 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Adults (21-65) with Opioid Use Disorder Receiving Ibogaine1 intervention
Trial outcomes
Primary outcomes
1
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)
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).2
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
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).3
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)
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).4
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)
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).Secondary outcomes
1
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)
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).2
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)
Time frame
Baseline to end of study (8.5 months)3
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)
Time frame
Baseline to end of study (8.5 months)Sponsors and contacts
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Source ClinicalTrials.gov