Neurofeedback in Individuals With Substance Use Disorders

Study Overview
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Brief Summary
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The aim of this study is to train individuals with opioid use disorder to control their brain activity in a way that has been associated with their symptoms. Participants in the experimental group will be given direct feedback regarding their brain activity while they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to learn to control their brain activity during these feedback sessions. A separate group of participants will be given a control form of feedback that we do not believe can have clinical benefits. Our primary hypothesis is that the neurofeedback training will reduce opioid use and clinical features of opioid use disorder more than the control feedback.

Official Title
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Neurofeedback in Individuals With Substance Use Disorders

Conditions
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Opioid-Related Disorders

Intervention / Treatment
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* Device: Experimental feedback
* Device: Control feedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-methadone opioid positive urine screen (as assessed during standard treatment) or indicated via Utox or self-reported past-month opioid use at screening Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for opioid use disorder, as assessed via structured clinical interview (SCID) ≥3 months of methadone treatment Exclusion Criteria: Having any current neurologic or psychiatric disorders including current moderate to severe other DSM-5 substance use disorders with the exceptions of opioids, cocaine, tobacco and cannabis, as assessed using the SCID. Failure to pass a magnetic resonance imaging (MRI) screening Having significant underlying medical conditions requiring medications. Women who are pregnant or nursing Baseline scanning with excessive motion based on frame to frame displacement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurofeedback<br>Three imaging (fMRI) sessions of experimental feedback. | Device: Experimental feedback<br>* Participants provided with feedback of target brain activation patterns (for example, in the form of a line graph) and will be instructed to try to make the line go up or down.<br>|
| Other: Control feedback<br>Three imaging (fMRI) sessions of control feedback. | Device: Control feedback<br>* Participants provided with control type of feedback (for example, in the form of a line graph) and will be instructed to try to make the line go up or down.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use | Opioid use will be monitored by weekly urine test and the timeline followback method (TLFB). TLFB asks subjects to estimate drug use during a specific time period in the past. | Baseline to one month post follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2. Functional connectivity patterns in the brain | This outcome will be assessed with functional magnetic resonance imaging (fMRI) scans. | Baseline through follow-up (4 weeks). | 
| Opioid Craving | This outcome will be measured with the Opioid Craving Scale, a 3-item measure of craving that uses a 0-10 analog scale. Total possible score is 30, with higher score indicating more craving. | baseline to one month post follow-up (up to 2 months). | 
| Negative affect | This outcome will be measured by the Quick Inventory of Depressive Symptomatology. This is a 16-item measure, using a 0-3 scale for each item. Total possible score is 48, with higher scores indicating greater symptom severity. | Baseline to one month post follow-up (up to 2 months). |