Neurofeedback in Individuals With Substance Use Disorders

Not Applicable

Terminated

• Conditions: Opioid-Related Disorders
• Interventions: Device: Experimental feedback; Device: Control feedback; Device: fMRI

• Registration Number: NCT04188288
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Study Start: 2021-07-01
• Primary Completion: 2023-03-15
• Study Completion: 2023-03-15
• Status Verified: 2024-03
• Disposition First Submitted: 2024-03-12
• Last Update Submitted: 2024-03-12
• Disposition First Posted: 2024-03-26
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. non-methadone opioid positive urine screen (as assessed during standard treatment) or indicated via Utox or self-reported past-month opioid use at screening
2. Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for opioid use disorder, as assessed via structured clinical interview (SCID)
3. ≥3 months of methadone treatment

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Exclusion Criteria

1. 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.
2. Failure to pass a magnetic resonance imaging (MRI) screening
3. Having significant underlying medical conditions requiring medications.
4. Women who are pregnant or nursing
5. Baseline scanning with excessive motion based on frame to frame displacement

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neurofeedback	Experimental feedback	Three imaging (fMRI) sessions of experimental feedback.
Neurofeedback	fMRI	Three imaging (fMRI) sessions of experimental feedback.
Control feedback	Control feedback	Three imaging (fMRI) sessions of control feedback.
Control feedback	fMRI	Three imaging (fMRI) sessions of control feedback.

Primary Outcome Measures

Name	Time	Method
Opioid Use: Urine Tests	Baseline (week 1) to one month post follow-up (week 9)	Opioid use will be monitored by weekly urine test. This will be assessed as the percentage of negative tests.
Opioid Use: Timeline Followback Method (TLFB)	Baseline (week 1) to one month post follow-up (week 9)	Opioid use assessed using the timeline followback method (TLFB). TLFB asks subjects to estimate drug use during a specific time period in the past. Number of participants positive or negative for drug use.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Functional Connectivity Patterns in the Brain	Baseline (week 1) through follow up (week 5)	This outcome will be assessed with functional magnetic resonance imaging (fMRI) scans. Opioid abstinence network connectivity strength will be calculated during resting state (H2a). (Data was not able to be collected at MIDT and Stroop tasks as intended.) 0 represents no engagement of the opioid abstinence network. As as a novel brain network measure, there are no defined clinical cutoffs for functional connectivity. Reported is the Z-score Fisher transformed correlation coefficient.
Mean Opioid Craving Score	Baseline (week 1) to one month post follow-up (*week 9*)	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 0-30, with higher score indicating more craving.
Negative Affect Mean Score	Baseline (week 1) to one month post follow-up (week 9)	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 0-48, with higher scores indicating greater symptom severity.

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States