Neurofeedback in Individuals With Substance Use Disorders

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-03-15

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.

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Detailed Description

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Conditions

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Opioid-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants will be blinded as to whether they are receiving experimental or control neurofeedback.

Study Groups

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Neurofeedback

Three imaging (fMRI) sessions of experimental feedback.

Group Type EXPERIMENTAL

Experimental feedback

Intervention Type DEVICE

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.

fMRI

Intervention Type DEVICE

fMRI will be used to assess brain activity

Control feedback

Three imaging (fMRI) sessions of control feedback.

Group Type OTHER

Control feedback

Intervention Type DEVICE

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.

fMRI

Intervention Type DEVICE

fMRI will be used to assess brain activity

Interventions

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Experimental feedback

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.

Intervention Type DEVICE

Control feedback

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.

Intervention Type DEVICE

fMRI

fMRI will be used to assess brain activity

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No