Neurofeedback in Individuals With Substance Use Disorders

Yale University

Status: Terminated

Conditions: Opioid-Related Disorders

Treatments: Device: fMRI; Device: Control feedback; Device: Experimental feedback

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04188288

2000025618

1K01DA039299-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Neurofeedback

Experimental group

Description:

Three imaging (fMRI) sessions of experimental feedback.

Treatment:

Device: Experimental feedback

Device: fMRI

Control feedback

Other group

Description:

Three imaging (fMRI) sessions of control feedback.

Treatment:

Device: Control feedback

Device: fMRI