Neurofeedback in Individuals With Substance Use Disorders

March 12, 2024 updated by: Yale University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06512
        • Yale New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neurofeedback
Three imaging (fMRI) sessions of experimental feedback.
Device: 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.
Other: Control feedback
Three imaging (fMRI) sessions of control feedback.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid use
Time Frame: Baseline to one month post follow-up.
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
Time Frame: Baseline through follow-up (4 weeks).
This outcome will be assessed with functional magnetic resonance imaging (fMRI) scans.
Baseline through follow-up (4 weeks).
Opioid Craving
Time Frame: baseline to one month post follow-up (up to 2 months).
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
Time Frame: Baseline to one month post follow-up (up to 2 months).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Kathleen Garrison, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

March 15, 2023

Study Completion (Actual)

March 15, 2023

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (Actual)

December 5, 2019

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000025618
  • 1K01DA039299-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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