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Neurofeedback in Individuals With Substance Use Disorders

Primary Purpose

Opioid-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental feedback
Control feedback
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Related Disorders

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Yale New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Neurofeedback

Control feedback

Arm Description

Three imaging (fMRI) sessions of experimental feedback.

Three imaging (fMRI) sessions of control feedback.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

2. Functional connectivity patterns in the brain
This outcome will be assessed with functional magnetic resonance imaging (fMRI) scans.
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.
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.

Full Information

First Posted
December 3, 2019
Last Updated
August 14, 2023
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04188288
Brief Title
Neurofeedback in Individuals With Substance Use Disorders
Official Title
Neurofeedback in Individuals With Substance Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants will be blinded as to whether they are receiving experimental or control neurofeedback.
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurofeedback
Arm Type
Experimental
Arm Description
Three imaging (fMRI) sessions of experimental feedback.
Arm Title
Control feedback
Arm Type
Other
Arm Description
Three imaging (fMRI) sessions of control feedback.
Intervention Type
Device
Intervention Name(s)
Experimental feedback
Intervention Description
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
Intervention Name(s)
Control feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Opioid use
Description
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.
Time Frame
Baseline to one month post follow-up.
Secondary Outcome Measure Information:
Title
2. Functional connectivity patterns in the brain
Description
This outcome will be assessed with functional magnetic resonance imaging (fMRI) scans.
Time Frame
Baseline through follow-up (4 weeks).
Title
Opioid Craving
Description
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.
Time Frame
baseline to one month post follow-up (up to 2 months).
Title
Negative affect
Description
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.
Time Frame
Baseline to one month post follow-up (up to 2 months).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Garrison, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06512
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Neurofeedback in Individuals With Substance Use Disorders

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