Neurofeedback in Individuals With Substance Use Disorders

Opioid-Related Disorders Clinical Trial

Official title:

Neurofeedback in Individuals With Substance Use Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04188288
• Other study ID #: 2000025618
• Secondary ID: 1K01DA039299-01A
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to one month post follow-up.
Secondary	2. Functional connectivity patterns in the brain	This outcome will be assessed with functional magnetic resonance imaging (fMRI) scans.	Baseline through follow-up (4 weeks).
Secondary	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.	baseline to one month post follow-up (up to 2 months).
Secondary	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.	Baseline to one month post follow-up (up to 2 months).