Neurofeedback in Individuals With Substance Use Disorders

NCT04188288 | Terminated Results

• 2 other identifiers: 20000256181K01DA039299-01A1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-Related Disorders

Outcome Measures

Primary Outcomes (2)

• Opioid Use: Urine Tests

  Opioid use will be monitored by weekly urine test. This will be assessed as the percentage of negative tests.

  Baseline (week 1) to one month post follow-up (week 9)

• Opioid Use: Timeline Followback Method (TLFB)

  Opioid use assessed using the timeline followback method (TLFB). TLFB asks subjects to estimate drug use during a specific time period in the past. Number of participants positive or negative for drug use.

  Baseline (week 1) to one month post follow-up (week 9)

Secondary Outcomes (3)

• Mean Change in Functional Connectivity Patterns in the Brain

  Baseline (week 1) through follow up (week 5)

• Mean Opioid Craving Score

  Baseline (week 1) to one month post follow-up (*week 9*)

• Negative Affect Mean Score

  Baseline (week 1) to one month post follow-up (week 9)

Study Arms (2)

Neurofeedback

EXPERIMENTAL

Three imaging (fMRI) sessions of experimental feedback.

Device: Experimental feedback; Device: fMRI

Control feedback

OTHER

Three imaging (fMRI) sessions of control feedback.

Device: Control feedback; Device: fMRI

Interventions

Experimental feedback 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.

Neurofeedback

Control feedback 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.

Control feedback

fMRI DEVICE

fMRI will be used to assess brain activity

Control feedback; Neurofeedback

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Kathleen Garrison, PhD
• Organization: Yale University

kathleen.garrison@yale.edu

203-737-6232

Study Officials

• Kathleen Garrison, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded as to whether they are receiving experimental or control neurofeedback.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: July 1, 2021
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: September 25, 2024
• Results First Posted: September 25, 2024

Record last verified: 2024-09

Locations

US (1)