Optimization of NIBS for Treatment of Addiction

March 3, 2026 updated by: Case Western Reserve University

Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction

The purpose of this study is to assess the effects of transcranial Direct Current Stimulation (tDCS) applied in conjunction with Transcranial Ultrasound (TUS) for the treatment of addiction in opiate use disorder with chronic pain. The investigators hypothesize that there will be a decrease in drug use and improved psychosocial assessments with active stimulation, when compared to sham stimulation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

126

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 Contact Backup

Study Locations

  • United States
    • Illinois
      • Hinsdale, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Health/ University of Illinois at Chicago
        • Contact:
        • Principal Investigator:
          • Ciro Ramos Estebanez, MD, PhD
        • Contact:
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Recruiting
        • Spaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center
        • Contact:
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106-1716
        • Recruiting
        • University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit
        • Contact:
        • Contact:

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

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

Participants must meet all of the following:

  • Provide informed consent
  • Age 18-85 years
  • Diagnosis of opioid use disorder (DSM-5) with ongoing non-prescription opioid use confirmed by self-report and urine toxicology
  • Report current opioid craving
  • Enrolled in a certified Opioid Treatment Program and receiving methadone maintenance treatment
  • Stable methadone dose prior to enrollment
  • Reside locally with no plans to relocate during the study Exclusion Criteria

Participants will be excluded if they:

  • Are pregnant
  • Have frequent illicit stimulant use or acute stimulant intoxication
  • Are using substances or medications that may interfere with study assessments (e.g., stimulant medications, buprenorphine-based therapies, naltrexone)
  • Have significant neurological conditions (e.g., stroke, epilepsy, brain tumor), abnormal EEG findings, history of brain surgery, significant head injury, or unexplained syncope
  • Have contraindications to noninvasive brain stimulation (e.g., metal in the head, implanted brain devices)
  • Have moderate to severe depression or active suicidal ideation/behavior
  • Have active malignancy
  • Consume substances that could confound opioid toxicology results (e.g., poppy-seed products)

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active (tDCS) + Active TUS
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS)
Device: Active Comparator: Active tDCS + Active TUS

Device: Active comparator device: Active transcranial Direct Current Stimulation (tDCS). Subjects will receive 20 minutes of active tDCS. During each Active stimulation session, stimulation will be applied for the full 20 minutes.

Device: Active comparator device: Active Transcranial Ultrasound (TUS). Subjects will receive 20 minutes of active Transcranial Ultrasound (TUS). During active stimulation the (TUS) will be active for the full 20 minutes.
Sham Comparator: Sham (tDCS) + Sham TUS
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
Device: Sham Comparator: Sham tDCS + Sham TUS

Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of sham tDCS. In the sham group, the tDCS device will not be active for the full 20 minutes.

Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of sham TUS. During sham stimulation the ultrasound will not be active for the full 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in drug use from baseline.
Time Frame: Measured for approximately 6 weeks
American Pain Foundation Pain/Medication Diary is used to monitor Drug Use overtime after stimulation for approximately 6 weeks.
Measured for approximately 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Verbal Rating Scale (VRS) for Pain
Time Frame: Measured for approximately 6 weeks
Changes in VRS for Pain will be measured in order to determine if tDCS + ESSTIM is effective in reducing the pain of subjects with Chronic Pain (CP) and Opioid Use Disorder(OUD) when compared to the SHAM group.Verbal Rating Scale (VRS) for Pain is a categorical scale of pain with categories: none, mild, moderate, severe pain intensity.
Measured for approximately 6 weeks
Changes in pain as measured by the Visual Analog Scale (VAS)
Time Frame: Measured for approximately 6 weeks
Changes in VAS for Pain will be measured in order to determine if tDCS + ESSTIM is effective in reducing the pain of subjects with Chronic Pain (CP) and Opioid Use Disorder(OUD) when compared to the SHAM group.Visual Analog Scale (VAS) for Pain will assess a patient's pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable).
Measured for approximately 6 weeks
Safety measures
Time Frame: Measured for approximately 6 weeks
The investigators will measure safety through a standardized neurological exam, which will include the assessment of cognitive domains including memory, attention, mood (scaled as normal or abnormal).
Measured for approximately 6 weeks
Study 36-Item Short Form (SF-36)
Time Frame: Measured for approximately 6 weeks
This is a health survey using a scale from 0 (worst) to 100 (best)
Measured for approximately 6 weeks
Patient Health Questionnaire (PHQ-9)
Time Frame: Measured for approximately 6 weeks
This questionnaire screens for depression with a score of 0 (best) to 27 (worst)
Measured for approximately 6 weeks
Electroencephalography (EEG) recording:
Time Frame: Measured for approximately 6 weeks
previous: EEG recording: On the first baseline visit, on the first day of Week 1, at the end of each stimulation week, and at the follow up visits. EEG recordings will be taken to monitor changes in power in different frequency bands including (theta, alpha, beta and gamma) for 20 min.
Measured for approximately 6 weeks
Ultimatum Game:
Time Frame: Measured for approximately 6 weeks
This task evaluates reward, salience and executive network behavioral correlates
Measured for approximately 6 weeks
Risk Task:
Time Frame: Measured for approximately 6 weeks
The task is designed to analyze the relationship between prediction and reward (and penalty) is associated with the choice of the least likely outcome, and the smallest reward (and penalty).
Measured for approximately 6 weeks
Inhibitory Control Task:
Time Frame: Measured for approximately 6 weeks
We will assess the interaction between reward processing (via the presence or absence of reward) and mechanisms of inhibitory control.
Measured for approximately 6 weeks
Opioid Cue-Exposure Task for Craving Assessment:
Time Frame: Measured for approximately 6 weeks
A set of randomized videos showing scenes of people using opioids will aid assessment of craving.
Measured for approximately 6 weeks
Hair follicle drug test
Time Frame: Measured for approximately 6 weeks
A hair follicle drug test screens for illicit drug use and the misuse of prescription medication. The sample is then analyzed for signs of drug use over 90 days. The results will be measured as positive or negative.
Measured for approximately 6 weeks
National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST)
Time Frame: Measured for approximately 6 weeks
Clinician's Screening Tool for Drug Use in General Medical Settings which implements a scale from 0-3 "Low Risk", 3-26 " Moderate Risk", and 27+ "High Risk"
Measured for approximately 6 weeks
Obsessive-Compulsive Drinking/Drug Use Scale (OCDS)
Time Frame: Measured for approximately 6 weeks
This measure reflects obsessionality and compulsivity related to craving and drinking behavior with a total score ranging from 0 to 64 (with 64 being the worst).
Measured for approximately 6 weeks
15-item Barrett Impulsivity scale
Time Frame: Measured for approximately 6 weeks
15-item Barrett Impulsivity scale is used to measure impulsivity with a total score ranging from 15 to 60 (with 15 lower level of impulsivity and 60 higher levels of impulsivity.
Measured for approximately 6 weeks
National Institute on Drug Abuse (NIDA) Quick Screen
Time Frame: Measured for approximately 6 weeks
The NIDA Quick Screen is a validated instrument designed to assist providers in screening adults for substance use which has a yes/no scale (with "no" being best and "yes" being worse)
Measured for approximately 6 weeks
Urine drug test
Time Frame: Measured for approximately 6 weeks
A Urine drug test screens for illicit drug use and the misuse of prescription medication. The sample is then analyzed for signs of drug use during the past few days. The results will be measured as positive or negative.
Measured for approximately 6 weeks

Collaborators and Investigators

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

Sponsor

Case Western Reserve University

Collaborators

Highland Instruments, Inc.

Investigators

  • Principal Investigator: Ciro R Estebanez, MD PhD, University Hospitals Cleveland Medical Center/ Case Western Reserve 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)

April 4, 2021

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20190760

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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