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Optimization of NIBS for Treatment of Addiction | Clinical Trials | Clareo Health

RECRUITINGNA

Optimization of NIBS for Treatment of Addiction

Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction

NCT04379115•Case Western Reserve University

Summary

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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

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)

Locations (3)

University of Illinois Health/ University of Illinois at Chicago

Hinsdale, Illinois, United States

Spaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center

Cambridge, Massachusetts, United States

University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit

Cleveland, Ohio, United States

Key Dates

Start Date

April 4, 2021

Primary Completion Date

October 31, 2027

Completion Date

October 31, 2027

Last Updated

March 4, 2026

Enrollment

126

ESTIMATED participants

Conditions

Opioid-use DisorderChronic Pain

Interventions

Active Comparator: Active tDCS + Active TUS

DEVICE

Sham Comparator: Sham tDCS + Sham TUS

DEVICE

Contacts

Kimberly Bass, RN

CONTACT

216-286-7250 kimberly.bass@uhhospitals.org

Mario Becerra, RN

CONTACT

216-844-1734 Mario.Becerra@UHHospitals.org

Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Optimization of NIBS for Treatment of Addiction

Inclusion Criteria

Exclusion Criteria

Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)

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