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NCT04379115NARecruiting

Optimization of NIBS for Treatment of Addiction

Case Western Reserve University

Start Date

4/4/2021

Completion Date

10/31/2027

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 Criteria

Age Range: 18 years to 85 years

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)

Interventions

DEVICE

Active Comparator: Active tDCS + Active TUS

DEVICE

Sham Comparator: Sham tDCS + Sham TUS

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Conditions

Opioid-use DisorderChronic Pain

Locations

University of Illinois Health/ University of Illinois at Chicago

Hinsdale, Illinois 60612

United States

Spaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center

Cambridge, Massachusetts 02138

United States

University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit

Cleveland, Ohio 44106-1716

United States