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RECRUITINGINTERVENTIONAL

Optimization of NIBS for Treatment of Addiction

Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Inclusion Criteria Participants must meet all of the following: - Provide willing to sign a consent form - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

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.

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.

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