Optimization of NIBS for Treatment of Addiction

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Opioid-use Disorder, Chronic Pain

In brief

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.

Key facts

Study ID

NCT04379115

Run by

Case Western Reserve University

People needed

126

Starts

2021-04-04

Expected to finish

2027-10-31

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

Where it is running

• University of Illinois Health/ University of Illinois at Chicago — Hinsdale, Illinois, United States (enrolling)
• Spaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center — Cambridge, Massachusetts, United States (enrolling)
• University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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