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Transcranial Stimulation for Opioid Use Disorder and Chronic Pain

This study is looking at how two types of non-invasive brain stimulation, transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS), might help people with opioid use disorder and chronic pain. Researchers want to see if these active stimulations can reduce drug use and improve well-being compared to sham (inactive) stimulation. You might be able to join if you are 18-85 years old, have an opioid use disorder, experience opioid cravings, and are currently receiving methadone maintenance treatment. The main goal is to see if drug use decreases over about six weeks.

Study design
This interventional study plans to enroll 126 participants. It compares active tDCS and TUS to sham (inactive) tDCS and TUS.
What's involved
You would receive 20 minutes of either active or sham tDCS and TUS during each session. The primary endpoint, change in drug use, is measured for approximately 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
The main outcome of the study, change in drug use, is measured for approximately 6 weeks.

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NCT04379115

Optimization of NIBS for Treatment of Addiction

Recruiting
NAAges 18–85InterventionalTreatment
Case Western Reserve University
~126 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:Active Comparator: Active tDCS + Active TUSSham Comparator: Sham tDCS + Sham TUS

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in drug use from baseline.
Measured over Measured for approximately 6 weeks

Conditions

Opioid-use Disorder
Chronic Pain

Explore related trials

Chronic PainOpioid Use Disorder

Where it's being run

3 sites across 3 states
Illinois1
Massachusetts1
Ohio1

Study leadership

  • Ciro R Estebanez, MD PhD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center/ Case Western Reserve University

Who to contact

Kimberly Bass, RN
[email protected]
216-286-7250
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Change in drug use from baseline.Measured for approximately 6 weeks

    American Pain Foundation Pain/Medication Diary is used to monitor Drug Use overtime after stimulation for approximately 6 weeks.