Using brain stimulation to treat opioid addiction and chronic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effects of transcranial Direct Current Stimulation (tDCS) combined with Transcranial Ultrasound (TUS) on individuals with opioid-use disorder and chronic pain. Participants will receive either active stimulation or sham stimulation to determine the impact on drug use and psychosocial assessments. The study aims to establish whether active stimulation leads to better outcomes compared to a placebo effect. The research is designed to provide insights into innovative treatment options for addiction in the context of chronic pain.

Why it matters

Who can join: the full rules

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)

Where it's running

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

Study contacts

• Principal investigator: Ciro R Estebanez, MD PhD — University Hospitals Cleveland Medical Center/ Case Western Reserve University
• Study coordinator: Kimberly Bass, RN
• Email: kimberly.bass@uhhospitals.org
• Phone: 216-286-7250

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.