Using brain stimulation to treat opioid addiction and chronic pain
Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction
This study is testing if a new brain stimulation treatment can help people with opioid addiction and chronic pain feel better compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Case Western Reserve University Academic / other |
| Locations | 3 sites (Hinsdale, Illinois and 2 other locations) |
| Trial ID | NCT04379115 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with a diagnosis of opioid-use disorder and chronic pain lasting more than six months.
Not a fit: Patients who are pregnant, have a history of neurological disorders, or are currently using certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a novel non-pharmacological treatment for individuals struggling with opioid addiction and chronic pain.
How similar studies have performed: While the combination of tDCS and TUS is a novel approach, previous studies have shown promise in using brain stimulation techniques for addiction treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hinsdale, Illinois and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.