NCT04379115 Optimization of NIBS for Treatment of Addiction
| NCT ID | NCT04379115 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Case Western Reserve University |
| Condition | Opioid-use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2021-04-04 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 126 participants in total. It began in 2021-04-04 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Ciro R Estebanez, MD PhD
PRINCIPAL INVESTIGATOR
University Hospitals Cleveland Medical Center/ Case Western Reserve University
Frequently Asked Questions
Who can join the NCT04379115 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Opioid-use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04379115 currently recruiting?
Yes, NCT04379115 is actively recruiting participants. Contact the research team at kimberly.bass@uhhospitals.org for enrollment information.
Where is the NCT04379115 trial being conducted?
This trial is being conducted at Hinsdale, United States, Cambridge, United States, Cleveland, United States.
Who is sponsoring the NCT04379115 clinical trial?
NCT04379115 is sponsored by Case Western Reserve University. The principal investigator is Ciro R Estebanez, MD PhD at University Hospitals Cleveland Medical Center/ Case Western Reserve University. The trial plans to enroll 126 participants.