Optimization of NIBS for Treatment of Addiction
RecruitingNot applicableNCT04379115
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction
- Conditions
- Interventions
- Device: Active Comparator: Active tDCS + Active TUS
- Device: Sham Comparator: Sham tDCS + Sham TUS
- Sponsor
- Case Western Reserve University
- Collaborators
- Highland Instruments, Inc.
- Start date
- 2021-04-04
- Primary completion
- 2027-10-31
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04379115