NCT04379115NARecruiting
Optimization of NIBS for Treatment of Addiction
Case Western Reserve University
Start Date
4/4/2021
Completion Date
10/31/2027
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
Age Range: 18 years to 85 years
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)
Interventions
DEVICE
Active Comparator: Active tDCS + Active TUS
DEVICE
Sham Comparator: Sham tDCS + Sham TUS
Conditions
Opioid-use DisorderChronic Pain
Locations
University of Illinois Health/ University of Illinois at Chicago
Hinsdale, Illinois 60612
United States
Spaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center
Cambridge, Massachusetts 02138
United States
University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit
Cleveland, Ohio 44106-1716
United States