Optimization of NIBS for Treatment of Addiction

NCT ID
NCT04379115
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Case Western Reserve University
Conditions
Chronic Pain, Opioid-use Disorder

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction

Enrollment: 126 participants (Estimated).

What is being studied

  • Device: Active Comparator: Active tDCS + Active TUS
  • Device: Sham Comparator: Sham tDCS + Sham TUS

Who may be eligible

Ages
18 Years to 85 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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)

Study locations

3 study locations are listed.

Recruiting site status is explicitly provided for 3 locations; 3 are listed as Recruiting.

Countries: United States

  • Illinois, United States: 1
  • Massachusetts, United States: 1
  • Ohio, United States: 1

Sample of listed locations

  • University of Illinois Health/ University of Illinois at Chicago — Hinsdale, Illinois, 60612, United States — Recruiting
  • Spaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center — Cambridge, Massachusetts, 02138, United States — Recruiting
  • University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit — Cleveland, Ohio, 44106-1716, United States — Recruiting

Study details

Start date
April 4, 2021
Primary completion date
October 31, 2027
Completion date
October 31, 2027
First posted
May 7, 2020
Collaborators
Highland Instruments, Inc.

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT04379115
Registry last updated
March 4, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT04379115 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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