Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT04379115

Optimization of NIBS for Treatment of Addiction

Led by Case Western Reserve University · Updated on 2026-03-04

126

Participants Needed

3

Research Sites

343 weeks

Total Duration

On this page

Sponsors

C

Case Western Reserve University

Lead Sponsor

H

Highland Instruments, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Optimization of NIBS for Treatment of Addiction

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University of Illinois Health/ University of Illinois at Chicago

Hinsdale, Illinois, United States, 60612

Actively Recruiting

2

Spaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center

Cambridge, Massachusetts, United States, 02138

Actively Recruiting

3

University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit

Cleveland, Ohio, United States, 44106-1716

Actively Recruiting

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Research Team

K

Kimberly Bass, RN

CONTACT

M

Mario Becerra, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Optimization of NIBS for Treatment of Addiction | DecenTrialz