Recruiting

NIBS

Sponsor:

Case Western Reserve University

Code:

NCT04379115

Conditions

Opioid-use Disorder

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Active Comparator: Active tDCS + Active TUS

Sham Comparator: Sham tDCS + Sham TUS

Study Details

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.

Conditions

Opioid-use Disorder

Chronic Pain

Study ID

NCT04379115

Start date

Apr 4, 2021

Status verified date

Mar, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active (tDCS) + Active TUS

Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS)

sham comparator: Sham (tDCS) + Sham TUS

Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Interventions

Active Comparator: Active tDCS + Active TUS

Device: Active comparator device: Active transcranial Direct Current Stimulation (tDCS). Subjects will receive 20 minutes of active tDCS. During each Active stimulation session, stimulation will be applied for the full 20 minutes.

Device: Active comparator device: Active Transcranial Ultrasound (TUS). Subjects will receive 20 minutes of active Transcranial Ultrasound (TUS). During active stimulation the (TUS) will be active for the full 20 minutes.

Sham Comparator: Sham tDCS + Sham TUS

Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of sham tDCS. In the sham group, the tDCS device will not be active for the full 20 minutes.

Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of sham TUS. During sham stimulation the ultrasound will not be active for the full 20 minutes.

Primary outcome measure

  • Change in drug use from baseline. [ Time Frame: Measured for approximately 6 weeks ]

Central Contacts and Locations

Central contacts

Kimberly Bass, RN

216-286-7250kimberly.bass@uhhospitals.org

Mario Becerra, RN

216-844-1734Mario.Becerra@UHHospitals.org

Locations

University of Illinois Health/ University of Illinois at Chicago

Recruiting

Hinsdale, Illinois, United States, 60612

Contacts

Ming-Chieh Shun, PhD

mshun@uic.edu

Ciro Ramos Estebanez, MD, PhD

cramoses@icloud.com

Principal Investigator:

Ciro Ramos Estebanez, MD, PhD

Spaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center

Recruiting

Cambridge, Massachusetts, United States, 02138

Contacts

Elly Pichardo, MD

617-952-6158epichardo@mgb.org

Felipe Fregni, MD, PhD

Fregni.Felipe@mgh.harvard.edu

University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit

Recruiting

Cleveland, Ohio, United States, 44106-1716

Contacts

Salim Hayek, MD

216-983-2085salim.hayek@uhhospitals.org

Ciro R Estebanez, MD, PhD

cramoses@icloud.com

More Information

Sponsor

Case Western Reserve University

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2026-03-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.