Who is sponsoring NCT04379115?

NCT04379115 is sponsored by Case Western Reserve University.

What drugs are being tested in NCT04379115?

Interventions in NCT04379115: Active Comparator: Active tDCS + Active TUS, Sham Comparator: Sham tDCS + Sham TUS.

What condition does NCT04379115 study?

NCT04379115 studies Opioid-use Disorder, Chronic Pain.

Is NCT04379115 still recruiting?

NCT04379115 is currently recruiting now. Last updated 4 March 2026.

Last reviewed 2026-03-04 · How we verify

NCT04379115

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Optimization of NIBS for Treatment of Addiction

Recruiting now NA Last updated 4 March 2026

What this trial tests

NA trial testing Active Comparator: Active tDCS + Active TUS in Opioid-use Disorder in 126 participants. Currently enrolling.

Timeline

4 April 2021

Primary endpoint
31 October 2027

31 October 2027

Quick facts

Lead sponsor	Case Western Reserve University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	126
Start date	4 April 2021
Primary completion	31 October 2027
Estimated completion	31 October 2027
Sites	3 locations across United States

Drugs / interventions tested

Active Comparator: Active tDCS + Active TUS
Sham Comparator: Sham tDCS + Sham TUS

Conditions studied

Opioid-use Disorder — all drugs for Opioid-use Disorder →
Chronic Pain — all drugs for Chronic Pain →

Sponsor

Case Western Reserve University

Who can join

Adults 18 to 85, any sex, with Opioid-use Disorder or Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Current state of clinical ultrasound neuromodulation.
Matt E, Radjenovic S, Mitterwallner M, Beisteiner R. · · 2024 · cited 27× · PMID 38962179 · DOI 10.3389/fnins.2024.1420255
Cost-Effectiveness Analysis to Inform Randomized Controlled Trial Design in Chronic Pain Research: Methods for Guiding Decisions on the Addition of a Run-In Period.
Rafferty H, Rocha E, Gonzalez-Mego P, Ramos CL, et al · · 2022 · cited 1× · PMID 36561218 · DOI 10.21801/ppcrj.2022.82.5
Transcranial Ultrasound Stimulation as an Emerging Treatment for Substance use Disorder: Promise and Precaution.
Komarnyckyj M, Sherpa NN, Lawn W, Fouragnan E. · · 2026 · PMID 42079841 · DOI 10.1007/s40429-026-00734-2

Verify or expand the search:

Other trials of Active Comparator: Active tDCS + Active TUS

Trials testing the same drug.

NCT03625752 — Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain · NA · active not recruiting

Other recruiting trials for Opioid-use Disorder

Currently open trials in the same condition.

NCT04783558 — Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk · NA · active not recruiting
NCT05011266 — Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder · Phase 2, PHASE3 · recruiting
NCT05039554 — Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment · NA · recruiting
NCT05033028 — Smartphones for Opiate Addiction Recovery · Phase 3 · recruiting
NCT04738825 — Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With Pr · NA · recruiting

Other Case Western Reserve University trials

Trials by the same sponsor.

NCT07216950 — Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER) · Phase 2 · not yet recruiting
NCT07006935 — REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health) · NA · not yet recruiting
NCT07214233 — Youth Empowerment and Safety Intervention · NA · recruiting
NCT07225582 — Development of Optimal Sensory Feedback Strategies to Maximize Function After Tetraplegia · NA · recruiting
NCT07217249 — Effect of Donor Diabetes and Other Factors on Corneal Transplant Endothelial Cell Loss and Success at 5 Years · NA · enrolling by invitation

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04379115 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Case Western Reserve University
Last refreshed: 4 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04379115.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing