Optimization of NIBS for Treatment of Addiction

NCT04379115 | Recruiting DMC

• 1 other identifier: STUDY20190760
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Change in drug use from baseline.

  American Pain Foundation Pain/Medication Diary is used to monitor Drug Use overtime after stimulation for approximately 6 weeks.

  Measured for approximately 6 weeks

Secondary Outcomes (16)

• Changes in the Verbal Rating Scale (VRS) for Pain

  Measured for approximately 6 weeks

• Changes in pain as measured by the Visual Analog Scale (VAS)

  Measured for approximately 6 weeks

• Safety measures

  Measured for approximately 6 weeks

• Study 36-Item Short Form (SF-36)

  Measured for approximately 6 weeks

• Patient Health Questionnaire (PHQ-9)

  Measured for approximately 6 weeks

Study Arms (2)

Active (tDCS) + Active TUS

ACTIVE COMPARATOR

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

Device: Active Comparator: Active tDCS + Active TUS

Sham (tDCS) + Sham TUS

SHAM COMPARATOR

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

Device: Sham Comparator: Sham tDCS + Sham TUS

Interventions

Active Comparator: Active tDCS + Active TUS DEVICE

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.

Active (tDCS) + Active TUS

Sham Comparator: Sham tDCS + Sham TUS DEVICE

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.

Sham (tDCS) + Sham TUS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Case Western Reserve University: lead
• Highland Instruments, Inc.: collaborator

Study Sites (3)

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

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ciro R Estebanez, MD PhD

  University Hospitals Cleveland Medical Center/ Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Bass, RN

CONTACT

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

Mario Becerra, RN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-center, double-blinded, placebo controlled, randomized study.

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 7, 2020
• Study Start: April 4, 2021
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)