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NCT Number: NCT04379115

Optimization of NIBS for Treatment of Addiction

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Chronic Pain Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Health/ University of Illinois at Chicago, Hinsdale, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in drug use from baseline.

    Time frame: Measured for approximately 6 weeks

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

Secondary outcomes

  1. Changes in the Verbal Rating Scale (VRS) for Pain

    Time frame: Measured for approximately 6 weeks

    Changes in VRS for Pain will be measured in order to determine if tDCS + ESSTIM is effective in reducing the pain of subjects with Chronic Pain (CP) and Opioid Use Disorder(OUD) when compared to the SHAM group.Verbal Rating Scale (VRS) for Pain is a categorical scale of pain with categories: none, mild, moderate, severe pain intensity.

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

    Time frame: Measured for approximately 6 weeks

    Changes in VAS for Pain will be measured in order to determine if tDCS + ESSTIM is effective in reducing the pain of subjects with Chronic Pain (CP) and Opioid Use Disorder(OUD) when compared to the SHAM group.Visual Analog Scale (VAS) for Pain will assess a patient's pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable).

  3. Safety measures

    Time frame: Measured for approximately 6 weeks

    The investigators will measure safety through a standardized neurological exam, which will include the assessment of cognitive domains including memory, attention, mood (scaled as normal or abnormal).

  4. Study 36-Item Short Form (SF-36)

    Time frame: Measured for approximately 6 weeks

    This is a health survey using a scale from 0 (worst) to 100 (best)

  5. Patient Health Questionnaire (PHQ-9)

    Time frame: Measured for approximately 6 weeks

    This questionnaire screens for depression with a score of 0 (best) to 27 (worst)

  6. Electroencephalography (EEG) recording:

    Time frame: Measured for approximately 6 weeks

    previous: EEG recording: On the first baseline visit, on the first day of Week 1, at the end of each stimulation week, and at the follow up visits. EEG recordings will be taken to monitor changes in power in different frequency bands including (theta, alpha, beta and gamma) for 20 min.

  7. Ultimatum Game:

    Time frame: Measured for approximately 6 weeks

    This task evaluates reward, salience and executive network behavioral correlates

  8. Risk Task:

    Time frame: Measured for approximately 6 weeks

    The task is designed to analyze the relationship between prediction and reward (and penalty) is associated with the choice of the least likely outcome, and the smallest reward (and penalty).

  9. Inhibitory Control Task:

    Time frame: Measured for approximately 6 weeks

    We will assess the interaction between reward processing (via the presence or absence of reward) and mechanisms of inhibitory control.

  10. Opioid Cue-Exposure Task for Craving Assessment:

    Time frame: Measured for approximately 6 weeks

    A set of randomized videos showing scenes of people using opioids will aid assessment of craving.

  11. Hair follicle drug test

    Time frame: Measured for approximately 6 weeks

    A hair follicle drug test screens for illicit drug use and the misuse of prescription medication. The sample is then analyzed for signs of drug use over 90 days. The results will be measured as positive or negative.

  12. National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST)

    Time frame: Measured for approximately 6 weeks

    Clinician's Screening Tool for Drug Use in General Medical Settings which implements a scale from 0-3 "Low Risk", 3-26 " Moderate Risk", and 27+ "High Risk"

  13. Obsessive-Compulsive Drinking/Drug Use Scale (OCDS)

    Time frame: Measured for approximately 6 weeks

    This measure reflects obsessionality and compulsivity related to craving and drinking behavior with a total score ranging from 0 to 64 (with 64 being the worst).

  14. 15-item Barrett Impulsivity scale

    Time frame: Measured for approximately 6 weeks

    15-item Barrett Impulsivity scale is used to measure impulsivity with a total score ranging from 15 to 60 (with 15 lower level of impulsivity and 60 higher levels of impulsivity.

  15. National Institute on Drug Abuse (NIDA) Quick Screen

    Time frame: Measured for approximately 6 weeks

    The NIDA Quick Screen is a validated instrument designed to assist providers in screening adults for substance use which has a yes/no scale (with "no" being best and "yes" being worse)

  16. Urine drug test

    Time frame: Measured for approximately 6 weeks

    A Urine drug test screens for illicit drug use and the misuse of prescription medication. The sample is then analyzed for signs of drug use during the past few days. The results will be measured as positive or negative.

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly Bass, RN

CONTACT

[email protected]

216-286-7250

Mario Becerra, RN

CONTACT

[email protected]

216-844-1734

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • Highland Instruments, Inc.

Registry information

Official study title

Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
May 7, 2020
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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