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Recruiting NCT04379115

Optimization of NIBS for Treatment of Addiction

No phase Interventional Opioid-use Disorder Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active Comparator: Active tDCS + Active TUS, Sham Comparator: Sham tDCS + Sham TUS.
Who it may be relevant to
Registry conditions: Opioid-use Disorder, Chronic Pain. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction

Overview

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.

Interventions

  • Device 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.
  • Device 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 measures

  • Change in drug use from baseline. [Time frame: Measured for approximately 6 weeks]
Secondary outcome measures (12)
  • Changes in the Verbal Rating Scale (VRS) for Pain [Time frame: Measured for approximately 6 weeks]
  • Changes in pain as measured by the Visual Analog Scale (VAS) [Time frame: Measured for approximately 6 weeks]
  • Safety measures [Time frame: Measured for approximately 6 weeks]
  • Study 36-Item Short Form (SF-36) [Time frame: Measured for approximately 6 weeks]
  • Patient Health Questionnaire (PHQ-9) [Time frame: Measured for approximately 6 weeks]
  • Electroencephalography (EEG) recording: [Time frame: Measured for approximately 6 weeks]
  • Ultimatum Game: [Time frame: Measured for approximately 6 weeks]
  • Risk Task: [Time frame: Measured for approximately 6 weeks]
  • Inhibitory Control Task: [Time frame: Measured for approximately 6 weeks]
  • Opioid Cue-Exposure Task for Craving Assessment: [Time frame: Measured for approximately 6 weeks]
  • Hair follicle drug test [Time frame: Measured for approximately 6 weeks]
  • National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST) [Time frame: Measured for approximately 6 weeks]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 3 centers
  • University of Illinois Health/ University of Illinois at Chicago — Hinsdale
  • Spaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center — Cambridge
  • University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit — Cleveland

Identifiers

NCT: NCT04379115 · STUDY20190760

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗