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Trial record 1 of 1 for:    Optimization of Noninvasive Brain Stimulation for treatment of Addiction
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Optimization of NIBS for Treatment of Addiction

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ClinicalTrials.gov Identifier: NCT04379115
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
Highland Instruments, Inc.
Information provided by (Responsible Party):
Ciro Ramos Estebanez, Case Western Reserve University

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Chronic Pain Device: Active Comparator: Active tDCS + Active TUS Device: Sham Comparator: Sham tDCS + Sham TUS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single-center, double-blinded, placebo controlled, randomized study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Triple
Primary Purpose: Treatment
Official Title: Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction
Actual Study Start Date : February 18, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
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)
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.


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).
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 :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Providing informed consent to participate in the study.
  2. 18 to 85 years old.
  3. Having a diagnosis of OUD, in the setting of CP:

    • OUD of more than 6 months duration as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5) [64] and with a positive hair follicle test (i.e., opioid use in the last ~90 days), OR a positive urine toxicology screen.
    • and CP per the American Society of Interventional Pain Physicians (ASIPP) International Association for the Study of Pain (IASPP) [65], having pain for at least 6 months, and not responding to first line therapies.
  4. Lives in the immediate area with no plans to relocate

Exclusion Criteria:

  1. The subject is pregnant.
  2. Recently started on antiepileptic drug therapy.
  3. History of illegal drug abuse (except for opioids) within the past 6 months as self- reported.
  4. . Ingestion of poppy seeds or herbal teas containing Papaveris Fructus (may cause a positive opiate test for morphine, codeine [66, 67]).
  5. History of neurological disorders involving stroke, brain tumors, or epilepsy as self- reported (note patients will also be evaluated via electroencephalography (EEG) at baseline 1 week prior to stimulation and any patient showing abnormal EEG activity will be removed)).
  6. History of unexplained fainting spells as self-reported.
  7. History of head injury resulting in more than a momentary loss of consciousness as self-reported.
  8. History of brain surgery as self-reported.
  9. Contraindications to tDCS applied in conjunction with TUS:

    • Metal in the head, or
    • Implanted brain medical devices.
  10. Suffering from severe depression (with a score of >30 in the Beck Depression Inventory (BDI), PHQ-9≥10).
  11. Active malignancy.
  12. History of suicidal behavior or suicide attempts.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379115


Contacts
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Contact: Megan O'Neill Miller 216-844-4720 megan.miller3@uhhospitals.org
Contact: Kimberly Bright (216) 844-0474 kimberly.Bright@uhhospitals.org

Locations
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United States, Ohio
University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit Recruiting
Cleveland, Ohio, United States, 44106-1716
Contact: Jillian Russell, MSN, RN-BC    216-844-4901    Jillian.Russell@uhhospitals.org   
Contact: Ciro Ramos Estebanez, MD, PhD    216) 844-3194‬    Ciro.RamosEstebanez@UHhospitals.org   
Sponsors and Collaborators
Case Western Reserve University
Highland Instruments, Inc.
Investigators
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Principal Investigator: Ciro Ramos Estebanez, MD PhD University Hospitals Cleveland Medical Center/ Case Western Reserve University
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Responsible Party: Ciro Ramos Estebanez, Director Of Research Neurosciences Institute UHCMC, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT04379115    
Other Study ID Numbers: STUDY20190760
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Opioid-Related Disorders
Pain
Neurologic Manifestations
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders