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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04379115
Other study ID # STUDY20190760
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 4, 2021
Est. completion date October 31, 2025

Study information

Verified date May 2024
Source Case Western Reserve University
Contact Megan Miller
Phone 216-844-4720
Email megan.miller3@uhhospitals.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 126
Est. completion date October 31, 2025
Est. primary completion date October 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 a positive urine toxicology screen. - or OUD patients who still feel craving or have not received more than 60 mg of methadone/day from the Methadone program. 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 stimulant use as demonstrated by urine toxicology. 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.

Study Design


Intervention

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
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.

Locations

Country Name City State
United States University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit Cleveland Ohio
United States University of Illinois Health/ University of Illinois at Chicago Hinsdale Illinois

Sponsors (2)

Lead Sponsor Collaborator
Case Western Reserve University Highland Instruments, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Changes in the Verbal Rating Scale (VRS) for Pain 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. Measured for approximately 6 weeks
Secondary Changes in pain as measured by the Visual Analog Scale (VAS) 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). Measured for approximately 6 weeks
Secondary Safety measures 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). Measured for approximately 6 weeks
Secondary Study 36-Item Short Form (SF-36) This is a health survey using a scale from 0 (worst) to 100 (best) Measured for approximately 6 weeks
Secondary Patient Health Questionnaire (PHQ-9) This questionnaire screens for depression with a score of 0 (best) to 27 (worst) Measured for approximately 6 weeks
Secondary Electroencephalography (EEG) recording: 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. Measured for approximately 6 weeks
Secondary Ultimatum Game: This task evaluates reward, salience and executive network behavioral correlates Measured for approximately 6 weeks
Secondary Risk Task: 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). Measured for approximately 6 weeks
Secondary Inhibitory Control Task: We will assess the interaction between reward processing (via the presence or absence of reward) and mechanisms of inhibitory control. Measured for approximately 6 weeks
Secondary Opioid Cue-Exposure Task for Craving Assessment: A set of randomized videos showing scenes of people using opioids will aid assessment of craving. Measured for approximately 6 weeks
Secondary Hair follicle drug test 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. Measured for approximately 6 weeks
Secondary National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST) 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" Measured for approximately 6 weeks
Secondary Obsessive-Compulsive Drinking/Drug Use Scale (OCDS) 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). Measured for approximately 6 weeks
Secondary 15-item Barrett Impulsivity scale 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. Measured for approximately 6 weeks
Secondary National Institute on Drug Abuse (NIDA) Quick Screen 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) Measured for approximately 6 weeks
Secondary Urine drug test 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. Measured for approximately 6 weeks
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