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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
126
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 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.
University of Illinois Health/ University of Illinois at Chicago
Hinsdale, Illinois, United States
RECRUITINGSpaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center
Cambridge, Massachusetts, United States
RECRUITINGUniversity Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit
Cleveland, Ohio, United States
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.
Time frame: Measured for approximately 6 weeks
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.
Time frame: Measured for approximately 6 weeks
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).
Time frame: Measured for approximately 6 weeks
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).
Time frame: Measured for approximately 6 weeks
Study 36-Item Short Form (SF-36)
This is a health survey using a scale from 0 (worst) to 100 (best)
Time frame: Measured for approximately 6 weeks
Patient Health Questionnaire (PHQ-9)
This questionnaire screens for depression with a score of 0 (best) to 27 (worst)
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Time frame: Measured for approximately 6 weeks
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.
Time frame: Measured for approximately 6 weeks
Ultimatum Game:
This task evaluates reward, salience and executive network behavioral correlates
Time frame: Measured for approximately 6 weeks
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).
Time frame: Measured for approximately 6 weeks
Inhibitory Control Task:
We will assess the interaction between reward processing (via the presence or absence of reward) and mechanisms of inhibitory control.
Time frame: Measured for approximately 6 weeks
Opioid Cue-Exposure Task for Craving Assessment:
A set of randomized videos showing scenes of people using opioids will aid assessment of craving.
Time frame: Measured for approximately 6 weeks
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.
Time frame: Measured for approximately 6 weeks
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"
Time frame: Measured for approximately 6 weeks
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).
Time frame: Measured for approximately 6 weeks
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.
Time frame: Measured for approximately 6 weeks
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)
Time frame: Measured for approximately 6 weeks
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.
Time frame: Measured for approximately 6 weeks