Chronic Pain, Opioid-use Disorder
Conditions
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.
Interventions
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.
DEVICESham 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.
Sponsors
Case Western Reserve University
Highland Instruments, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Triple
Intervention model description
single-center, double-blinded, placebo controlled, randomized study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in drug use from baseline. | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Verbal Rating Scale (VRS) for Pain | 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. |
| Changes in pain as measured by the Visual Analog Scale (VAS) | 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). |
| Safety measures | 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). |
| Study 36-Item Short Form (SF-36) | Measured for approximately 6 weeks | This is a health survey using a scale from 0 (worst) to 100 (best) |
| Patient Health Questionnaire (PHQ-9) | Measured for approximately 6 weeks | This questionnaire screens for depression with a score of 0 (best) to 27 (worst) |
| Electroencephalography (EEG) recording: | 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. |
| Ultimatum Game: | Measured for approximately 6 weeks | This task evaluates reward, salience and executive network behavioral correlates |
| Risk Task: | 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). |
| Inhibitory Control Task: | 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. |
| Opioid Cue-Exposure Task for Craving Assessment: | Measured for approximately 6 weeks | A set of randomized videos showing scenes of people using opioids will aid assessment of craving. |
| Hair follicle drug test | 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. |
| National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST) | 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" |
| Obsessive-Compulsive Drinking/Drug Use Scale (OCDS) | 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). |
| 15-item Barrett Impulsivity scale | 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. |
| National Institute on Drug Abuse (NIDA) Quick Screen | 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) |
| Urine drug test | 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. |
Countries
United States
Contacts
CONTACTKimberly Bass, RN
CONTACTMario Becerra, RN
PRINCIPAL_INVESTIGATORCiro R Estebanez, MD PhD
University Hospitals Cleveland Medical Center/ Case Western Reserve University
Outcome results
None listed