Optimization of NIBS for Treatment of Addiction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCase Western Reserve University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Active Comparator: Active tDCS + Active TUS
DeviceDevice: 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
DeviceDevice: 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.
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: Active (tDCS) + Active TUSActive comparator 1 intervention
Group B: Sham (tDCS) + Sham TUSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Case Western Reserve University
Lead sponsor
Highland Instruments, Inc.
Collaborator
Source ClinicalTrials.gov