Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 126
- Locations
- 3
- Primary Endpoint
- Change in drug use from baseline.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Triple
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
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)
Intervention: Active Comparator: Active tDCS + Active TUS (Device)
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).
Intervention: Sham Comparator: Sham tDCS + Sham TUS (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Opioid Cue-Exposure Task for Craving Assessment:(Measured for approximately 6 weeks)
- Obsessive-Compulsive Drinking/Drug Use Scale (OCDS)(Measured for approximately 6 weeks)
- 15-item Barrett Impulsivity scale(Measured for approximately 6 weeks)
- Changes in pain as measured by the Visual Analog Scale (VAS)(Measured for approximately 6 weeks)
- Safety measures(Measured for approximately 6 weeks)
- Study 36-Item Short Form (SF-36)(Measured for approximately 6 weeks)
- Ultimatum Game:(Measured for approximately 6 weeks)
- National Institute on Drug Abuse (NIDA) Quick Screen(Measured for approximately 6 weeks)
- Patient Health Questionnaire (PHQ-9)(Measured for approximately 6 weeks)
- Inhibitory Control Task:(Measured for approximately 6 weeks)
- National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST)(Measured for approximately 6 weeks)
- Urine drug test(Measured for approximately 6 weeks)
- Electroencephalography (EEG) recording:(Measured for approximately 6 weeks)
- Hair follicle drug test(Measured for approximately 6 weeks)
- Changes in the Verbal Rating Scale (VRS) for Pain(Measured for approximately 6 weeks)
- Risk Task:(Measured for approximately 6 weeks)
Investigators
Ciro Ramos Estebanez, MD., Ph.D.
Director Of Research Neurosciences Institute UHCMC
Case Western Reserve University