Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 3
- 主要终点
- Change in drug use from baseline.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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)
干预措施: 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).
干预措施: Sham Comparator: Sham tDCS + Sham TUS (Device)
结局指标
主要结局
Change in drug use from baseline.
时间窗: Measured for approximately 6 weeks
American Pain Foundation Pain/Medication Diary is used to monitor Drug Use overtime after stimulation for approximately 6 weeks.
次要结局
- 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)
研究者
Ciro Ramos Estebanez, MD., Ph.D.
Director Of Research Neurosciences Institute UHCMC
Case Western Reserve University