A Randomized, Sham-Controlled Trial Investigating Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Safety and Tolerability as Measured by All Adverse Events Related to DBS
研究概览
简要总结
The purpose of this clinical study is to investigate the safety, tolerability, and feasibility of Deep Brain Stimulation (DBS) of the nucleus accumbens (NAc) and ventral internal capsule (VC) for participants with treatment refractory opioid use disorder (OUD) who have cognitive, behavioral, and functional disability.
详细描述
The overarching goal of this study is to evaluate the safety, tolerability, feasibility and impact on outcomes of NAc/VC DBS for treatment refractory OUD. In treatment refractory OUD, innovative approaches and more invasive interventions including DBS are warranted to improve outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
After completion of surgery, participants will be randomly assigned to one of two groups: Group A or Group B. Group A (DBS-ON only) will have their stimulator turned on after recovering from surgery. Group B (DBS-OFF, then DBS-ON) will receive sham stimulation, meaning the stimulator will remain off until Study Week 12 of the outpatient phase, at which time the stimulator will be turned on and left on for the remainder of the study. Group A will continue to receive stimulation and not have the stimulator turned off. Participant and assessor will not know which group are assigned to until Study Week 12.
入排标准
- 年龄范围
- 22 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22-50 years at time of enrollment.
- •Fulfills current DSM-5 diagnostic criteria for severe OUD with at least a 5-year history.
- •Participants may have comorbid SUD diagnoses at a mild, moderate or severe level, however, OUD must be the primary disorder for which the individual is seeking treatment and the other use disorders must occur in the context of relapse.
- •At least one lifetime overdose survival.
- •Demonstrated greater than five years of refractory symptoms of OUD.
排除标准
- •Diagnosis of acute myocardial infarction or cardiac arrest 1 within the previous 6 months.
- •Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced.
- •Unable to undergo MR-imaging
研究组 & 干预措施
DBS-ON Only
Titration will be based on stimulation parameters used in previous studies examining the role of DBS of the NAc in the treatment of OCD and depression as well as the parameters utilized in the initial pilot study conducted by the team. Participants receive active stimulation after surgery and throughout the remaineder of the study.
干预措施: Deep Brain Stimulation (Device)
DBS-OFF, then DBS-ON
Titration sessions will be conducted identically to the "DBS-ON" arm, the only difference is that no stimulation is delivered for the first 12 weeks and therefore, no actual adjustments made. At Study Week 12, stimulation is turn on and continues for the remainder of the study.
干预措施: Deep Brain Stimulation (Device)
结局指标
主要结局
Safety and Tolerability as Measured by All Adverse Events Related to DBS
时间窗: Outpatient Week 12
Incidence of Study-Emergent Adverse Events. The safety/tolerability primary endpoint will be assessed comparing Grade 3 and 4 adverse events between the Active (DBS-ON) and Sham (DBS-OFF) arms throughout Phase IV (Outpatient Week 12). We will also categorize adverse events by organ system and assess relatedness to any aspect of this proof-of-concept study. Statistical tests will be performed at the request of the Data and Safety Monitoring Board (DSMB).
Opioid Use Assessed Via Quantitative Urine Toxicology
时间窗: Outpatient Week 12
Opioid use will be evaluated through the use of quantitative urine toxicology using gas chromatography/mass spectrometry. The primary outcome comparison between the active and sham arms will be based off participants with undetectable opioid metabolites (assessed via quantitative urine toxicology) throughout the primary Outpatient Week 12 endpoint.
次要结局
- Changes in Cue-Induced Substance Craving (Visual Analog Scale)(Change from Baseline versus Outpatient Week 12)
- Changes in Cognitive Functioning (Standard Neuropsychological Battery)(Change from Baseline versus Outpatient Week 12)
- Changes in Non-Cue Induced Substance Craving (Visual Analog Scale)(Change from Baseline versus Outpatient Week 12)
- Changes in the Brain Reward Circuitry (FDG PET)(Change from Baseline versus Outpatient Week 12)
- Changes in Mood and Emotional Functioning (Comprehensive Psychopathological Rating Scale)(Change from Baseline versus Outpatient Week 12)
- Changes in Cognitive Functioning (Executive Functioning: Flanker, N-Back, Psychomotor Vigilance, Delayed Discounting)(Change from Baseline versus Outpatient Week 12)
- Changes in the Brain Reward Circuitry (Fallypride PET)(Change from Baseline versus Outpatient Week 12)
- Changes in Cognitive Functioning (NIH Toolbox Cognition Battery)(Change from Baseline versus Outpatient Week 12)