Deep Brain Stimulation (DBS) for the Treatment of Refractory Alcohol Use Disorder (AUD): Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events (safety and tolerability)
研究概览
简要总结
This is a phase I, non-blinded, non-randomized, pilot trial for safety and efficacy of DBS for AUD. Patients who meet inclusion and exclusion criteria will be identified and recruited from the practices of Sunnybrook psychiatrists. Five (5) to ten (10) subjects will be enrolled and study duration for each patient will be of one (1) year. Our primary objective is to establish the safety of DBS in a patient population with treatment refractory AUD. In addition to demonstrating safety, our second primary objective will be to evaluate if DBS-targeted nucleus accumbens in alcoholism is efficacious in the treatment-refractory patients with AUD. This will be measured by various outcome measures that will include validated scales to assess addiction and craving behaviours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or Male patients between age 18-70
- •Diagnosis of alcohol use disorder (AUD) as defined by the Diagnostic and Statistical Manual fifth edition (DSM-5).
- •History of AUD for at least 2 years, with evidence of repeated failure to respond to evidence-based AUD treatments (psychosocial treatments plus pharmacotherapies such as disulfiram, naltrexone and acamprosate).
- •Alcohol Use Disorders Identification Test (AUDIT) Scale Score >8
- •Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols
排除标准
- •Any past or current evidence of psychosis or mania
- •Current suicidal or homicidal ideation
- •Active neurologic disease, such as epilepsy
- •Visible brain damage or atrophy in CT or MRI scan
- •Any contraindication to MRI or positron emission tomography (PET) scanning
- •Likely to relocate or move during the study's one year duration
- •Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure.
- •Patients with renal dysfunction (GFR<60)
- •Pregnant or lactating
研究组 & 干预措施
Deep Brain Stimulation Treatment
干预措施: Deep Brain Stimulation (Device)
结局指标
主要结局
Incidence of treatment-emergent adverse events (safety and tolerability)
时间窗: 6 months
Our primary objective is to establish the safety of deep brain stimulation in a patient population with treatment refractory alcohol use disorder. This is an exploratory pilot study. safety will be reported in the form of adverse event collection, and reported for each patient recruited into the study. Infection, hemorrhage, seizure, sensorymotor disturbance, oculomotor disturbance, or worsening on any adjunctive measure scales used will be reported. These will all be reported on a case-by-case basis, and presented descriptively in the publication. (no specific scale will be used).
Change in Alcohol consumption measured with the alcohol timeline followback
时间窗: 6 months
The amount of alcohol consumption preoperatively will be compared with the amount of alcohol consumption postoperatively using the alcohol timeline followback method at 6 months (compared to the preoperative baseline). This will be administered by a psychometrist, and reported as average number of standard drinks consumed daily and weekly during the 6 month postoperative period. An increase from preoperative values is considered a worse outcome, and a decrease in number is an improvement.
次要结局
- Alcohol Dependency Scale(6 months. This scale is scored out of 47, and will be administered by a psychometrist preoperatively and at 6 months postoperatively. Higher scores are considered worse, so a decrease from baseline is an improvement.)
- Hamilton Depression Scale (HAMD)(6 months)
- Beck Depression and Anxiety Inventory (BDI and BAI)(6 months. Both the BDI and BAI are scored out of 63, with higher scores indicating a worse outcome. They will be administered by a psychometrist.)
- Alcohol Urge Questionnaire (AUQ)(6 months)
- Alcohol Use Disorder Identification Test (AUDIT)(6 months)
研究者
Dr. Nir Lipsman
Principal Investigator
Sunnybrook Health Sciences Centre