Remote Treatment of Alcohol Withdrawal: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Retention in treatment
研究概览
简要总结
This study will evaluate the feasibility of delivering symptom-triggered alcohol withdrawal management by telemedicine and determine whether this intervention is satisfactory to patients.
详细描述
This single-arm pilot feasibility study will recruit actively drinking participants with a history of alcohol withdrawal in order to provide remotely monitored symptom-triggered alcohol withdrawal treatment using telemedicine. Participants will initially complete a screening and eligibility visit. If eligible, participants will then be scheduled for 3-day remote withdrawal management (which can be extended by 1-2 days if medically indicated). During remote withdrawal management, participants will receive symptom-triggered diazepam treatment using a modified version of the Clinical Institute Withdrawal Assessment for Alcohol Scale, revised (CIWA-Ar). Within one week following termination of withdrawal treatment, participants will be scheduled for a remote follow up visit in which they will complete patient satisfaction questionnaires and will be offered weekly counselling sessions and anticraving medication to prevent relapse to alcohol use. Approximately 30 days following treatment initiation, relapse to alcohol use will be assessed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years and older
- •Are actively using alcohol
- •Previously met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) B criteria for alcohol withdrawal
- •Aim to achieve at least 30 days of abstinence as a treatment goal following initiation of remote alcohol withdrawal management
- •Are able to provide informed consent in English.
- •Reside or are able to stay at an address within 2-hours travelling distance from the Centre for Addiction and Mental Health for the entire duration of the remote withdrawal procedure
- •Are enrolled in the Ontario Health Insurance Plan (OHIP)
排除标准
- •History of complicated withdrawal including withdrawal seizures, hallucinosis, or delirium
- •Positive UDS for sedatives or opioids, currently prescribed sedatives or opioids, or diagnosis of sedative-hypnotic or opioid use disorder within the past year (based on assessment). Individuals prescribed low doses of benzodiazepines (e.g. lorazepam 1mg PO daily) or with a positive urine benzodiazepine screen that is not thought to be due to benzodiazepine misuse may be permitted to proceed with the study at the discretion of the study physician.
- •Severe medical or psychiatric comorbidity that would prevent safe participation in the study
- •Contraindications to the safe use of diazepam including: known hypersensitivity to diazepam severe respiratory insufficiency, severe hepatic insufficiency, sleep apnea syndrome, acute narrow-angle glaucoma, and myasthenia gravis. Individuals with sleep apnea may be permitted to proceed with the study at the discretion of the study physician.
- •Active withdrawal symptoms (CIWA-Ar > 12) at the time of the eligibility assessment
- •Active suicidal ideation at the time of eligibility assessment
- •Positive urine pregnancy test, actively breastfeeding, or planning to become pregnant or breastfeed during the study period
- •Lack of stable housing
- •Enrollment in another study that conflicts with the procedures or scientific integrity of this study
研究组 & 干预措施
Symptom-triggered diazepam treatment
Participants will be treated for a period of 3 days using a symptom-triggered withdrawal management protocol delivered over telemedicine. Participants who score 10 or above on the modified CIWA-Ar will be advised to take a specific dose of diazepam (either 10 or 20mg, at the clinician's discretion). Participants will be reassessed regularly over the 3-day period.
干预措施: Diazepam (Drug)
结局指标
主要结局
Retention in treatment
时间窗: 3-5 day treatment period
Retention in treatment, as measured by the percentage of participants who complete the entire 3-day remote withdrawal management protocol.
Transfer to a higher level of care
时间窗: 3-5 day treatment period
Transfer to a higher level of care, as measured by the percentage of participants sent to the emergency room due to complications, need for intensive monitoring, or acute intoxication.
次要结局
- Patient satisfaction with the treatment protocol(Measured within 1 week of completing the remote withdrawal procedure)
- Patient satisfaction with the telemedicine platform(Measured within 1 week of completing the remote withdrawal procedure)
- Diazepam dose(3-5 day treatment period)
- Duration of active withdrawal treatment(3-5 day treatment period)
- Requirement of benzodiazepines(3-5 day treatment period)
- Withdrawal severity(3-5 day treatment period)