Effects of intranasal oxytocin in the treatment of benzodiazepine withdrawal: A pilot randomized parallel group placebo-controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study is measuring BZD withdrawal symptoms to see if OT administered intranasally in addition to traditional dose tapering is more effective than BZD tapering and placebo. CIWA-B is a well-known and well-used 20-item questionnaire for BZD withdrawal symptoms where each item can be assigned a score from 0 to 4, i.e. the total score can range between 0-80 points. Based on previous studies a 3.5-point difference is considered clinically relevant.
研究概览
简要总结
The primary aim of the study is to test whether there is a difference between daily intranasal administration of oxytocin or placebo for 21 days added to a dose reduction regime of diazepam in benzodiazepine withdrawal symptoms. Benzodiazepine withdrawal symptoms severity is measured with CIWA-B score, a 20-item scale where each item can be assigned a score from 0 to 4, i.e. the total score can range from 0 and 80 points. CIWA-B score will be measured daily from baseline (i.e. the day before the intervention starts) to day 21. Change in CIWA-B from baseline to day 21 will compared between the two groups.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 – 65 years, taking BZDs at a daily dose of 20-80 mg diazepam-equivalent, and requiring inpatient BZD withdrawal. Included patients must consent to participate in the study.
排除标准
- •Female patients will be excluded if they are pregnant or are planning to become so, or if they are breast-feeding. Individuals incapable of completing questionnaires or giving informed consent will be excluded. Patients with concurrent acute medical or psychiatric illness requiring acute care hospitalization, misuse or dependency of alcohol or pregabalin/gabapentin will be excluded.
结局指标
主要结局
The primary endpoint of the study is measuring BZD withdrawal symptoms to see if OT administered intranasally in addition to traditional dose tapering is more effective than BZD tapering and placebo. CIWA-B is a well-known and well-used 20-item questionnaire for BZD withdrawal symptoms where each item can be assigned a score from 0 to 4, i.e. the total score can range between 0-80 points. Based on previous studies a 3.5-point difference is considered clinically relevant.
The primary endpoint of the study is measuring BZD withdrawal symptoms to see if OT administered intranasally in addition to traditional dose tapering is more effective than BZD tapering and placebo. CIWA-B is a well-known and well-used 20-item questionnaire for BZD withdrawal symptoms where each item can be assigned a score from 0 to 4, i.e. the total score can range between 0-80 points. Based on previous studies a 3.5-point difference is considered clinically relevant.
次要结局
- Hamilton Anxiety and Depression Scale (HAD), Insomnia Severity Index (ISI) and actigraphy and Somnofy assessed akathisia and sleep.
研究者
Tone Aurora Pleym
Scientific
St. Olavs Hospital HF