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
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Benzodiazepine withdrawal symptoms
研究概览
简要总结
The goal of this clinical trial is to learn if oxytocin administered as a nasal spray will reduce withdrawal symptoms in adults during benzodiazepine tapering for 21 days. It will also learn about the safety of oxytocin. The main questions it aims to answer are:
Does oxytocin reduce benzodiazepine withdrawal symptoms and make it easier to succeed tapering? Does oxytocin help reduce sleep difficulties and anxiety or restlessness during benzodiazepine tapering? Does oxytocin help reduce benzodiazepine craving?
We will compare oxytocin nasal spray to a placebo nasal spray containing regular saline to see if oxytocin works accordingly.
Participants will:
Take oxytocin or a placebo nasal spray, three times daily for 21 days during inpatient benzodiazepine tapering.
Fill out an online questionnaire every day and keep a record of their symptoms.
详细描述
Background Benzodiazepine withdrawal can be challenging, often accompanied by severe anxiety, insomnia, and other withdrawal symptoms. Recent studies suggest that intranasal oxytocin (OT) may have anxiolytic properties and could potentially ease withdrawal symptoms. This study aims to evaluate the efficacy and safety of intranasal OT in the treatment of benzodiazepine withdrawal.
Objectives The primary objective is to evaluate if intranasal OT can reduce withdrawal symptoms in patients during benzodiazepine tapering. Secondary objectives include evaluating the safety and tolerability of intranasal OT and its impact on anxiety levels and sleep quality.
Methods
- Design: This is a randomized, parallel-group, placebo-controlled trial.
- Participants: Adults (aged 18-65) undergoing inpatient benzodiazepine tapering.
- Intervention: Participants were randomly assigned to receive either intranasal OT (16 IU per administration, given three times daily, for a total daily dose of 48 IU) or placebo for 21 days during inpatient benzodiazepine tapering.
- Assessments: Withdrawal symptoms were measured using the Clinical Institute Withdrawal Assessment for Benzodiazepines (CIWA-B) scale. Anxiety and depression symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS), and sleep was measured using the Insomnia Severity Index (ISI), actigraphy, and Somnofy.
Procedure
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 四盲 (受试者、医护人员、研究者、结局评估者)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Patients aged 18 - 65 years, taking benzodiazepines at a daily dose of 20-80 mg diazepam-equivalent, and requiring inpatient benzodiazepine 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.
研究组 & 干预措施
Placebo
Participants in the placebo arm will receive a saline solution. Saline is an inert substance, meaning it has no therapeutic effect, making it an ideal placebo. The saline solution will be administered in the same manner as the experimental treatment. The treatment is administered intranasally. The treatment is blinded. Neither the participants nor the researchers know who is receiving the placebo and who is receiving the active treatment. Participants in the placebo arm will be monitored the same as those in the treatment arm. Participants will be fully informed about the possibility of receiving a placebo and will provide informed consent. The same outcome measures will be used for both the placebo and treatment arms.
干预措施: Saline (NaCl 0,9 %) (placebo) (Drug)
Oxytocin
Participants in this arm will receive intranasal oxytocin. The dosage and administration schedule will be consistent with the study protocol. Participants will receive 48 international units (IU) of oxytocin. The oxytocin will be administered intranasally using a nasal spray. Participants will insert the nasal spray container approximately 1 cm into each nostril and spray. They will wait 15 seconds before repeating administration until they have received a total of 4 puffs (2 in each nostril) per session thrice daily.
干预措施: Oxytocin nasal spray (Drug)
结局指标
主要结局
Benzodiazepine withdrawal symptoms
时间窗: 21 days
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.
次要结局
- Benzodiazepine craving(21 days)
- Benzodiazepine anxiety and depression symptoms(21 days)
- Benzodiazepine tapering "freezes"(21 days)
- Benzodiazepine sleep distress(21 days)
研究者
研究点 (2)
标识符
- NCT 编号
- NCT06757517
- 其他研究编号
- 32672, 2024-516262-11-00, 2019-002280-10, 2019
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (10个月前)
- 研究完成日期
- (8个月前)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否