Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: Follow-up of a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Alcohol intake
研究概览
简要总结
This study is an assessment of the long-term effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol after 60 days and 1 year. It is a follow-up study of a placebo-controlled randomized controlled study where subjects used oxytocin nasal spray during acute withdrawal and the following 4 weeks in an outpatient setting. Half of the participants have received oxytocin nasal spray, the other half placebo nasal spray (NCT02903251). (added March 2019: 24 patients were available for 1-year follow-up)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •participants in the RCT (NCT02903251) who completed the study
排除标准
- •participants in the RCT (NCT02903251) who did not complete the study
研究组 & 干预措施
oxytocin
intranasal oxytocin spray Day 1-3: Twice daily intranasal oxytocin spray administered by health personnel.
Day 3-30:Self-administered intranasal spray as needed, max thrice daily
干预措施: intranasal oxytocin spray (Drug)
Placebo
intranasal spray without oxytocin Day 1-3: Twice daily intranasal spray without oxytocin, administered by health personnel.
Day 3-30: Self-administered intranasal spray as needed, max thrice daily
干预措施: intranasal spray without oxytocin (Other)
结局指标
主要结局
Alcohol intake
时间窗: 1 year
using the Timeline Follow-back method and phosphatidylethanol (PEth) blood test
次要结局
- Number of rehospitalisations and readmissions to treatment for substance use disorders(1 year)
- Sleep(1 year)