Antidepressants During Office-Based Buprenorphine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Dropped Out of Buprenorphine Treatment
研究概览
简要总结
This study is designed to test whether treatment of depressive symptoms using escitalopram improves adherence to Buprenorphine and reduces symptoms of depression for individuals receiving Buprenorphine through their medical provider.
详细描述
Participants interested in receiving Buprenorphine will be offered the opportunity to enroll in this study. Enrolled study participants will complete interviews at baseline and again every two weeks for a total of 8 interviews over 3 months. In this double-blind randomized controlled trial, participants will either receive a placebo or escitalopram (10mg). All participants will also be followed by their Buprenorphine clinic medical provider. Questions during the face-to-face interviews will assess mood, drug craving, pain, sleep, medication adherence and drug-related experiences. Comparison(s): Participants randomized into the medication component of the study as compared to participants randomized into the placebo component of the study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •opiate dependence
- •Ham-D > 14
排除标准
- •no psychiatric contraindications to using escitalopram
- •no medical contraindications to using escitalopram
- •methadone dose < 30
- •no current SSRI use
研究组 & 干预措施
placebo
干预措施: placebo (Drug)
escitalopram
干预措施: escitalopram (Drug)
结局指标
主要结局
Percentage of Participants Who Dropped Out of Buprenorphine Treatment
时间窗: 3 months
Drop-out is defined as 7 or more days of missed Buprenorphine doses
次要结局
- Depressive Symptoms(3 months)
研究者
Michael Stein, MD
Principal Investigator
Butler Hospital