Ketamine Assisted Psychotherapy for Opioid Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Drug use
研究概览
简要总结
This pilot clinical trial aims to assess the preliminary efficacy of ketamine as an adjunct for a mindfulness-based intervention for opioid use disorder.
详细描述
The purpose of this study is to conduct a Stage 1 randomized controlled trial to test a potential optimization of the evidence-based Mindfulness-Oriented Recovery Enhancement (MORE) intervention for opioid use disorder (OUD). Here we will add Ketamine to MORE (MORE+KAP) and test the MORE+KAP intervention versus the standard MORE intervention in a sample of patients receiving medications for OUD (MOUD; e.g, buprenorphine). The primary aim to is evaluate the extent to which MORE+KAP improves OUD treatment relative to MORE. The secondary aim is to identify the psychobiological mediators of MORE+KAP.
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 (Investigator, Outcomes Assessor)
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
- •Diagnosis of Opioid Use Disorder
- •Receiving OUD treatment with a buprenorphine formulation
排除标准
- •Previous experience with a mindfulness-based intervention program
- •Any serious medical, mental, or cognitive issue that prevents successful participation in a mindfulness-based group treatment program
- •Prior use of ketamine other than as prescribed by a physician
- •Any of the following medical conditions
- •Blood Vessel Disease Heart Valve Disease Heart Failure Class 2 or Above Heart Disease Pregnancy/Breastfeeding Arteriovenous Malformation History of Intracranial Bleeding or Stroke History of Seizures Hypoxia defined by current need for supplemental oxygen Liver Disease History of allergic reaction to Ketamine Dementia (moderate-severe) History of Psychotic Disorder, Bipolar Disorder, or Personality Disorder Dissociative Identity Disorder
结局指标
主要结局
Drug use
时间窗: From baseline to 3-month follow-up
Days of drug use as measured by the Timeline Followback Procedure
次要结局
- Meaning in life(From baseline to 3-month follow-up)
- Opioid craving(From baseline to 3-month follow-up)
- Self-transcendence(From baseline to 3-month follow-up)
- Affect(From baseline to 1-month follow-up)
- Reappraisal(From baseline to 3-month follow-up)
- MOUD use(From baseline to 3-month follow-up)
- Emotional Distress(From baseline to 3-month follow-up)
- Mindfulness(From baseline to 3-month follow-up)
- Savoring(From baseline to 3-month follow-up)
- Momentary craving(From baseline to 1-month follow-up)
研究者
Eric Garland
Professor
University of Utah