Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder: A Phase 2 Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- BehaVR LLC
- 入组人数
- 128
- 试验地点
- 4
- 主要终点
- Days of opioid use
研究概览
简要总结
The goal of this clinical trial is to examine the usefulness of a virtual reality-delivered intervention for individuals with opioid use disorder who are taking medication. The main question it aims to answer is will people with opioid use disorder who receive the study intervention, Mindfulness-Oriented Recovery Enhancement in Virtual Reality (MORE-VR), have fewer days in which they use opioids than will people who just receive their usual treatment. Participants will be randomly assigned to either receive 8 weekly sessions of MORE-VR in addition to their usual treatment, or treatment as usual only. Researchers will compare these groups at the end of treatment and three months after treatment is over on number of days of opioid use and time until first opioid use lapse, as well as drug craving and mood.
详细描述
This project is a Phase II, two-arm, parallel randomized controlled trial (RCT) of a virtual reality form of Mindfulness-Oriented Recovery Enhancement (MORE-VR) versus treatment as usual (TAU) for patients receiving medications for opioid use disorder (MOUD) to assess the efficacy of the MORE-VR system. Participants will be randomized (1:1) to either 8 weekly sessions of MORE-VR or TAU. Participants will be assessed at intake, post-treatment, and a 3 month post-treatment follow-up. The primary outcome assessed will be days of opioid use.
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
- Single (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
- •18 years of age or older
- •current DSM-5 OUD diagnosis
- •prescribed medications for opioid use disorder (e.g., buprenorphine, methadone)
排除标准
- •completion of a standardized mindfulness intervention (e.g., MORE, MBRP, MBSR)
- •active psychosis or suicidality
- •reports, or is noted by clinical or study staff as showing cognitive impairment
- •condition which might be contraindicated for VR use including seizure disorder, vertigo, severe motion sickness, recent concussion
结局指标
主要结局
Days of opioid use
时间窗: Baseline to post-treatment assessment (8 weeks)
Days of opioid use assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen
次要结局
- Days of opioid use at follow-up(Baseline to 3 months post treatment (20 weeks from baseline))
- Time until opioid lapse(Baseline through 3 month post-treatment follow-up)
- Positive Affect(Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period)
- Health-related Quality of Life(Baseline through 3 month post-treatment follow-up)
- Distress(Baseline through 3 month post-treatment follow-up)
- Time until dropout from opioid use disorder treatment(Baseline through 3 month post-treatment follow-up)
- Opioid craving(Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period)
- Desire for drugs(Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period)
- Negative Affect(Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period)
- Positive and Negative Affect Schedule(Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period)