Enhancing Prospective Thinking in Early Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 3
- 主要终点
- Future Self-Identification
研究概览
简要总结
The goal of this clinical trial is to demonstrate the commercial potential for a novel virtual reality (VR) intervention in preparation for Phase II development. This clinical trial will test the VR intervention for efficacy in reducing opioid use, increasing abstinence, and other self-reported and behavioral focus on future outcomes in individuals in early recovery from opioid use disorder.
- Will the VR group, compared to the control group, have a lower number of opioid use days?
- Will the VR group, compared to the control group, have longer periods of abstinence at the 30-day follow-up?
- Will the VR group, compared to the control group, have significantly increased opioid abstinence rates?
- Will the VR group, compared to baseline and the control group, show increased future self-identification post-VR intervention?
- Will the VR group, compared to baseline and the control group, show increased future orientation post-VR intervention?
- Will the VR group, compared to baseline and the control group, show an increased preference for delayed rewards in a laboratory delay discounting task post-VR intervention?
- Will the VR group, compared to baseline and the control group, exceed in behavioral effects (i.e., future self-identification, future orientation, and increased preference for delayed rewards) at the 30-day follow-up?
Researchers will compare the VR test group and the control group to see if there are differences in the results for the questions outlined above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
All study participants are randomly assigned to a group prior to study enrollment. Participants will not be made aware of their group assignment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Abstinence between ≥14 days and ≤ 1 year
- •18-60 years old
- •Verbal endorsement of commitment to recovery
- •Outpatient
- •Psychotropic drugs for SUD-comorbidity
- •Mu-Opioid drugs
- •Drug/alcohol abstinence ≥ 24 hours at the time of the study day visit
- •English comprehension
排除标准
- •Unstable medical disorders
- •Outside the age range of 18-60
- •Habitual drug use
- •Smell/taste disorders
- •Unstable psychiatric conditions
- •Extravagant/elaborate face tattoos
研究组 & 干预措施
Virtual Reality
Participants in this arm will receive the following interventions:
Virtual Reality Avatar VR plus Treatment As Usual (Intervention)
干预措施: Virtual Reality Avatar Intervention (Device)
Virtual Reality
Participants in this arm will receive the following interventions:
Virtual Reality Avatar VR plus Treatment As Usual (Intervention)
干预措施: Virtual Reality Empty Park (Device)
Sham VR (Control)
Participants in this arm will receive the following interventions:
Sham VR plus Treatment As Usual (Empty Virtual Reality Park)
干预措施: Virtual Reality Empty Park (Device)
结局指标
主要结局
Future Self-Identification
时间窗: Study Day Visit (Day 1); 30-day Follow-up Visit
The VR Avatar Experience will change future self-identification. Future self-identification and change between two time points will also be measured using a proprietary future-self-continuity assessment administered at Study Day Visit (Day 1), and again at the 30-Day Follow-up Visit.
Increased Length of Abstinence
时间窗: Study Day Visit (Day 1); 30-day Follow-up Visit.
The VR Avatar experience will change the length of abstinence periods.
Reduced Use of Drug Using Days
时间窗: Study Day Visit; 30-day Follow-up Visit.
The VR Avatar experience will change drug using days.
Delayed Reward
时间窗: Study Day Visit (Day 1); 30-day Follow-up Visit.
The Virtual Reality Avatar experience will change preference for delayed rewards, which will be measured using a behavioral delay discounting task.
Change in Overall Abstinence
时间窗: Study Day Visit (Day 1); 30-day Follow-up Visit.
The VR Avatar experience, compared to treatment as usual will change abstinence, measured using urine drug analysis, self report, and a timeline follow-back assessing for substances used from study day to study completion.
Future Time Orientation
时间窗: Study Day Visit (Day 1); 30-day Follow-up Visit.
The Virtual Reality Avatar experience will change orientation toward the future, which will be measured using the Zimbardo Time Perspective Inventory (ZTPI). The ZTPI contains five subscales, two of which will be administered and measured. Items within each subscale are scored from 1, "very uncharacteristic," to 5, "very characteristic." The subscales used are Present-Hedonistic--15 items, higher scores indicative of worse outcomes, and Future--10 items, higher scores indicative of better outcomes.
Reduced Number of Drug Using Days
时间窗: Study Day Visit; 30-day Follow-up Visit.
The VR Avatar experience will change drug using days.
Future Self-Continuity
时间窗: Study Day Visit (Day 1); 30-day Follow-up Visit
The VR Avatar Experience will change future self-continuity. Future self-continuity and change between two time points will also be measured using a proprietary future-self-continuity assessment administered at Study Day Visit (Day 1), and again at the 30-Day Follow-up Visit.
次要结局
未报告次要终点
研究者
Brandon G. Oberlin, PhD
Assistant Professor
Indiana University