NCT05591703已完成不适用
Clinical Outcomes Following Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention: A Long-term Follow-up Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Proportion of participants in Phase II with a relapse event
研究概览
简要总结
This is a prospective, observational, longitudinal study to assess clinical outcomes in the 12-months following participants' exit from protocol SBM-OWP-03, Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder (RESTORE; ClinicalTrials.gov Identifier: NCT05053503). Clinical outcome scores will be collected at study exit from protocol SBM-OWP-03, 1 month, 3 months, 6 months, 9 months, and 12 months after study exit from protocol SBM-OWP-03.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- 否
入选标准
- •Consented participant for protocol SBM-OWP-03, Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder (RESTORE)
- •Participant is English proficient
- •Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
排除标准
- •Participant is unable to reliably receive and respond to assessments via email or telephone
- •Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
结局指标
主要结局
Proportion of participants in Phase II with a relapse event
时间窗: 12 months (total duration of trial)
次要结局
- Mean change in recovery capital measured by Brief Assessment of Recovery Capital (BARC-10)(Baseline to Study Completion (12 months))
- Proportion of participants in either Phase I or Phase II with a relapse event(12 months (total duration of trial))
- Mean change in anxiety across time measured by Generalized Anxiety Disorder (GAD-7)(Baseline to Study Completion (12 months))
- Mean change in opioid craving measured by the Opioid Craving Scale (OCS)(Baseline to Study Completion (12 months))
- Mean change in Quality of Life across time measured by World Health Organization Quality of Life(WHOQOL-BREF) domain scores(Baseline to Study Completion (12 months))
- Mean change in Commitment to Sobriety Scale (CSS-5)(Baseline to Study Completion (12 months))
- Mean change in PTSD symptoms across time measured by the PTSD Checklist for DSM-5 (PCL-5)(Baseline to Study Completion (12 months))
- Mean change in depression symptoms across time measured by Patient Health Questionnaire (PHQ-9)(Baseline to Study Completion (12 months))
- Mean change in protracted withdrawal symptoms measured by the Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)(Baseline to Study Completion (12 months))
研究者
研究点 (2)
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