Development of an Opioid Withdrawal Clinical Outcome Assessment Among Persons With Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Cognitive interview
研究概览
简要总结
Withdrawal management strategies are currently the most utilized and ubiquitous intervention for opioid use disorder in the US, yet existing measures of opioid withdrawal lack Food and Drug Administration (FDA) qualification. This project will develop and validate a clinical outcome assessment (COA) for opioid withdrawal,essential for standardizing withdrawal mitigation strategies and establishing best practices. In line with the FDA's drug development tool qualification guidelines, our methodological process will involve conducting focus groups with persons with lived experience of opioid withdrawal for concept elicitation, refining these concepts through cognitive interviews, and conducting construct and longitudinal validations of the new assessment in laboratory settings and across diverse treatment contexts.
详细描述
Participants with opioid use disorder will complete a two sessions in a within-subject study design to compare their responses to withdrawal questions after experiencing naloxone-precipitated withdrawal and following an overnight observation of spontaneous withdrawal. All participants will complete both sessions and the order of sessions will be randomized.
The primary outcome will be cognitive interviews, which will be conducted within 8 hours of each observation period ending to query all possible symptoms associated with the withdrawal experience.
Participants will be offered referrals to aftercare prior to study discharge and transitions to treatment programs will be facilitated whenever possible.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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
- •Past year opioid use disorder, determined by (a) enrollment in current treatment for opioid use disorder and/or (b) an opioid-positive saliva test.
- •Fluent in English
- •Has experience with opioid withdrawal at least once in the past 30 days
排除标准
- •Unable to provide informed consent due to cognitive impairment
- •Being pregnant or breastfeeding
- •History of psychosis or mania as determined by the MINI
- •Exhibiting suicidal behavior in the past 30 days as determined by the C-SSRS
- •Circumstances that could interfere with study participation
- •Previously participated in affiliated Focus Group study
研究组 & 干预措施
WIthdrawal assessment_precipitated session
Assessment of withdrawal following elicitation
Withdrawal assessment_spontaneous
Assessment of withdrawal during a period of opioid abstinence
结局指标
主要结局
Cognitive interview
时间窗: Within 8 hours of completing the withdrawal experience
The experience of withdrawal will be probed qualitatively using cognitive interviews to capture all possible symptoms that opioid withdrawal may elicit in an individual
次要结局
未报告次要终点
研究者
Kelly Dunn
Director, Kahlert Institute for Addiction Medicine
University of Maryland, Baltimore