NIDA CTN Protocol 0150: Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD: A Pilot Randomized Trial (TOME Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 12
- 主要终点
- Medication for Opioid Use Disorder (MOUD) Knowledge Score
研究概览
简要总结
The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons.
详细描述
This is an intent-to-treat, two-arm, open-label, randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to TOME or Control, balancing on site. Participants will receive the assigned intervention following randomization and will complete a three week follow-up assessment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Potential participants must be:
- •18 years of age or older;
- •Pregnant or be within 12 months postpartum;
- •Enrolled in MOUD (either buprenorphine or methadone) at the study site or affiliated clinic where enrollment can be confirmed;
- •Able to understand the study, and having understood, provide written informed consent in English
排除标准
- •Potential participants must not:
- •have suicidal or homicidal ideation requiring immediate attention.
结局指标
主要结局
Medication for Opioid Use Disorder (MOUD) Knowledge Score
时间窗: Week 3
This outcome is measured by the Opioid Overdose and Treatment Awareness Survey (OOTAS) knowledge evaluation: MOUD knowledge, potential score of 0-10; higher score indicates more knowledge. Values are converted to a percentage of correct answers from 0-100% where higher percentages mean more knowledge.
Opioid Overdose Knowledge Score
时间窗: Week 3
This outcome is measured by the first three sections of the Opioid Overdose and Treatment Awareness Survey (OOTAS). Opioid-overdose knowledge, potential score of 0-31; higher score indicates more knowledge. Values are converted to a percentage of correct answers from 0-100% where higher percentages mean more knowledge.
次要结局
- Medication for Opioid Use Disorder (MOUD) Internalized Stigma(Week 3)
- Drug Self-efficacy(Week 3)
研究者
T. John Winhusen, PhD
Professor; Vice Chair and Division Director of Addiction Sciences
University of Cincinnati