MIVetsCan: Cannabis Coaching for Veteran Pain Management Trial (Phase 1)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Patient Global Impression of Change (PGIC) score
研究概览
简要总结
The goal of the MIVetsCan Can-Coach Trial is to pilot and modify a trial of four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms.
详细描述
All study interactions will be done virtually and recruitment data is exploratory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •United States Veteran
- •Experiencing chronic pain (pain lasting 3 or more months)
- •Worst pain of ≥3 out of 10 using a 0-10 Numeric Rating Scale (NRS)
- •Are planning or currently using cannabidiol (CBD) or cannabis products for pain management
- •Able to read and speak English sufficiently to allow for informed consent and active participation in the educational intervention sessions
- •Willingness to attend all study visits (conducted virtually)
- •Willingness to fill out periodic assessments via smartphone to assess symptom status and cannabis use (protocol has more details)
排除标准
- •Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English)
- •Participant states participant is pregnant
- •Current diagnosis or past history of a psychotic disorder (schizophrenia spectrum, except substance/medication -induced or due to another condition)
- •Current diagnosis or past history of bipolar disorder
- •Unable to attend study visits
- •Risk for eminent harm - Suicidal ideation or wish to die as assessed with the Positive and Negative Suicide Ideation (PANSI) questionnaire and further risk assessment by study team members
- •Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol
研究组 & 干预措施
Education
Prior to the educational sessions, study participants will be given access to educational materials (e.g., handouts, videos) that provide an overview of information regarding cannabis products, effects, and pain. These materials will be developed with insight from the study team and the Community Advisory Board.
Educational content will include known side effects of cannabis (e.g., common effects like dizziness or sedation, rare side effects like hallucinations or vomiting) as well as specific risks associated with administration routes, such as respiratory harm from smoking or unregulated vaporized concentrate products, and the delayed onset of edible products. Sessions will help the participants appropriately select products for use.
干预措施: Educational Session (Behavioral)
结局指标
主要结局
Patient Global Impression of Change (PGIC) score
时间窗: Week 14
Patient's Global Impression of Change (PGIC) scale will be used. This is a 7 point scale ranging from 1 (very much worse) to 7 (very much better).
次要结局
- Average satisfaction level of the cannabis coaching overall assessed from a single survey question on satisfaction.(Following intervention, up to approximately Week 14)
- Average helpfulness level of the cannabis coaching assessed from a single survey question on cannabis coaching.(Following intervention, up to approximately Week 14)
研究者
Kevin Boehnke
Research Assistant Professor, Anesthesiology
University of Michigan