NCT06283862招募中不适用
MIVetsCan: Cannabis Coaching for Veteran Pain Management Trial (Phase 2)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 468
- 试验地点
- 1
- 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 test 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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)
- •Moderate to severe chronic pain
- •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
- •Planning to move out of a state with legal recreational marijuana use during course of study;
- •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 imminent 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
Immediate Education
Experimental
Education sessions starting ~ week 4 of trial
干预措施: Educational Session (Behavioral)
Waitlist Control - delayed education
Other
Education sessions starting ~ week 12 of trial
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: Up to 14 weeks
次要结局
- Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Positive ideation(Up to 14 weeks)
- Anxiety as measured by the score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile version 2.1(Up to 14 weeks)
- Self-report of pain (intensity or severity) from a numerical rating scale of 0-10(Up to 14 weeks)
- Pain interference trends as measured by the score on the PROMIS-29 Profile version 2.1(Up to 14 weeks)
- Sleep disturbance as measured by the score on the PROMIS-29 Profile version 2.1(Up to 14 weeks)
- Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Negative ideation(Up to 14 weeks)
研究者
Kevin Boehnke
Assistant Professor, Anesthesiology
University of Michigan
研究点 (1)
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