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Does Medical Cannabis Reduce Opioid Use in Adults With Pain

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赞助商
Albert Einstein College of Medicine
合作者
Laura and John Arnold Foundation
Vireo Health

关键词

抽象

The study will examine how medical cannabis use affects opioid analgesic use. This landmark study will be among the first to examine the effect of medical cannabis with different THC/CBD content on opioid use as well as adverse events.

描述

This study will examine how medical cannabis use affects opioid analgesic use, with particular attention to THC/CBD content and adverse events. We will enroll adults with (a) severe or chronic neuropathic or joint pain, (b) prescribed opioid analgesic use, (c) new certification for medical cannabis, and (d) newly dispensed soft gel capsule products from Vireo (medical cannabis dispensary) (including a high THC:low CBD product, an equal THC:CBD product, and a low THC:high CBD product). Over the 14 weeks, data sources will include questionnaires; medical, pharmacy, and Prescription Monitoring Program (PMP) records; and urine samples. The primary independent variable will be type of soft gel capsule product, and the primary outcome will be cumulative opioid analgesic dose.

日期

最后验证: 06/30/2020
首次提交: 03/11/2020
提交的预估入学人数: 03/11/2020
首次发布: 03/12/2020
上次提交的更新: 07/15/2020
最近更新发布: 07/16/2020
实际学习开始日期: 07/30/2020
预计主要完成日期: 12/30/2022
预计完成日期: 12/30/2022

状况或疾病

Opioid Use
Marijuana
Chronic Pain

-

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
取样方式Non-Probability Sample
接受健康志愿者
标准

Inclusion Criteria:

- At least 18 years of age

- English or Spanish fluency

- New certification for medical cannabis within 90 days

- No medical cannabis dispensed or used within the previous 6 months

- New soft-gel capsule product dispensed at Vireo

- Medical cannabis qualifying conditions or complications of "chronic or severe pain" or "pain that degrades health and functional capability as an alternative to opioid use or substance use disorder"

- Joint or neuropathic pain

- Current severe pain

- Dispensed opioid analgesics within the last 30 days

- Self-reported use of opioid analgesics

Exclusion Criteria:

- Inability to provide informed consent

- Inability to complete study visits over 14 weeks

- Qualifying conditions for medical cannabis in NY that are likely to cause unique pain syndromes

- Terminal illness

- Current or prior psychotic disorder

- Current or prior buprenorphine or methadone treatment for opioid use disorder

- Allergies to tapioca or coconut

结果

主要结果指标

1. Opioid analgesic use [Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.]

The primary outcome will be opioid analgesic use.

次要成果指标

1. Adverse events [Adverse events will be over 14 weeks]

(e.g. Cannabis use disorder, illicit drug use, diversion of medical cannabis, accidents and injuries)

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