MEMO-Medical Marijuana and Opioids Study
关键词
抽象
描述
The overarching goal of the study is to understand how medical cannabis use affects opioid analgesic use over time, with particular attention to THC/CBD content, HIV outcomes, and adverse events. The study will include a cohort of 250 HIV+ and HIV- adults with (a) severe or chronic pain, (b) opioid analgesic use, and (c) new certification for medical cannabis. Over 18 months, participants will have 7 in-person visits every 3 months and 39 web-based questionnaires every 2 weeks. Data sources will include questionnaires; medical, pharmacy, and Prescription Monitoring Program records; and urine and blood samples. Over each 2-week time period (unit of analysis), the primary exposure measure will be number of days of medical cannabis use, and the primary outcome measure will be cumulative opioid analgesic dose. Qualitative interviews will also be conducted with a subgroup of 30 participants to explore perceptions of how medical cannabis use affects opioid analgesic use. Qualitative findings will help understand the reasons underlying the findings of the cohort study.
日期
| 最后验证: | 04/30/2020 |
| 首次提交: | 08/22/2017 |
| 提交的预估入学人数: | 08/28/2017 |
| 首次发布: | 08/30/2017 |
| 上次提交的更新: | 05/03/2020 |
| 最近更新发布: | 05/04/2020 |
| 实际学习开始日期: | 09/03/2018 |
| 预计主要完成日期: | 06/29/2022 |
| 预计完成日期: | 06/29/2022 |
状况或疾病
相
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 | 是 |
| 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 use in the 6 months prior to certification - Medical cannabis qualifying complication of "chronic or severe pain" - Use of prescribed or illicit opioid analgesics within 30 days Exclusion Criteria: - Inability to provide informed consent - Inability to complete study visits over 18 months - Qualifying conditions for medical cannabis in NY that are likely to cause unique pain syndromes (cancer, epilepsy, multiple sclerosis, spinal cord injury, amyotrophic lateral sclerosis, Parkinson's disease, inflammatory bowel disease, Hungtington's disease) - Terminal illness - Current or prior psychotic disorder |
结果
主要结果指标
1. Opioid analgesic use [Opioid analgesic use will be a cumulative dose of all opioid analgesics over each of the 39 2-week periods.]
次要成果指标
1. Alternative measures of opioid analgesic use [Alternative measures of opioid analgesic use will be measured over each of the 39 2-week periods.]
2. HIV viral load [HIV outcomes will be measured seven times every 3 months from baseline through 18 months.]
3. CD4 count [CD4 count will be measured seven times every 6 months from baseline through 18 months..]
4. HIV antiretroviral adherence [HIV antiretroviral adherence will be measured seven times every 3 months from baseline through 18 months..]
5. HIV risk behaviors [HIV risk behaviors will be measured seven times every 3 months from baseline through 18 months..]
6. Cannabis use disorder [Cannabis use disorder will be measured three times every 6 months.]
7. Illicit drug use [Illicit drug use will be measured seven times every 3 months from baseline through 18 months..]
8. Diversion of medical cannabis [Diversion will be measured seven times every 3 months from baseline through 18 months..]
9. Non-fatal overdose [Non-fatal overdose will be measured seven times every 3 months from baseline through 18 months..]
10. Death [Death will be measured 18 months after enrollment.]
11. Accidents/Injuries [Accident/Injuries will be measured seven times every 3 months from baseline through 18 months..]
