Cannabis Oil for Chronic Non-Cancer Pain Treatment
关键词
抽象
日期
最后验证: | 10/31/2018 |
首次提交: | 08/14/2018 |
提交的预估入学人数: | 08/14/2018 |
首次发布: | 08/16/2018 |
上次提交的更新: | 11/07/2018 |
最近更新发布: | 11/12/2018 |
实际学习开始日期: | 12/31/2018 |
预计主要完成日期: | 01/29/2021 |
预计完成日期: | 01/29/2021 |
状况或疾病
干预/治疗
Drug: CBD
Drug: CBD+THC
Other: Placebo
相
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: CBD 10mg capsules Cannabidiol (CBD) | Drug: CBD Participants will be randomized to CBD 10mg capsules for 12 weeks. Participants will start with 1, CBD (10mg) capsule per day and self-titrate up to 8, 10mg CBD capsules (80mg) per day as needed. |
Active Comparator: CBD+THC 10mg capsules Cannabidiol (CBD) +THC tetrahydrocannabinol (CBD 5mg + (THC) | Drug: CBD+THC Participants will be randomized to CBD+THC 10mg (CBD 5mg + THC) for 12 weeks. Participants will start with 1, 10mg CBD+THC (5mg+5mg) capsule per day and self- titrate up to 8, 10mg CBD+THC (5mg+5mg) capsules to a maximum of 80mg (40mg CBD + 40mg THC) per day as needed. |
Placebo Comparator: Placebo 10mg capsules placebo | Other: Placebo Participants randomized to placebo 10mg capsules for 12 weeks. Participants will start with 1, 10mg placebo capsule per day and self-titrate up to 8 10mg placebo capsules (80mg) per day. |
资格标准
有资格学习的年龄 | 26 Years 至 26 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Age >25 - Average pain score in past week of ≥ 4/10. Exclusion Criteria: - Personal history of bipolar disorder - Personal or family history (first degree relative - parent of sibling) of psychotic disorders (e.g., schizophrenia) - Active cancer (an individual undergoing active cancer chemotherapy, radiation or surgical treatment and is deemed to not be in remission as per an oncologist's report) - Intention to travel internationally during the trial - Uncontrolled diabetes (A1C > 11) - Cannabis use in the past 4 weeks (recreational or medicinal) - Current use of illicit drugs (e.g., cocaine) - Current use of non-prescription opioids - Unable to read and write in English - Women who are currently pregnant or breast-feeding; or women of child-bearing age who plan to become pregnant during the trial period. |
结果
主要结果指标
1. Average Pain Score [12 weeks after Treatment (Week 16 of trial)]
次要成果指标
1. Pain Severity Score [Baseline, week 4, 8, 12 and 16]
2. Pain Intensity Score [Baseline, week 4, 8, 12 and 16]
3. Physical Functioning Score [Baseline, week 4, 8, 12 and 16]
4. Mental Health Score [Baseline, week 4, 8, 12 and 16]
5. Social Functioning Score [Baseline, week 4, 8, 12 and 16]
6. Physical Health-related Role Limitations [Baseline, week 4, 8, 12 and 16]
7. Depression Score [Baseline, week 4, 8, 12 and 16]
8. Anxiety Score [Baseline, week 4, 8, 12 and 16]
9. Sleep Quality [Baseline, week 4, 8, 12 and 16]
10. Pain Medication [Baseline, week 4, 8, 12 and 16]
11. Other non-pain prescription medications [Baseline, week 4, 8, 12 and 16]
12. Average Pain Score [Baseline, week 4, 8 and 12]