Cannabis fOr Management of Pain: Assessment of Safety Study: COMPASS
- Conditions
- Chronic non-malignant painSigns and SymptomsPain
- Registration Number
- ISRCTN19449752
- Lead Sponsor
- McGill University Health Centre (Canada)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1400
Experimental arm and control arm (common criteria):
1. Adults 18 years or older, either sex
2. Chronic non-cancer pain for six months or longer
3. Moderate to severe pain (average weekly pain score on a 0 to 10 point scale of 5 or greater)
4. Ability to comply with protocol requirements
5. Proficient in reading and writing in English or French
6. Patient willing and able to give informed consent
Specific criteria (in addition to common criteria):
1. Experimental arm: conventional treatments have been considered medically inappropriate or inadequate
2. Control arm: patients must have received any prescription from the study physician in the past three months
Experimental arm and control arm (common criteria):
1. Pregnant or breast-feeding women
2. History of psychosis, including mental illness that could put subjects at risk during the study
3. Significant and unstable ischaemic heart disease or arrhythmia
4. Significant and unstable bronchopulmonary disease
5. Discordance between self-reported drug use and urine drug screening
6. History of drug dependency (including cannabis), or at risk of drug dependency identified by Drug Abuse Screening Test (DAST) and urine drug testing
7. Concurrent involvement in other clinical trial(s)
Specific criteria (in addition to common criteria):
1. Control arm: current cannabis use (use in the past month)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method