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Cannabis fOr Management of Pain: Assessment of Safety Study: COMPASS

Not Applicable
Completed
Conditions
Chronic non-malignant pain
Signs and Symptoms
Pain
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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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