Contact information
Type
Scientific
Primary contact
Dr Mark Adrian Ware
ORCID ID
Contact details
McGill University Health Centre
Pain Centre
Montreal General Hospital
Room E19.145
1650 Cedar Avenue
Montreal
Quebec
H3G 1A4
Canada
Type
Public
Additional contact
Ms Nicole Poitras
ORCID ID
Contact details
McGill University Health Centre
Pain Centre
Montreal General Hospital
Room E19.145
1650 Cedar Avenue
Montreal
Quebec
H3G 1A4
Canada
+1 (0)514 934 1934 ext: 44349
nicole.poitras@muhc.mcgill.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MOL-66262
Study information
Scientific title
Cannabis fOr Management of Pain: Assessment of Safety Study: COMPASS
Acronym
COMPASS
Study hypothesis
The rationale for this long-term follow-up safety study is to facilitate a better understanding of how patients use cannabis, the number and nature of side effects in relation to exposure, and it would allow some exploration of the effects of cannabis on certain symptoms. The information gathered will assist in policy decisions and inform discussions of cannabis use between patients and physicians.
Ethics approval
Research Ethics Committee of the McGill University Health Centre, Montreal General Hospital (Canada), 14/01/2004, ref: NREC#03-024
Study design
Multicentre two-arm open-label observational cohort safety study with one-year follow-up
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Chronic non-malignant pain
Intervention
Experimental group: cannabis, daily up to 3g/day
Control group: standard therapy for pain
Intervention type
Drug
Phase
Not Applicable
Drug names
Cannabis
Primary outcome measures
1. Adverse events and adverse drug reactions*:
Time of measurement: this will be reported by the subjects during interviews at clinic visits, during telephone contacts, or at any time by calling the local study nurse up to one year
2. Neurocognitive tests (Wechsler scales, for experimental arm [cannabis users] and control arm [non-cannabis users]):
Time of measurement: baseline, six months and one year
*An "adverse event" means any adverse occurrence in the health of a clinical trial subject who is administered a drug, which may or may not be caused by the administration of the drug, and includes an adverse drug reaction. An "Adverse Drug Reaction (ADR)" means any noxious and unintended response to a drug that is caused by the administration of any dose of the drug.
Secondary outcome measures
1. Satisfaction with the study drug: a global rating of change in patient satisfaction with the provided drug will be generated for subjects and physicians using the Clinician's Global Impression of Change (CGIC) scale. This is an observational scale of global evaluation, which assesses the changes in degree of illness in relation to the original assessment, not just due to the study drug. The scale has only one item that measures global change of the illness (improvement or worsening) by the clinician and by the patients, separately, on a seven-point scale from zero to six. Change in satisfaction on this scale will also be examined with other measures of satisfaction such as dropout rates
Time of measurement:
Experimental arm (cannabis users): one month, two months, three months, six months, nine months, one year
Control arm (non-cannabis users): six months, one year
2. Effects on symptoms and quality of life:
a. Pain intensity: effects on pain intensity will be recorded using 0 to 10 numerical rating scales (0: no pain, 10: worst)
b. McGill Pain Questionnaire (MPQ): pain quality will be recorded using the MPQ. The MPQ is a self-administered questionnaire that evaluates the sensory, affective, and evaluative dimensions of pain and provides global scores and subscale scores for each of these dimensions
c. Edmonton Symptom Assessment Scale (ESAS): other symptoms will be monitored using the validated ESAS. The ESAS evaluates eight symptoms on visual analogue scores
d. Profile of Mood States (POMS): the POMS was developed to assess transient distinct mood states and has become the most popular and widely used tool to assess mood
e. Quality of life will be followed using the 36-item Short Form health survey (SF-36): SF-36 is a generic measure of perceived health status that incorporates behavioural functioning, subjective well-being and perceptions of health by assessing eight health concepts
Time of measurement:
Experimental arm (cannabis users): baseline, one month, two months, three months, six months, nine months, one year
Control arm (non-cannabis users): baseline, six months, one year
3. Feasibility of web-based adverse event reporting: will be assessed by ongoing documentation of the study monitoring process, specifically recording the issues that may arise during data collection using web-based forms (errors, misunderstandings, etc.,) and the manner and success of their resolution
Overall trial start date
01/01/2005
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1400
Participant 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)
Recruitment start date
01/01/2005
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Canada
Trial participating centre
McGill University Health Centre
Quebec
H3G 1A4
Canada
Sponsor information
Organisation
McGill University Health Centre (Canada)
Sponsor details
Research Institute
1650 Cedar Ave
Montreal
Quebec
H3G 1A4
Canada
+1 (0)514 934 1934 ext: 44580
lynn.derycapes@muhc.mcgill.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26385201
Publication citations
-
Results
Ware MA, Wang T, Shapiro S, Collet JP; COMPASS study team, Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS), J Pain, 2015, doi: 10.1016/j.jpain.2015.07.014.