Project summary

Title

The Quebec cannabis registry: A Database on the Use of Dried Cannabis for Medical Purposes Established for Research Purposes

Rationale/background

Since April 1st 2014, legal access to dried cannabis has been made possible through the new Marijuana for Medical Purposes Regulations (MMPR). Despite decisions handed down by Canadian courts, and the existence of medical cannabis access programs, the product in its dried form is not a recognized medical treatment. Consequently, the coming into force of these regulations obliges the medical profession to prescribe the product outside the usual framework for prescription drugs and without the conclusive scientific data required to ensure good medical practices.

Faced with this unique and unprecedented situation, which has certain risks for patients and possible forensic implications for prescribing physicians, the Collège des médecins du Québec (CMQ) has proposed a special framework based on prudence and aimed at reconciling regulatory compliance with the protection of patient health and well-being. Consequently, and in accordance with their code of professional ethics, physicians are not required to prescribe dried cannabis, and, since April 1, 2014, those who agree to prescribe it can only do so within a research framework.

General description

The database on the use of dried cannabis for medical purposes established for research purposes aims to assemble and preserve, for research purposes, clinical data collected from users of dried medical cannabis. The research data could be made available to researchers in Quebec and elsewhere and, in accordance with specific criteria, from other organizations seeking to undertake research projects aimed at developing new knowledge on dried medical cannabis use.

Primary objective

  1. To establish an infrastructure for research aimed at producing new knowledge on dried medical cannabis use, and specifically studies on its potential risks and benefits.

Secondary objectives

  1. To implement out a scientific mechanism to generate new research questions on the subject.
  2. To foster collaboration among researchers conducting projects on cannabinoid use, from Quebec, and possibly other Canadian provinces, the United States and elsewhere, by giving them a means to share research data.

Specifications

The database on the use of dried cannabis for medical purposes established for research purposes will be based on the planned collection of observational data for a total of 10 years, with collection of clinical data for 4 years following the recruitment of each participant.

Population

The database on the use of dried cannabis for medical purposes established for research purposes will be constituted from the clinical data of participants to whom a physician-collaborator in this research project who practices in Quebec has prescribed dried medical cannabis, in accordance with the regulatory and methodological directives of the Collège des médecins du Québec and its collaborators.

Planned study population

It is expected to include 3000 participants, who will be recruited over a period of 10 years (May 2015 - May 2025).

Mode of recruitment

Quebec physicians will be asked to recruit participants from among those to whom they are contemplating prescribing dried medical cannabis.

Inclusion criteria

  • Males or females aged 18 and over
  • Receiving a prescription for dried medical cannabis
  • Capable of consenting
  • Capable of completing the questionnaires

Exclusion criteria

  • Person who refuses to participate
  • Person who is incapable of consenting

Procedures

With the collaboration of the physician-collaborators, all patients who meet the inclusion criteria will be asked to participate. The physician-collaborators will inform prospective participants of the current clinical data and the limitations of these data and of the need to carry out more long-term research on the use of dried medical cannabis. They will indicate to the prospective participants that dried cannabis is not a treatment approved by Health Canada and that consequently it cannot be prescribed in Quebec outside a research framework. The prospective participants will then be asked by the physician-collaborators to take part in the creation of the database. They will receive relevant information from their physician-collaborators and will also receive information and consent form. They will also be able to contact a member of the research team if they have any questions about the research project. They will be able to take the time to decide before giving their free and informed consent.

Assessment measures and instruments

Paper version: Initial questionnaire Follow-up questionnaires (every 3 months for 2 years; once a year for the last two years)

Data management

All data collected from the questionnaires will be entered in REDCap (Research Electronic Data Capture) to constitute the electronic database. Entry of the de-identified data will be performed by the study coordinator or by any other person authorized to enter the data, under the cover of confidentiality.