MedTrace Logo

Safety and Efficacy of Medical Cannabis Oil in the Treatment of Patients with Chronic Pain

NCT03337503 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2024-12-02

No results posted yet for this study

Summary

Seeking for effective therapeutic strategies, the investigators are proposing to test the effectiveness of different formulations of medical cannabis oil to alleviate chronic pain, which was partially relieved with conventional prescriptions. Furthermore, the investigators would like to assess the effect of different formulations of medical cannabis oil on other symptoms associated to chronic pain like anxiety and depression, as well as insomnia and appetite. Finally, as recently recommended for clinical studies on medical cannabis, the investigators will examine the safety profile of different cannabis formulations focusing on the following elements: a real chronic administration with more than two weeks of treatment, a larger number of patients, and the clinical relevance of medical cannabis oil to change the amount and type of concomitant medications used to control chronic non-cancer and cancer pain.

Conditions

Interventions

DRUG

THC and CDB in a 1 to 1 ratio

capsule containing cannabis oil

DRUG

Experimental: THC and CBD in a 1 to 2 ratio

capsule containing cannabis oil

DRUG

High CBD with trace THC oil

capsule containing cannabis oil

OTHER

placebo

carrier oil capsule

Sponsors & Collaborators

  • Tetra Bio-Pharma

    collaborator INDUSTRY

  • Santé Cannabis

    lead OTHER

Principal Investigators

  • Antonio Vigano, MD, MSc · McGill University

  • Maria Fernanda Arboleda, MD · McGill University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-29
Primary Completion
2019-02-15
Completion
2019-02-15

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03337503 on ClinicalTrials.gov