NCT03337503

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

Terminated Phase 2 Last updated 2 December 2024

What this trial tests

Phase 2 trial testing THC and CDB in a 1 to 1 ratio in Chronic Pain in 161 participants. Terminated before completion.

Timeline

29 January 2018

Primary endpoint
15 February 2019

15 February 2019

Quick facts

Lead sponsor	Santé Cannabis
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	161
Start date	29 January 2018
Primary completion	15 February 2019
Estimated completion	15 February 2019
Sites	1 location across Canada

Drugs / interventions tested

• THC and CDB in a 1 to 1 ratio — full drug profile →
• Experimental: THC and CBD in a 1 to 2 ratio — full drug profile →
• High CBD with trace THC oil — full drug profile →
• placebo

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →

Sponsor

Santé Cannabis — full company profile →

Who can join

18 and older, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Use of Psychedelics in the Treatment of Medical Conditions: An Analysis of Currently Registered Psychedelics Studies in the American Drug Trial Registry.
   Kurtz JS, Patel NA, Gendreau JL, Yang C, et al · · 2022 · cited 19× · PMID 36259015 · DOI 10.7759/cureus.29167
2. Applications of Cannabinoids in Neuropathic Pain: An Updated Review.
   Arthur P, Kalvala AK, Surapaneni SK, Singh MS. · · 2024 · cited 12× · PMID 37824417 · DOI 10.1615/critrevtherdrugcarriersyst.2022038592