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Cannabinoid

THC and CDB in a 1 to 1 ratio for Chronic Pain

Phase 4
Waitlist Available
Led By Antonio Vigano, MD, MSc
Research Sponsored by Santé Cannabis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline in nrs at weeks 1 and 6 and in follow-up phase at weeks 10 and 18.
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline in nrs at weeks 1 and 6 and in follow-up phase at weeks 10 and 18.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline in nrs at weeks 1 and 6 and in follow-up phase at weeks 10 and 18. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Does the daily use of cannabis oil improves chronic pain
Secondary outcome measures
Does the daily use of cannabis oil improve Medication Quantification Scale (MQS) version III
Does the daily use of cannabis oil improve cognition
Does the daily use of cannabis oil improve symptom burden
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: high CBD with trace THCExperimental Treatment1 Intervention
Post a self-titrating schedule of medical cannabis oil, subjects take 1 capsule three times a day at 6 hour intervals. 20 mg CBD with traces of THC
Group II: THC and CDB in a 1 to 1 ratioExperimental Treatment1 Intervention
Post a self-titrating schedule of medical cannabis oil, subjects take 1 capsule three times a day at 6 hour intervals. 2.5 mg THC with 2.5 mg CBD capsule
Group III: THC and CBD in a 1 to 2 ratioExperimental Treatment1 Intervention
Post a self-titrating schedule of medical cannabis oil, subjects take 1 capsule three times a day at 6 hour intervals. 2.5 mg THC with 5 mg CBD capsule
Group IV: placeboPlacebo Group1 Intervention
Post a self-titrating schedule of carrier oil, subjects take 1 capsule three times a day at 6 hour intervals. carrier oil capsule

Find a Location

Who is running the clinical trial?

Tetra Bio-PharmaIndustry Sponsor
7 Previous Clinical Trials
600 Total Patients Enrolled
1 Trials studying Chronic Pain
8 Patients Enrolled for Chronic Pain
Santé CannabisLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Antonio Vigano, MD, MScPrincipal InvestigatorMcGill University
2 Previous Clinical Trials
68 Total Patients Enrolled
1 Trials studying Chronic Pain
8 Patients Enrolled for Chronic Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
Santé Cannabis
What portion of applicants met pre-screening criteria?
Met criteria
~22 spots leftby May 2025