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Clinical Trials/ACTRN12622000723785
ACTRN12622000723785
Not yet recruiting
Phase 2

Phase IIa randomized, placebo-controlled, double-blind crossover pilot study of tolerability and efficacy of cannabidiol (CBD) and palmitoylethanolamide (PEA) applied to the skin for the relief of osteoarthritic joint pain.

Westmead Hospital0 sites72 target enrollmentMay 20, 2022
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Westmead Hospital
Enrollment
72
Status
Not yet recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 20, 2022
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Westmead Hospital

Eligibility Criteria

Inclusion Criteria

  • •1\. Diagnosis of OA defined by X\-ray evidence of joint damage;
  • •2\. Age 30–90;
  • •3\. Disease duration of 2 years or more;
  • •4\. Continued pain in any of the knee, hip, hands or lower lumbar spine joints despite oral
  • •medications;
  • •5\. No previous use of oral or smoked cannabinoids for pain management; able to complete
  • •questionnaire;
  • •6\. Able to attend outpatient clinic at monitoring and follow\-up time points.

Exclusion Criteria

  • •1\. History of psychiatric disorder;
  • •2\. History of drug dependency;
  • •3\. Known sensitivity to cannabinoid agents;
  • •4\. History of epilepsy; patient pain explained by fibromyalgia;
  • •5\. Recurrent or recent malignancy;
  • •6\. Pregnancy or breastfeeding;
  • •7\. Change of pain medication in the preceding 4 weeks;
  • •8\. Severe renal or liver dysfunction (patient excluded if there is an elevation of baseline liver enzymes);
  • •9\. Concomitant medications: Prior or current cannabis use; current use of valproate, clobazam, topiramate, and/or rufinamide.

Outcomes

Primary Outcomes

Not specified

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