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Medical Cannabis for Treating Pain Related to Fibromyalgia

NCT05939466 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-07-11

No results posted yet for this study

Summary

The goal of this interventional study is to learn about the effect of Medicinal Cannabis (Bedrocan®) on Fibromyalgia patients with pain resistant to conventional therapy. The main question the trial aims to answer are:

* Is Bedrocan® effective for treating fibromyalgia-related pain in patients resistant to conventional therapy?
* Can a low dosage of medical cannabis taken as a decoction reduce fibromyalgic pain?

All patients were trained on how to make the decoction: therapy was started with 100 mg/day (1 folder) and increased to 200 mg/day (2 folders) in non-responders.

Conditions

  • Fibromyalgia

Interventions

DRUG

Bedrocan®-type cannabis (22% THC, <1% CBD)

Decoction with 100 mg of Bedrocan®-type cannabis (22% THC, \<1% CBD)

Sponsors & Collaborators

  • San Carlo Public Hospital, Potenza, Italy

    collaborator OTHER

  • Universita degli Studi della Basilicata

    lead OTHER

Principal Investigators

  • Antonio Giardina · San Carlo Hospital, Potenza, Italy

  • Rocco Palmieri · San Carlo Hospital, Potenza, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-09-01
Completion
2021-09-30

Countries

  • Italy

Study Locations

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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 NCT05939466 on ClinicalTrials.gov