Medical Cannabis for Treating Pain Related to Fibromyalgia (Bedrocan®-LD)

June 30, 2023 updated by: Universita degli Studi della Basilicata

Is Low Dosage of Medical Cannabis Effective for Treating Pain Related to Fibromyalgia?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study took place in the pain therapy unit of San Carlo Hospital (Potenza, Italy) between March 2021 and September 2021. Over this period, 44 subjects visited the pain unit and underwent specialist evaluation. Fibromyalgia syndrome was confirmed using the Widespread Pain Index (WPI) and Symptom Severity (SS) scale criteria, resulting in the recruitment of 34 subjects. Two participants discontinued therapy due to side effects, while 2 other patients were excluded for not initiating treatment within the required timeframe. Therefore, the final number of recruited fibromyalgic subjects for the study was 30. Among these subjects, those who provided informed written consent for starting the trial with medical cannabis were prescribed Bedrocan® once a month, with a total of 30 prescriptions per month for a duration of 6 months.

All patients were instructed on how to prepare the decoction; the therapy was started with 100 mg/day (1 chart) and increased to 200 mg/day (2 charts) in non-responsive subjects.

The Numerical Rating Scale (NRS) and SF-12 Short Form health questionnaire were used to evaluate pain intensity and the quality of life at the beginning of the study and 6th-month follow-up.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Potenza, Italy, 85100
        • Pain Therapy Unit, San Carlo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Informed written consent;
  • Age >18 years old;
  • Diagnosis of FM confirmed by a rheumatologist;
  • Persistent pain symptoms for at least three months without complaints that may otherwise explain the pain condition;
  • Persistent pain syndrome on conventional therapy with opioids or non-steroidal anti- inflammatory drugs
  • Not having taken medical cannabis in the previous year since the start of the study
  • Stopping drug therapy during the trial with cannabis (Bedrocan®).

Exclusion Criteria:

  • Specific contraindications to cannabinoid use;
  • Pain syndrome not associated with FM
  • Major comorbidities like renal impairment, severe liver disease, chronic hepatitis C, history of alcohol or drug addiction
  • The presence of cognitive deficits that could impair understanding of the study, completion of questionnaires, or adherence to therapy.
  • Pregnant or planning pregnancy women and breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FM patients treated with Bedrocan®
Medical cannabis was administered by herbal tea or decoction as described by the Ministry of Health through the Ministerial Decree of 9 November 2015.
Drug: Bedrocan®-type cannabis (22% THC, <1% CBD)
Decoction with 100 mg of Bedrocan®-type cannabis (22% THC, <1% CBD)
Other Names:
  • Medical Cannabis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 6 months
Pain intensity evaluated with the Numerical Rating Scale (NRS). NRS involves asking individuals to rate their pain on a numerical scale typically ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.
6 months
Physical state
Time Frame: 6 months
Physical state was evaluated with the Physical Component Summary of the Short-form health survey SF-12 questionnaire (PCS-12). The PCS-12 provides a summary score that reflects the individual's overall physical health status; it can range from 10.5 to 69.7, with higher scores indicating better physical functioning and well-being.
6 months
Mental state
Time Frame: 6 months
Mental state was evaluated with the Mental Component Summary of the SF-12 questionnaire (MCS-12). MCS-12 provides a summary score, ranging between 7.4 to 72.1, that reflects the individual's overall mental health status. Higher scores on the MCS-12 indicate better mental well-being, while lower scores may indicate higher levels of psychological distress or impairment in social and emotional functioning.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita degli Studi della Basilicata

Collaborators

San Carlo Public Hospital, Potenza, Italy

Investigators

  • Study Director: Antonio Giardina, San Carlo Hospital, Potenza, Italy
  • Principal Investigator: Rocco Palmieri, San Carlo Hospital, Potenza, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

June 30, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PzAOR San Carlo - Bedrocan®

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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