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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05939466
Recruitment Status : Completed
First Posted : July 11, 2023
Last Update Posted : July 11, 2023
Sponsor:
Collaborator:
San Carlo Public Hospital, Potenza, Italy
Information provided by (Responsible Party):
Universita degli Studi della Basilicata

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Bedrocan®-type cannabis (22% THC, <1% CBD) Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Is Low Dosage of Medical Cannabis Effective for Treating Pain Related to Fibromyalgia?
Actual Study Start Date : March 1, 2021
Actual Primary Completion Date : September 1, 2021
Actual Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Medical Cannabis


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05939466


Locations
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Italy
Pain Therapy Unit, San Carlo Hospital
Potenza, Italy, 85100
Sponsors and Collaborators
Universita degli Studi della Basilicata
San Carlo Public Hospital, Potenza, Italy
Investigators
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Study Director: Antonio Giardina San Carlo Hospital, Potenza, Italy
Principal Investigator: Rocco Palmieri San Carlo Hospital, Potenza, Italy
More Information
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Responsible Party: Universita degli Studi della Basilicata
ClinicalTrials.gov Identifier: NCT05939466    
Other Study ID Numbers: PzAOR San Carlo - Bedrocan®
First Posted: July 11, 2023    Key Record Dates
Last Update Posted: July 11, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Universita degli Studi della Basilicata:
Fibromyalgia
Medical cannabis
Bedrocan®
Pain
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases