Medical Cannabis for Treating Pain Related to Fibromyalgia

NCT ID: NCT05939466

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-09-30

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.

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

Other Intervention Names

Medical Cannabis

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Carlo Public Hospital, Potenza, Italy

OTHER

Sponsor Role: collaborator

Universita degli Studi della Basilicata

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Giardina

Role: STUDY_DIRECTOR

San Carlo Hospital, Potenza, Italy

Rocco Palmieri

Role: PRINCIPAL_INVESTIGATOR

San Carlo Hospital, Potenza, Italy

Locations

Pain Therapy Unit, San Carlo Hospital

Potenza, , Italy

Countries

Italy

Other Identifiers

PzAOR San Carlo - Bedrocan®

Identifier Type: -

Identifier Source: org_study_id