Clinical trial NCT05939466: Medical Cannabis for Treating Pain Related to Fibromyalgia
Official title: Is Low Dosage of Medical Cannabis Effective for Treating Pain Related to Fibromyalgia?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Medical cannabis
Bedrocan®
Pain
Lead sponsor: Universita degli Studi della Basilicata
Sponsor class: OTHER
Collaborators: name: San Carlo Public Hospital, Potenza, Italy
First posted: 2023-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain intensity
timeFrame: 6 months
measure: Physical state
timeFrame: 6 months
measure: Mental state
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Potenza
country: Italy
facility: Pain Therapy Unit, San Carlo Hospital
Study officials:
affiliation: San Carlo Hospital, Potenza, Italy
name: Antonio Giardina
role: STUDY_DIRECTOR
affiliation: San Carlo Hospital, Potenza, Italy
name: Rocco Palmieri
role: PRINCIPAL_INVESTIGATOR
References: