NCT05939466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
Last Updated

July 11, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

June 22, 2023

Last Update Submit

June 30, 2023

Conditions

Fibromyalgia

Keywords

FibromyalgiaMedical cannabisBedrocan®Pain

Outcome Measures

Primary Outcomes (3)

  • Pain intensity

    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

    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

    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

Study Arms (1)

FM patients treated with Bedrocan®

EXPERIMENTAL

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)

Interventions

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

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

Also known as: Medical Cannabis
FM patients treated with Bedrocan®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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®).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Therapy Unit, San Carlo Hospital

Potenza, 85100, Italy

Location

MeSH Terms

Conditions

FibromyalgiaPain

Interventions

DronabinolMedical Marijuana

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic ChemicalsPharmaceutical Preparations

Study Officials

  • Antonio Giardina

    San Carlo Hospital, Potenza, Italy

    STUDY DIRECTOR

  • Rocco Palmieri

    San Carlo Hospital, Potenza, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2023

First Posted

July 11, 2023

Study Start

March 1, 2021

Primary Completion

September 1, 2021

Study Completion

September 30, 2021

Last Updated

July 11, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)