FibromyalgiaPhase 4Bedrocan®-LDNCT05939466
Medical Cannabis for Treating Pain Related to Fibromyalgia
A Phase 4 study testing Bedrocan®-type cannabis (22% THC, <1% CBD) in people with Fibromyalgia, run by Universita degli Studi della Basilicata at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Bedrocan®-type cannabis (22% THC, <1% CBD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2021to 30 Sep 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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®).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Bedrocan®-type cannabis (22% THC, <1% CBD)
- Keywords
- Fibromyalgia, Medical cannabis, Bedrocan®, Pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedrocan®-type cannabis (22% THC, <1% CBD)Drug
Also called Medical Cannabis
Decoction with 100 mg of Bedrocan®-type cannabis (22% THC, <1% CBD)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bedrocan®-type cannabis (22% THC, <1% CBD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Mar 2021
- Primary completion1 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita degli Studi della Basilicata
- Sponsor type
- University, hospital or other
- Collaborators
- San Carlo Public Hospital, Potenza, Italy
- Responsible party
- Sponsor
- Investigators
- Antonio Giardina, Study director, San Carlo Hospital, Potenza, ItalyRocco Palmieri, Principal investigator, San Carlo Hospital, Potenza, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939466
- Sponsor's protocol ID
- PzAOR San Carlo - Bedrocan®
- Acronym
- Bedrocan®-LD
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Low Dosage of Medical Cannabis Effective for Treating Pain Related to Fibromyalgia?
- ClinicalTrials.gov ID
- NCT05939466
- Acronym / sponsor ID
- Bedrocan®-LD / PzAOR San Carlo - Bedrocan®
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Medical cannabis, Bedrocan®, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universita degli Studi della BasilicataUniversity, hospital or other
- Collaborators
- San Carlo Public Hospital, Potenza, Italy
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FM patients treated with Bedrocan® | Experimental | Drug: Bedrocan®-type cannabis (22% THC, <1% CBD)Medical cannabis was administered by herbal tea or decoction as described by the Ministry of Health through the Ministerial Decree of 9 November 2015. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedrocan®-type cannabis (22% THC, <1% CBD)Also: Medical CannabisDecoction with 100 mg of Bedrocan®-type cannabis (22% THC, <1% CBD) | Drug | FM patients treated with Bedrocan® |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Giardina study director
San Carlo Hospital, Potenza, Italy
Rocco Palmieri principal investigator
San Carlo Hospital, Potenza, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bedrocan®-type cannabis (22% THC, <1% CBD) in people with Fibromyalgia, run by Universita degli Studi della Basilicata at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.