Cannabis Extract in Fibromyalgia Syndrome - the SUNRISE Study
NCT ID: NCT06747039
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
38 participants
OBSERVATIONAL
2024-12-05
2025-12-31
Brief Summary
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Does cannabis extract have a positive effect on pain after 12 weeks in these patients?
Participants diagnosed from FM will be evaluated and will fill survey about their pain, fatigue, sleep, anxiety, depression and quality of life at baseline, 4 weeks, 8 weeks and 12 weeks after the initiation of cannabis extract Avextra 10/10 solution.
Detailed Description
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Cannabis-based treatments have gained attention for FM symptom management. In Italy, therapeutic cannabis has been legal since 2013 and may be prescribed when conventional treatments fail or cause intolerable side effects. Its primary components, tetrahydrocannabinol (THC) and cannabidiol (CBD), interact with cannabinoid receptors to potentially provide pain relief, anti-inflammatory effects, and mood stabilization.
The study aims to evaluate the efficacy of the standardized cannabis extract Avextra 10/10 (10 mg/mL THC and 10 mg/mL CBD) for FM treatment.
Objectives Primary objective: -Assess the extract's impact on pain after 12 weeks.
Secondary objective:
* Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on fatigue, sleep, anxiety and depression after 4, 8 and 12 weeks among patients affected by FM
* Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain after 4 and 8 weeks among patients affected by FM.
* Evaluate the effect of cannabis extract Avextra 10/10 solution on the quality of life at 4, 8 and 12 weeks among patients affected by FM.
* Describe any adverse events or the principal reasons of drug discontinuation.
Design and Methods This is a monocentric observational prospective study in which patients with FM who undertake cannabis therapy with cannabis extract Avextra 10/10 solution will consecutively be recruited.
Population: The inclusion criteria are:
* Patients with a diagnosis of FM according to 2016 American College of Rheumatology Criteria \[2\].
* Patients with FM prescribed cannabis extract Avextra 10/10 solution after failure and/or intolerance of first- or second-line treatment.
* Aged 18 years and older.
* Able to fully understand and fill questionnaires.
* Able to provide informed consent, according to requirements of local IRB/ethics committee.
The exclusion criteria are:
* Known history of pain not due to FM.
* Patients who have not received stable therapy for pain, sleep disorders, or any psychiatric condition for at least 2 weeks.
* Patients who are taking other types of medical cannabis besides Avextra 10/10 solution.
* Concomitant diagnosis of other pathologies that could interfere with clinical judgment.
* Psychiatric diagnosis according to DSM-V-TR
All patients with FM will undergo a standard clinical assessment, at baseline and at the follow-up visits, as part of the routine clinical practice. After the baseline visit, corresponding to the appointment where medical cannabis is prescribed within two weeks before the undertake of cannabis extract, follow-up visits will be scheduled according to routine clinical practice as follow:
* 15 days after the undertake of cannabis extract (T15)
* 30 days after the undertake of cannabis extract (T30)
* 60 days after the undertake of cannabis extract (T60)
* 90 days after the undertake of cannabis extract (T90)
* 6 months after the undertake of cannabis extract. All patients with FM will undergo a standard clinical assessment, at baseline and at the follow-up visits, as part of the routine clinical practice.
Data collected from participants during clinical evaluations at baseline visit will include:
* Demographic data: age, gender, BMI, residence
* Educational qualification
* Occupational status
* Age at menopause (if applicable)
* Current medication
* Comorbidities
* Symptom duration
* Age at FM diagnosis
* Number of sure tender point
* Smoke status
* Physical activity
Data collected from participants during clinical evaluations at follow-up visit will include:
* Number of sure tender point
* Smoke status
* Physical activity
* Efficacy or side effects of cannabis extract
* Discontinuation of cannabis extract
Conclusion The study seeks to establish the feasibility and clinical effects of a standardized cannabis extract for FM, addressing a critical gap in treatment strategies. Further research is needed to validate its efficacy and optimize FM management.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with a diagnosis of FM after failure and/or intolerance of first- and second-line treatment
Patients with a diagnosis of FM according to 2016 American College of Rheumatology Criteria, aged 18 years and older, able to fully understand and fill questionnaires and to provide fully informed consent, who failed and/or were intolerant of first- or second-line treatment.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients with FM prescribed cannabis extract Avextra 10/10 solution after failure and/or intolerance of first- or second-line treatment.
* Aged 18 years and older.
* Able to fully understand and fill questionnaires.
* Able to provide informed consent, according to requirements of local IRB/ethics committee.
Exclusion Criteria
* Patients who have not received stable therapy for pain, sleep disorders, or any psychiatric condition for at least 2 weeks.
* Patients who are taking other types of medical cannabis besides Avextra 10/10 solution.
* Concomitant diagnosis of other pathologies that could interfere with clinical judgment.
* Psychiatric diagnosis according to DSM-V-TR
* Pregnancy or breastfeeding
18 Years
ALL
No
Sponsors
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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
OTHER
Responsible Party
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Principal Investigators
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Piercarlo Sarzi Puttini, Medical Doctor
Role: PRINCIPAL_INVESTIGATOR
IRCCS Ospedale Galeazzi Sant'Ambrogio
Locations
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IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Milano, Italy
Countries
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Central Contacts
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References
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Salaffi F, Franchignoni F, Giordano A, Ciapetti A, Sarzi-Puttini P, Ottonello M. Psychometric characteristics of the Italian version of the revised Fibromyalgia Impact Questionnaire using classical test theory and Rasch analysis. Clin Exp Rheumatol. 2013 Nov-Dec;31(6 Suppl 79):S41-9. Epub 2013 Jun 26.
Sotoodeh R, Waldman LE, Vigano A, Moride Y, Canac-Marquis M, Spilak T, Gamaoun R, Kalaba M, Hachem Y, Beaulieu P, Desroches J, Ware MA, Perez J, Shir Y, Fitzcharles MA, Martel MO. Predictors of Pain Reduction Among Fibromyalgia Patients Using Medical Cannabis: A Long-Term Prospective Cohort Study. Arthritis Care Res (Hoboken). 2023 Jul;75(7):1588-1594. doi: 10.1002/acr.24985. Epub 2023 Feb 3.
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Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
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Other Identifiers
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SUNRISE (L4184)
Identifier Type: -
Identifier Source: org_study_id