Cannabis Extract in Fibromyalgia Syndrome - the SUNRISE Study

NCT06747039 | Recruiting

• 1 other identifier: SUNRISE (L4184)
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to evaluate the effects of cannabis extract Avextra 10/10 solution on pain, fatigue, sleep, and quality of life among patients affected by fibromyalgia (FM) syndrome. The main question it aims to answer is: 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.

Conditions

Fibromyalgia (FM)

Keywords

fibromyalgia; cannabis; pain; fatigue; quality of life; sleep disturbances

Outcome Measures

Primary Outcomes (1)

• Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain after 12 weeks among patients affected by FM

  The primary endpoint is based on a comparative analysis between the Visual Analogic Scale (VAS) score reported before cannabis extract Avextra 10/10 solution and after 12 weeks of therapy. VAS will use a 100 mm pain line where 0 represents "no pain at all" and 100 is "maximum pain ever experienced".

  12 weeks

Secondary Outcomes (7)

• Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on sleep quality among patients affected by FM using Pittsburgh sleep quality index (PSQI)

  4, 8 and 12 weeks

• Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain using Widespread pain indexWPI

  4, 8 and 12 weeks

• Evaluate the effect of cannabis extract Avextra 10/10 solution on the quality of life using The Italian versions of the Revised Fibromyalgia Impact Questionnaire (FIQR)

  4, 8 and 12 weeks

• Describe any adverse events or the principal reasons of drug discontinuation.

  4,8,12 weeks

• 1. Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain after 12 weeks among patients affected by FM

  4, 8 weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients afferent to IRCCS Ospedale Galeazzi Sant- Ambrogio in Milan (Italy) with FIbromyalgia Syndrome who will start therapy with cannabis extract Avextra 10/10.

You may qualify if:

• Patients with a diagnosis of FM according to 2016 American College of Rheumatology 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.

You may not qualify if:

• 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
• Pregnancy or breastfeeding

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Milano, 20157, Italy

RECRUITING

Related Publications (19)

• Sarzi-Puttini P, Giorgi V, Marotto D, Atzeni F. Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat Rev Rheumatol. 2020 Nov;16(11):645-660. doi: 10.1038/s41584-020-00506-w. Epub 2020 Oct 6.

  PMID: 33024295 BACKGROUND

• Pozzi G, Frustaci A, Tedeschi D, Solaroli S, Grandinetti P, Di Nicola M, Janiri L. Coping strategies in a sample of anxiety patients: factorial analysis and associations with psychopathology. Brain Behav. 2015 Aug;5(8):e00351. doi: 10.1002/brb3.351. Epub 2015 Jun 24.

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• Curcio G, Tempesta D, Scarlata S, Marzano C, Moroni F, Rossini PM, Ferrara M, De Gennaro L. Validity of the Italian version of the Pittsburgh Sleep Quality Index (PSQI). Neurol Sci. 2013 Apr;34(4):511-9. doi: 10.1007/s10072-012-1085-y. Epub 2012 Apr 13.

  PMID: 22526760 BACKGROUND

• Cerea S, Todd J, Ghisi M, Mancin P, Swami V. Psychometric properties of an Italian translation of the Functionality Appreciation Scale (FAS). Body Image. 2021 Sep;38:210-218. doi: 10.1016/j.bodyim.2021.04.007. Epub 2021 May 4.

  PMID: 33962221 BACKGROUND

• 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.

  PMID: 23806265 BACKGROUND

• 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.

  PMID: 35876631 BACKGROUND

• Aster HC, Evdokimov D, Braun A, Uceyler N, Sommer C. Analgesic Medication in Fibromyalgia Patients: A Cross-Sectional Study. Pain Res Manag. 2022 Sep 22;2022:1217717. doi: 10.1155/2022/1217717. eCollection 2022.

  PMID: 36247103 BACKGROUND

• Chaves C, Bittencourt PCT, Pelegrini A. Ingestion of a THC-Rich Cannabis Oil in People with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Pain Med. 2020 Oct 1;21(10):2212-2218. doi: 10.1093/pm/pnaa303.

  PMID: 33118602 BACKGROUND

• Giorgi V, Bongiovanni S, Atzeni F, Marotto D, Salaffi F, Sarzi-Puttini P. Adding medical cannabis to standard analgesic treatment for fibromyalgia: a prospective observational study. Clin Exp Rheumatol. 2020 Jan-Feb;38 Suppl 123(1):53-59. Epub 2020 Feb 5.

  PMID: 32116208 BACKGROUND

• Mazza M. Medical cannabis for the treatment of fibromyalgia syndrome: a retrospective, open-label case series. J Cannabis Res. 2021 Feb 17;3(1):4. doi: 10.1186/s42238-021-00060-6.

  PMID: 33597032 BACKGROUND

• Kurlyandchik I, Tiralongo E, Schloss J. Safety and Efficacy of Medicinal Cannabis in the Treatment of Fibromyalgia: A Systematic Review. J Altern Complement Med. 2021 Mar;27(3):198-213. doi: 10.1089/acm.2020.0331. Epub 2020 Dec 8.

  PMID: 33337931 BACKGROUND

• Cameron EC, Hemingway SL. Cannabinoids for fibromyalgia pain: a critical review of recent studies (2015-2019). J Cannabis Res. 2020 May 29;2(1):19. doi: 10.1186/s42238-020-00024-2.

  PMID: 33526114 BACKGROUND

• Walitt B, Fitzcharles MA, Hassett AL, Katz RS, Hauser W, Wolfe F. The longitudinal outcome of fibromyalgia: a study of 1555 patients. J Rheumatol. 2011 Oct;38(10):2238-46. doi: 10.3899/jrheum.110026. Epub 2011 Jul 15.

  PMID: 21765102 BACKGROUND

• Giorgi V, Sirotti S, Romano ME, Marotto D, Ablin JN, Salaffi F, Sarzi-Puttini P. Fibromyalgia: one year in review 2022. Clin Exp Rheumatol. 2022 Jun;40(6):1065-1072. doi: 10.55563/clinexprheumatol/if9gk2. Epub 2022 Jun 22.

  PMID: 35748720 BACKGROUND

• Martinez JE, Guimaraes I. "Fibromyalgia - are there any new approaches?". Best Pract Res Clin Rheumatol. 2024 Mar;38(1):101933. doi: 10.1016/j.berh.2024.101933. Epub 2024 Feb 13.

  PMID: 38355316 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 2306288 BACKGROUND

• Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.

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• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

  PMID: 20461783 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Marijuana Abuse; Pain; Fatigue; Parasomnias

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders

Study Officials

• Piercarlo Sarzi Puttini, Medical Doctor

  IRCCS Ospedale Galeazzi Sant'Ambrogio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Greta Pellegrino, Medical Doctor

CONTACT

0283500010; greta.pellegrino@grupposandonato.it

Piercarlo Sarzi Puttini, Medical Doctor

CONTACT

0283500010; piercarlo.sarziputtini@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: December 5, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)