Efficacy and safety of cannabidiol followed by an open label add-on of tetrahydrocannabinol for the treatment of chronic pain in patients with rheumatoid arthritis or ankylosing spondylitis

Protocol for a multicentre, randomised, placebo-controlled study

Oliver Hendricks*, Tonny Elmose Andersen, Afshin Ashouri Christiansen, Jette Primdahl, Ellen Margrethe Hauge, Torkell Ellingsen, Tina Ingrid Horsted, Anja Godske Bachmann, Anne Gitte Loft, Anders Bo Bojesen, Mikkel Østergaard, Merete Lund Hetland, Niels Steen Krogh, Kirsten Kaya Roessler, Kim Hørslev Petersen

*Kontaktforfatter for dette arbejde

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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Resumé

Introduction Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) are chronic, systemic, inflammatory diseases, primarily in the musculoskeletal system. Pain and fatigue are key symptoms of RA and AS. Treatment presents a clinical challenge for several reasons, including the progressive nature of the diseases and the involvement of multiple pain mechanisms. Moreover, side effects of pain treatment pose an implicit risk. Currently, no well-controlled studies have investigated how medical cannabis affects pain and cognitive functions in RA and AS. The present study aims to evaluate the efficacy and safety of medical cannabis in the treatment of persistent pain in patients with RA and AS with low disease activity. Methods and analysis A double-blinded, randomised, placebo-controlled study of cannabidiol (CBD), followed by an open label add-on of tetrahydrocannabinol (THC) with collection of clinical data and biological materials in RA and AS patients treated in routine care. The oral treatment with CBD in the experimental group is compared with placebo in a control group for 12 weeks, followed by an observational 12-week period with an open label add-on of THC in the primary CBD non-responders. Disease characteristics, psychological parameters, demographics, comorbidities, lifestyle factors, blood samples and serious adverse events are collected at baseline, after 12 and 24 weeks of treatment, and at a follow-up visit at 36 weeks. Data will be analysed in accordance with a predefined statistical analysis plan. Ethics and dissemination The Danish Ethics Committee (S-20170217), the Danish Medicines Agency (S-2018010018) and the Danish Data Protection Agency approved the protocol. The project is registered in the European Clinical Trials Database (EudraCT 2017-004226-15). All participants will give written informed consent to participate prior to any study-related procedures. The results will be presented at international conferences and published in peer-reviewed journals.

OriginalsprogEngelsk
Artikelnummere028197
TidsskriftBMJ Open
Vol/bind9
Udgave nummer6
Antal sider9
ISSN2044-6055
DOI
StatusUdgivet - 4. jun. 2019

Fingeraftryk

Chronic Pain
Placebos
Safety
Medical Marijuana
Computer Security
Musculoskeletal System
Ethics Committees
Informed Consent
Ethics
Cognition
Comorbidity
Clinical Trials
Databases
Control Groups

Citer dette

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title = "Efficacy and safety of cannabidiol followed by an open label add-on of tetrahydrocannabinol for the treatment of chronic pain in patients with rheumatoid arthritis or ankylosing spondylitis: Protocol for a multicentre, randomised, placebo-controlled study",
abstract = "Introduction Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) are chronic, systemic, inflammatory diseases, primarily in the musculoskeletal system. Pain and fatigue are key symptoms of RA and AS. Treatment presents a clinical challenge for several reasons, including the progressive nature of the diseases and the involvement of multiple pain mechanisms. Moreover, side effects of pain treatment pose an implicit risk. Currently, no well-controlled studies have investigated how medical cannabis affects pain and cognitive functions in RA and AS. The present study aims to evaluate the efficacy and safety of medical cannabis in the treatment of persistent pain in patients with RA and AS with low disease activity. Methods and analysis A double-blinded, randomised, placebo-controlled study of cannabidiol (CBD), followed by an open label add-on of tetrahydrocannabinol (THC) with collection of clinical data and biological materials in RA and AS patients treated in routine care. The oral treatment with CBD in the experimental group is compared with placebo in a control group for 12 weeks, followed by an observational 12-week period with an open label add-on of THC in the primary CBD non-responders. Disease characteristics, psychological parameters, demographics, comorbidities, lifestyle factors, blood samples and serious adverse events are collected at baseline, after 12 and 24 weeks of treatment, and at a follow-up visit at 36 weeks. Data will be analysed in accordance with a predefined statistical analysis plan. Ethics and dissemination The Danish Ethics Committee (S-20170217), the Danish Medicines Agency (S-2018010018) and the Danish Data Protection Agency approved the protocol. The project is registered in the European Clinical Trials Database (EudraCT 2017-004226-15). All participants will give written informed consent to participate prior to any study-related procedures. The results will be presented at international conferences and published in peer-reviewed journals.",
keywords = "ankylosing spondylitis, chronic pain, rheumatoid arthritis, treatment with medical cannabis",
author = "Oliver Hendricks and Andersen, {Tonny Elmose} and Christiansen, {Afshin Ashouri} and Jette Primdahl and Hauge, {Ellen Margrethe} and Torkell Ellingsen and Horsted, {Tina Ingrid} and Bachmann, {Anja Godske} and Loft, {Anne Gitte} and Bojesen, {Anders Bo} and Mikkel {\O}stergaard and {Lund Hetland}, Merete and Krogh, {Niels Steen} and Roessler, {Kirsten Kaya} and Petersen, {Kim H{\o}rslev}",
year = "2019",
month = "6",
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doi = "10.1136/bmjopen-2018-028197",
language = "English",
volume = "9",
journal = "B M J Open",
issn = "2044-6055",
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}

Efficacy and safety of cannabidiol followed by an open label add-on of tetrahydrocannabinol for the treatment of chronic pain in patients with rheumatoid arthritis or ankylosing spondylitis : Protocol for a multicentre, randomised, placebo-controlled study. / Hendricks, Oliver; Andersen, Tonny Elmose; Christiansen, Afshin Ashouri; Primdahl, Jette; Hauge, Ellen Margrethe; Ellingsen, Torkell; Horsted, Tina Ingrid; Bachmann, Anja Godske; Loft, Anne Gitte; Bojesen, Anders Bo; Østergaard, Mikkel; Lund Hetland, Merete; Krogh, Niels Steen; Roessler, Kirsten Kaya; Petersen, Kim Hørslev.

I: BMJ Open, Bind 9, Nr. 6, e028197, 04.06.2019.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Efficacy and safety of cannabidiol followed by an open label add-on of tetrahydrocannabinol for the treatment of chronic pain in patients with rheumatoid arthritis or ankylosing spondylitis

T2 - Protocol for a multicentre, randomised, placebo-controlled study

AU - Hendricks, Oliver

AU - Andersen, Tonny Elmose

AU - Christiansen, Afshin Ashouri

AU - Primdahl, Jette

AU - Hauge, Ellen Margrethe

AU - Ellingsen, Torkell

AU - Horsted, Tina Ingrid

AU - Bachmann, Anja Godske

AU - Loft, Anne Gitte

AU - Bojesen, Anders Bo

AU - Østergaard, Mikkel

AU - Lund Hetland, Merete

AU - Krogh, Niels Steen

AU - Roessler, Kirsten Kaya

AU - Petersen, Kim Hørslev

PY - 2019/6/4

Y1 - 2019/6/4

N2 - Introduction Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) are chronic, systemic, inflammatory diseases, primarily in the musculoskeletal system. Pain and fatigue are key symptoms of RA and AS. Treatment presents a clinical challenge for several reasons, including the progressive nature of the diseases and the involvement of multiple pain mechanisms. Moreover, side effects of pain treatment pose an implicit risk. Currently, no well-controlled studies have investigated how medical cannabis affects pain and cognitive functions in RA and AS. The present study aims to evaluate the efficacy and safety of medical cannabis in the treatment of persistent pain in patients with RA and AS with low disease activity. Methods and analysis A double-blinded, randomised, placebo-controlled study of cannabidiol (CBD), followed by an open label add-on of tetrahydrocannabinol (THC) with collection of clinical data and biological materials in RA and AS patients treated in routine care. The oral treatment with CBD in the experimental group is compared with placebo in a control group for 12 weeks, followed by an observational 12-week period with an open label add-on of THC in the primary CBD non-responders. Disease characteristics, psychological parameters, demographics, comorbidities, lifestyle factors, blood samples and serious adverse events are collected at baseline, after 12 and 24 weeks of treatment, and at a follow-up visit at 36 weeks. Data will be analysed in accordance with a predefined statistical analysis plan. Ethics and dissemination The Danish Ethics Committee (S-20170217), the Danish Medicines Agency (S-2018010018) and the Danish Data Protection Agency approved the protocol. The project is registered in the European Clinical Trials Database (EudraCT 2017-004226-15). All participants will give written informed consent to participate prior to any study-related procedures. The results will be presented at international conferences and published in peer-reviewed journals.

AB - Introduction Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) are chronic, systemic, inflammatory diseases, primarily in the musculoskeletal system. Pain and fatigue are key symptoms of RA and AS. Treatment presents a clinical challenge for several reasons, including the progressive nature of the diseases and the involvement of multiple pain mechanisms. Moreover, side effects of pain treatment pose an implicit risk. Currently, no well-controlled studies have investigated how medical cannabis affects pain and cognitive functions in RA and AS. The present study aims to evaluate the efficacy and safety of medical cannabis in the treatment of persistent pain in patients with RA and AS with low disease activity. Methods and analysis A double-blinded, randomised, placebo-controlled study of cannabidiol (CBD), followed by an open label add-on of tetrahydrocannabinol (THC) with collection of clinical data and biological materials in RA and AS patients treated in routine care. The oral treatment with CBD in the experimental group is compared with placebo in a control group for 12 weeks, followed by an observational 12-week period with an open label add-on of THC in the primary CBD non-responders. Disease characteristics, psychological parameters, demographics, comorbidities, lifestyle factors, blood samples and serious adverse events are collected at baseline, after 12 and 24 weeks of treatment, and at a follow-up visit at 36 weeks. Data will be analysed in accordance with a predefined statistical analysis plan. Ethics and dissemination The Danish Ethics Committee (S-20170217), the Danish Medicines Agency (S-2018010018) and the Danish Data Protection Agency approved the protocol. The project is registered in the European Clinical Trials Database (EudraCT 2017-004226-15). All participants will give written informed consent to participate prior to any study-related procedures. The results will be presented at international conferences and published in peer-reviewed journals.

KW - ankylosing spondylitis

KW - chronic pain

KW - rheumatoid arthritis

KW - treatment with medical cannabis

U2 - 10.1136/bmjopen-2018-028197

DO - 10.1136/bmjopen-2018-028197

M3 - Journal article

VL - 9

JO - B M J Open

JF - B M J Open

SN - 2044-6055

IS - 6

M1 - e028197

ER -