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Article ; Online: Cannabis-opioid interaction in the treatment of fibromyalgia pain

Cornelis Jan van Dam / Monique van Velzen / Cornelis Kramers / Arnt Schellekens / Erik Olofsen / Marieke Niesters / Albert Dahan

Trials, Vol 24, Iss 1, Pp 1-

an open-label, proof of concept study with randomization between treatment groups: cannabis, oxycodone or cannabis/oxycodone combination—the SPIRAL study

2023 Volume 11

Abstract: Abstract Background Opioids continue to be widely prescribed for chronic noncancer pain, despite the awareness that opioids provide only short-time pain relief, lead to dose accumulation, have numerous adverse effects, and are difficult to wean. As an ... ...

Abstract	Abstract Background Opioids continue to be widely prescribed for chronic noncancer pain, despite the awareness that opioids provide only short-time pain relief, lead to dose accumulation, have numerous adverse effects, and are difficult to wean. As an alternative, we previously showed advantages of using pharmaceutical-grade cannabis in a population of chronic pain patients with fibromyalgia. It remains unknown whether combining an opioid with pharmaceutical-grade cannabis has advantages, such as fewer side effects from lesser opioid consumption in chronic pain. Methods Trial design: a single-center, randomized, three-arm, open-label, exploratory trial. Trial population: 60 patients with fibromyalgia according to the 2010 definition of the American College of Rheumatologists. Intervention: Patients will be randomized to receive up to 4 daily 5 mg oral oxycodone sustained release (SR) tablet, up to 5 times 150 mg inhaled cannabis (Bediol®, containing 6.3% Δ9-tetrahydrocannabinol and 8% cannabidiol), or the combination of both treatments. Treatment is aimed at self-titration with the daily maximum doses given. Treatment will continue for 6 weeks, after which there is a 6-week follow-up period. Main trial endpoint: The number of side effects observed during the course of treatment using a composite adverse effect score that includes the following 10 symptoms: dizziness (when getting up), sleepiness, insomnia, headache, nausea, vomiting, constipation, drug high, hallucinations, and paranoia. Secondary and tertiary endpoints include pain relief and number of oxycodone doses and cannabis inhalations. Discussion The trial is designed to determine whether self-titration of oxycodone and cannabis will reduce side effects in chronic pain patients with fibromyalgia. Trial registration {2a and 2b} EU trial register 2019–001861-33, URL https://www.clinicaltrialsregister.eu , on July 17, 2019; World Health Organization International Clinical Trials Research Platform NL7902, URL https://trialsearch.who.int , on July 26, 2019.
Keywords	Chronic pain ; Fibromyalgia ; Opioids ; Cannabis ; Adverse effects ; Pain relief ; Medicine (General) ; R5-920
Subject code	616
Language	English
Publishing date	2023-01-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Buprenorphine/naloxone versus methadone opioid rotation in patients with prescription opioid use disorder and chronic pain

Hannah Ellerbroek / Sandra A. S. van den Heuvel / Albert Dahan / Hans Timmerman / Cornelis Kramers / Arnt F. A. Schellekens

Addiction Science & Clinical Practice, Vol 17, Iss 1, Pp 1-

study protocol for a randomized controlled trial

2022 Volume 11

Abstract: Abstract Background Opioids are effective in pain-management, but long-term opioid users can develop prescription opioid use disorder (OUD). One treatment strategy in patients with OUD is rotating from a short-acting opioid to a long-acting opioid ( ... ...

Abstract	Abstract Background Opioids are effective in pain-management, but long-term opioid users can develop prescription opioid use disorder (OUD). One treatment strategy in patients with OUD is rotating from a short-acting opioid to a long-acting opioid (buprenorphine/naloxone (BuNa) or methadone). Both BuNa and methadone have been shown to be effective strategies in patients with OUD reducing opioid misuse, however data on head-to-head comparison in patients with chronic non-malignant pain and prescription OUD are limited. Methods This two-armed open-label, randomized controlled trial aims to compare effectiveness between BuNa and methadone in patients with chronic non-malignant with prescription OUD (n = 100). Participants receive inpatient rotation to either BuNa or methadone with a flexible dosing regimen. The primary outcome is opioid misuse 2 months after rotation. Secondary outcomes include treatment compliance, side effects, analgesia, opioid craving, quality of life, mood symptoms, cognitive and physical functioning over 2- and 6 months follow-up. Linear mixed model analysis will be used to evaluate change in outcome parameters over time between the treatment arms. Discussion This is one of the first studies comparing buprenorphine/naloxone and methadone for treating prescription OUD in a broad patient group with chronic non-malignant pain. Results may guide future treatment for patients with chronic pain and prescription OUD. Trial registration https://www.trialregister.nl/ , NL9781
Keywords	Opioid use disorder ; Methadone ; Buprenorphine/naloxone ; Chronic pain ; Current opioid misuse measure ; Medicine (General) ; R5-920 ; Social pathology. Social and public welfare. Criminology ; HV1-9960
Subject code	616
Language	English
Publishing date	2022-09-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Tackling rising numbers of opioid prescriptions users

Gerard Arnoldus Kalkman / Cornelis Kramers / Robert T van Dongen / Wim van den Brink / Arnt Schellekens

The Lancet Public Health, Vol 5, Iss 3, Pp e139- (2020)

2020

Keywords	Public aspects of medicine ; RA1-1270
Language	English
Publishing date	2020-03-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Discontinuation of antidepressant medication in primary care supported by monitoring plus mindfulness-based cognitive therapy versus monitoring alone

Carolien Wentink / Marloes J. Huijbers / Peter Lucassen / Cornelis Kramers / Reinier Akkermans / Eddy Adang / Jan Spijker / Anne E. M. Speckens

BMC Family Practice, Vol 20, Iss 1, Pp 1-

design and protocol of a cluster randomized controlled trial

2019 Volume 9

Abstract: Abstract Background Antidepressant use continues to rise, mainly explained by an increase in the proportion of patients receiving long term treatment. Although treatment guidelines recommend discontinuation after sustained remission, discontinuing ... ...

Abstract	Abstract Background Antidepressant use continues to rise, mainly explained by an increase in the proportion of patients receiving long term treatment. Although treatment guidelines recommend discontinuation after sustained remission, discontinuing antidepressants appears to be challenging for both patients and general practitioners (GPs). Mindfulness-Based Cognitive Therapy (MBCT) is an effective intervention that reduces the risk of relapse in recurrent depression and might facilitate discontinuation by teaching patients to cope with withdrawal symptoms and fear of relapse. The current study aims to investigate the effectiveness of the combination of Supported Protocolized Discontinuation (SPD) and MBCT in comparison with SPD alone in successful discontinuation of long-term use of antidepressants in primary care. Methods This study involves a cluster-randomized controlled trial conducted in primary care patients with long-term use antidepressants with baseline and 6, 9 and 12 months follow-up assessments. Patients choosing to discontinue their medication will be offered a combination of SPD and MBCT or SPD alone. Our primary outcome will be full discontinuation of antidepressant medication (= 0 mg) within 6 months after baseline assessment. Secondary outcome measures will be the severity of withdrawal symptoms, symptoms of depression and anxiety, psychological well-being, quality of life and medical and societal costs. Discussion In theory, stopping antidepressant medication seems straightforward. In practice however, patients and their GPs appear reluctant to initiate and accomplish this process. Both patients and professionals are in need of appropriate tools and information to better support the process of discontinuing antidepressant medication. Trial registration ClinicalTrials.gov PRS ID: NCT03361514 retrospectively registered October 2017.
Keywords	Antidepressants ; Discontinuation ; Tapering ; Long-term use ; General practitioner ; Primary health care ; Medicine (General) ; R5-920
Subject code	150
Language	English
Publishing date	2019-07-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: European List of Essential Medicines for Medical Education

Joao Costa / Ylva Böttiger / Fabrizio De Ponti / Thierry Christiaens / Sarah Garner / Cornelis Kramers / Erik Donker / David Brinkman / Milan Richir / Paraskevi Papaioannidou / Emilio J Sanz / Milo Gatti / Rahul Pandit / Michiel van Agtmael / Jelle Tichelaar

BMJ Open, Vol 11, Iss

a protocol for a modified Delphi study

2021 Volume 5

Abstract: Introduction Junior doctors are responsible for a substantial number of prescribing errors, and final-year medical students lack sufficient prescribing knowledge and skills just before they graduate. Various national and international projects have been ... ...

Abstract	Introduction Junior doctors are responsible for a substantial number of prescribing errors, and final-year medical students lack sufficient prescribing knowledge and skills just before they graduate. Various national and international projects have been initiated to reform the teaching of clinical pharmacology and therapeutics (CP&T) during undergraduate medical training. However, there is as yet no list of commonly prescribed and available medicines that European doctors should be able to independently prescribe safely and effectively without direct supervision. Such a list could form the basis for a European Prescribing Exam and would harmonise European CP&T education. Therefore, the aim of this study is to reach consensus on a list of widely prescribed medicines, available in most European countries, that European junior doctors should be able to independently prescribe safely and effectively without direct supervision: the European List of Essential Medicines for Medical Education.Methods and analysis This modified Delphi study will recruit European CP&T teachers (expert group). Two Delphi rounds will be carried out to enable a list to be drawn up of medicines that are available in ≥80% of European countries, which are considered standard prescribing practice, and which junior doctors should be able to prescribe safely and effectively without supervision.Ethics and dissemination The study has been approved by the Medical Ethics Review Committee of VU University Medical Center (no. 2020.335) and by the Ethical Review Board of the Netherlands Association for Medical Education (approved project no. NVMO‐ERB 2020.4.8). The European List of Essential Medicines for Medical Education will be presented at national and international conferences and will be submitted to international peer-reviewed journals. It will also be used to develop and implement the European Prescribing Exam.
Keywords	Medicine ; R
Subject code	028
Language	English
Publishing date	2021-06-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Trends in use and misuse of opioids in the Netherlands

Gerard Arnoldus Kalkman, Msc / Cornelis Kramers, ProfMD / Robert T van Dongen, PhD / Wim van den Brink, ProfMD / Arnt Schellekens, PhD

The Lancet Public Health, Vol 4, Iss 10, Pp e498-e

a retrospective, multi-source database study

2019 Volume 505

Abstract: Summary: Background: The USA is currently facing a serious opioid misuse epidemic that started with increased prescribing of oxycodone and the inclusion of pain as a fifth vital sign, and eventually resulted in massive overdose mortality. In Europe, ... ...

Abstract	Summary: Background: The USA is currently facing a serious opioid misuse epidemic that started with increased prescribing of oxycodone and the inclusion of pain as a fifth vital sign, and eventually resulted in massive overdose mortality. In Europe, including the Netherlands, the medical use of opioids (mainly oxycodone) has also increased since 2009, but an increase in proxies for opioid misuse has not yet been described. Methods: For this retrospective, multi-source database study, data were requested from several national databases in the Netherlands to evaluate the following time trends: (1) number of people with opioid prescriptions, (2) number of hospital admissions related to opioid intoxication, (3) number of people treated for opioid use disorder, and (4) number of people who died from opioid poisoning. Data were presented as the number per 100 000 inhabitants, using population data over the years 2008–17 from Statistics Netherlands (Centraal Bureau voor de Statistiek). Data about the number of people with opioid prescriptions was obtained from the Drug Information Project (Genees- en hulpmiddelen Informatie Project) database hosted by the Dutch National Health Care Institute (Zorginstituut Nederland). Data about opioid-related hospital admissions between 2008 and 2017 were obtained from the Dutch National Hospital Care Basic Registration (Landelijke Basisregistratie Ziekenhuiszorg), a database managed by Dutch Hospital Data. Data about addiction treatment were obtained from the National Alcohol and Drugs Information System (Landelijk Alcohol en Drugs Informatie Systeem). Data on opioid mortality between 2008 and 2017 were obtained from the cause-of-death statistics database hosted by Statistics Netherlands. Each database covered almost the entire population of the Netherlands. Findings: Between 2008 and 2017, the overall number of prescription opioid users nearly doubled from 4109 per 100 000 inhabitants to 7489 per 100 000 inhabitants, mainly because the number of oxycodone users quadrupled from 574 to 2568 per 100 000 inhabitants. In the same period, the number of opioid-related hospital admissions tripled from 2·5 to 7·8 per 100 000 inhabitants, and between 2008 and 2015 the number of patients in addiction care for opioid use disorders other than heroin increased from 3·1 to 5·6 per 100 000 inhabitants. Opioid-related mortality was stable between 2008 and 2014 with 0·21 deaths per 100 000 inhabitants, but after 2014 it increased to 0·65 per 100 000 inhabitants in 2017. Interpretation: Prescription opioid use increased substantially between 2008 and 2017, and several proxies for misuse show a parallel increasing trend. Although the Netherlands is far from the opioid epidemic faced by the USA, safe opioid prescribing guidelines should be implemented to prevent further escalation and to keep opioid painkillers available for those in need. Funding: Radboud University Nijmegen Medical Centre.
Keywords	Public aspects of medicine ; RA1-1270
Subject code	360
Language	English
Publishing date	2019-10-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The effects of substitution of hospital ward care from medical doctors to physician assistants on non-adherence to guidelines on medication prescribing.

Jacqueline M Bos / Marijke J C Timmermans / Gerard A Kalkman / Patricia M L A van den Bemt / Peter A G M De Smet / Michel Wensing / Cornelis Kramers / Miranda G H Laurant

PLoS ONE, Vol 13, Iss 8, p e

2018 Volume 0202626

Abstract: AIM:This study determined the effect of substitution of inpatient care from medical doctors (MDs) to physician assistants (PAs) on non-adherence to guidelines on medication prescribing. METHODS:A multicenter matched-controlled study was performed ... ...

Abstract	AIM:This study determined the effect of substitution of inpatient care from medical doctors (MDs) to physician assistants (PAs) on non-adherence to guidelines on medication prescribing. METHODS:A multicenter matched-controlled study was performed comparing wards on which PAs provide medical care in collaboration with MDs (PA/MD model), with wards on which only MDs provide medical care (MD model). A set of 17 quality indicators to measure non-adherence to guidelines on medication prescribing by PAs and MDs was composed by 14 experts in a modified Delphi procedure. The indicators covered different pharmacotherapeutic subjects, such as gastric protection in case of use of NSAID or prevention of obstipation in case of use of opioids. These indicators were expressed in proportions by dividing the number of patients in which the prescriber did not adhere to a guideline, by all patients that were applicable. Multivariable regression analysis was performed in order to adjust for potential confounders. RESULTS:1021 patients from 17 hospital wards in the 'PA/MD model' group and 1286 patients from 17 hospital wards in the 'MD model' group were included. Two of the 17 quality indicators showed significantly less non-adherence to guidelines for the PA/MD model; the indicators concerning prescribing gastric protection in case of use of NSAID in combination with corticosteroids (OR 0.42, 95% CI 0.19-0.90) and in case of use of NSAID in patients older than 70 years (OR 0.47, 95% 0.23-0.95). For none of the other quality indicators for prescribing of medication a difference between the MD model and the PA/MD model was found. CONCLUSION:This study suggests that the non-adherence to guidelines on medication prescribing on wards with the PA/MD model does not differ from wards with traditional house staffing by MDs only. Further research is needed to determine quality, efficiency and safety of prescribing behavior of PAs.
Keywords	Medicine ; R ; Science ; Q
Subject code	001
Language	English
Publishing date	2018-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Individualizing pharmacotherapy in patients with renal impairment

Willemijn L Eppenga / Cornelis Kramers / Hieronymus J Derijks / Michel Wensing / Jack F M Wetzels / Peter A G M De Smet

PLoS ONE, Vol 10, Iss 3, p e

the validity of the Modification of Diet in Renal Disease formula in specific patient populations with a glomerular filtration rate below 60 ml/min. A systematic review.

2015 Volume 0116403

Abstract: The Modification of Diet in Renal Disease (MDRD) formula is widely used in clinical practice to assess the correct drug dose. This formula is based on serum creatinine levels which might be influenced by chronic diseases itself or the effects of the ... ...

Abstract	The Modification of Diet in Renal Disease (MDRD) formula is widely used in clinical practice to assess the correct drug dose. This formula is based on serum creatinine levels which might be influenced by chronic diseases itself or the effects of the chronic diseases. We conducted a systematic review to determine the validity of the MDRD formula in specific patient populations with renal impairment: elderly, hospitalized and obese patients, patients with cardiovascular disease, cancer, chronic respiratory diseases, diabetes mellitus, liver cirrhosis and human immunodeficiency virus.We searched for articles in Pubmed published from January 1999 through January 2014. Selection criteria were (1) patients with a glomerular filtration rate (GFR) < 60 ml/min (/1.73 m2), (2) MDRD formula compared with a gold standard and (3) statistical analysis focused on bias, precision and/or accuracy. Data extraction was done by the first author and checked by a second author. A bias of 20% or less, a precision of 30% or less and an accuracy expressed as P30% of 80% or higher were indicators of the validity of the MDRD formula. In total we included 27 studies. The number of patients included ranged from 8 to 1831. The gold standard and measurement method used varied across the studies. For none of the specific patient populations the studies provided sufficient evidence of validity of the MDRD formula regarding the three parameters. For patients with diabetes mellitus and liver cirrhosis, hospitalized patients and elderly with moderate to severe renal impairment we concluded that the MDRD formula is not valid. Limitations of the review are the lack of considering the method of measuring serum creatinine levels and the type of gold standard used.In several specific patient populations with renal impairment the use of the MDRD formula is not valid or has uncertain validity.
Keywords	Medicine ; R ; Science ; Q
Subject code	616
Language	English
Publishing date	2015-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Prediction of clinically relevant adverse drug events in surgical patients.

Jacqueline M Bos / Gerard A Kalkman / Hans Groenewoud / Patricia M L A van den Bemt / Peter A G M De Smet / J Elsbeth Nagtegaal / Andre Wieringa / Gert Jan van der Wilt / Cornelis Kramers

PLoS ONE, Vol 13, Iss 8, p e

2018 Volume 0201645

Abstract: BACKGROUND:Risk stratification of hospital patients for adverse drug events would enable targeting patients who may benefit from interventions aimed at reducing drug-related morbidity. It would support clinicians and hospital pharmacists in selecting ... ...

Abstract	BACKGROUND:Risk stratification of hospital patients for adverse drug events would enable targeting patients who may benefit from interventions aimed at reducing drug-related morbidity. It would support clinicians and hospital pharmacists in selecting patients to deliver a more efficient health care service. This study aimed to develop a prediction model that helps to identify patients on the day of hospital admission who are at increased risk of developing a clinically relevant, preventable adverse drug event during their stay on a surgical ward. METHODS:Data of the pre-intervention measurement period of the P-REVIEW study were used. This study was designed to assess the impact of a multifaceted educational intervention on clinically relevant, preventable adverse drug events in surgical patients. Thirty-nine variables were evaluated in a univariate and multivariate logistic regression analysis, respectively. Model performance was expressed in the Area Under the Receiver Operating Characteristics. Bootstrapping was used for model validation. RESULTS:6780 admissions of patients at surgical wards were included during the pre-intervention period of the PREVIEW trial. 102 patients experienced a clinically relevant, adverse drug event during their hospital stay. The prediction model comprised five variables: age, number of biochemical tests ordered, heparin/LMWH in therapeutic dose, use of opioids, and use of cardiovascular drugs. The AUROC was 0.86 (95% CI 0.83-0.88). The model had a sensitivity of 80.4% and a specificity of 73.4%. The positive and negative predictive values were 4.5% and 99.6%, respectively. Bootstrapping generated parameters in the same boundaries. CONCLUSIONS:The combined use of a limited set of easily ascertainable patient characteristics can help physicians and pharmacists to identify, at the time of admission, surgical patients who are at increased risk of developing ADEs during their hospital stay. This may serve as a basis for taking extra precautions to ensure medication safety in those ...
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2018-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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