Use of cannabinoid-based medicine among older residential care recipients diagnosed with dementia: study protocol for a double-blind randomised crossover trial.
Aged
Cannabinoids
/ administration & dosage
Cross-Over Studies
Dementia
/ diagnosis
Double-Blind Method
Female
Humans
Male
Medical Marijuana
/ administration & dosage
Mental Status and Dementia Tests
/ statistics & numerical data
Nursing Homes
Pain
/ diagnosis
Pain Measurement
Plant Oils
/ administration & dosage
Quality of Life
Randomized Controlled Trials as Topic
Treatment Outcome
Behavioural and neuropsychiatric symptoms of dementia (BPSD)
Crossover trial
Dementia
Medicinal cannabis
Pain
Quality of life
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
14 Feb 2020
14 Feb 2020
Historique:
received:
16
05
2019
accepted:
18
01
2020
entrez:
16
2
2020
pubmed:
16
2
2020
medline:
15
12
2020
Statut:
epublish
Résumé
Dementia is a neurological condition that affects the cognitive and functional ability of the brain and is the leading cause of disability among those aged 65 years and above. More effective ways to manage dementia symptoms are needed because current treatment options (antidepressants and antipsychotics) can be ineffective and are associated with substantial side effects, including increased rate of mortality. Cannabinoid-based medicine (CBM) has shown an ability to inhibit some symptoms associated with dementia, and the adverse effects are often minimal; yet, little research has explored the use of CBM among this population. To monitor the safety of a purified dose of CBM oil (3:2 delta-9-tetrahydrocannabinol:cannabidiol) on behaviour symptoms, quality of life and discomfort caused by pain. We will carry out an 18-week, randomised, double-blind crossover trial that consists of a 2-week eligibility period, two 6-week treatment cycles, and two 2-week washout periods (between both cycles and after the second treatment cycle). We aim to recruit 50 participants with dementia who are living in residential aged-care facilities. The participants will be randomised into two groups and will receive a dose of either CBM oil or placebo for the first treatment cycle and the opposite medication for the second. Data will be collected using the Neuropsychiatric Inventory Questionnaire, the Cohen-Mansfield Agitation Inventory, the Quality of Life in Alzheimer's Disease questionnaire, and the Abbey Pain Scale on seven occasions. These will be completed by the participants, aged-care staff, and nominated next of kin or family members. The participants' heart rate and blood pressure will be monitored weekly, and their body composition and weight will be monitored fortnightly by a research nurse, to assess individual dose response and frailty. In addition, pre- and post-surveys will be administered to aged-care staff and family members to understand their perceptions of CBM and to inform proposed focus groups consisting of the aged-care staff and next of kin. The study design has been informed by medical professionals and key stakeholders, including those working in the residential aged-care industry to ensure patient safety, collection of non-invasive measures, and methodological rigor and study feasibility. Australian New Zealand Clinical Trials Registry, ACTRN12619000474156. Registered on 21 March 2019.
Sections du résumé
BACKGROUND
BACKGROUND
Dementia is a neurological condition that affects the cognitive and functional ability of the brain and is the leading cause of disability among those aged 65 years and above. More effective ways to manage dementia symptoms are needed because current treatment options (antidepressants and antipsychotics) can be ineffective and are associated with substantial side effects, including increased rate of mortality. Cannabinoid-based medicine (CBM) has shown an ability to inhibit some symptoms associated with dementia, and the adverse effects are often minimal; yet, little research has explored the use of CBM among this population.
AIM
OBJECTIVE
To monitor the safety of a purified dose of CBM oil (3:2 delta-9-tetrahydrocannabinol:cannabidiol) on behaviour symptoms, quality of life and discomfort caused by pain.
METHODS/DESIGN
METHODS
We will carry out an 18-week, randomised, double-blind crossover trial that consists of a 2-week eligibility period, two 6-week treatment cycles, and two 2-week washout periods (between both cycles and after the second treatment cycle). We aim to recruit 50 participants with dementia who are living in residential aged-care facilities. The participants will be randomised into two groups and will receive a dose of either CBM oil or placebo for the first treatment cycle and the opposite medication for the second. Data will be collected using the Neuropsychiatric Inventory Questionnaire, the Cohen-Mansfield Agitation Inventory, the Quality of Life in Alzheimer's Disease questionnaire, and the Abbey Pain Scale on seven occasions. These will be completed by the participants, aged-care staff, and nominated next of kin or family members. The participants' heart rate and blood pressure will be monitored weekly, and their body composition and weight will be monitored fortnightly by a research nurse, to assess individual dose response and frailty. In addition, pre- and post-surveys will be administered to aged-care staff and family members to understand their perceptions of CBM and to inform proposed focus groups consisting of the aged-care staff and next of kin.
DISCUSSION
CONCLUSIONS
The study design has been informed by medical professionals and key stakeholders, including those working in the residential aged-care industry to ensure patient safety, collection of non-invasive measures, and methodological rigor and study feasibility.
TRIAL REGISTRATION
BACKGROUND
Australian New Zealand Clinical Trials Registry, ACTRN12619000474156. Registered on 21 March 2019.
Identifiants
pubmed: 32059690
doi: 10.1186/s13063-020-4085-x
pii: 10.1186/s13063-020-4085-x
pmc: PMC7023743
doi:
Substances chimiques
Cannabinoids
0
Medical Marijuana
0
Plant Oils
0
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
188Références
Pharm Stat. 2014 Nov-Dec;13(6):376-87
pubmed: 25230245
J Pain Symptom Manage. 2018 Feb;55(2):179-188.e1
pubmed: 28923526
J Psychopharmacol. 2017 Feb;31(2):184-191
pubmed: 27624148
J Formos Med Assoc. 2015 Feb;114(2):147-53
pubmed: 25678176
Int J Palliat Nurs. 2004 Jan;10(1):6-13
pubmed: 14966439
BMC Geriatr. 2015 Oct 19;15:128
pubmed: 26482028
Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007204
pubmed: 19370677
J Clin Psychiatry. 2016 Aug;77(8):1050-64
pubmed: 27561138
J Psychiatr Res. 2016 Sep;80:14-21
pubmed: 27267317
J Psychiatr Res. 1975 Nov;12(3):189-98
pubmed: 1202204
Front Pharmacol. 2014 Mar 05;5:37
pubmed: 24634659
Drug Alcohol Depend. 2017 Mar 01;172:9-13
pubmed: 28088032
Am J Geriatr Psychiatry. 2016 Nov;24(11):1004-1006
pubmed: 27665036
CNS Spectr. 2018 Dec;23(6):361-369
pubmed: 28911339
Cannabis Cannabinoid Res. 2017 Jun 01;2(1):139-154
pubmed: 28861514
Protein Sci. 2017 Nov;26(11):2126-2150
pubmed: 28833749
J Clin Psychopharmacol. 2011 Apr;31(2):256-8
pubmed: 21364345
Psychosom Med. 2002 May-Jun;64(3):510-9
pubmed: 12021425
Psychopharmacology (Berl). 2015 Jul;232(14):2587-95
pubmed: 25752889
BMJ. 2004 Jul 31;329(7460):253
pubmed: 15258006
Int J Geriatr Psychiatry. 2018 Feb;33(2):e280-e285
pubmed: 28940504
Psychopharmacology (Berl). 2006 May;185(4):524-8
pubmed: 16521031
Cannabis Cannabinoid Res. 2019 Sep 23;4(3):214-218
pubmed: 31559336
Mol Pharm. 2006 Nov-Dec;3(6):773-7
pubmed: 17140265
J Altern Complement Med. 2019 Mar;25(3):326-335
pubmed: 30383388
Expert Opin Pharmacother. 2017 Apr;18(6):611-620
pubmed: 28300462
Neurology. 2015 Jun 9;84(23):2338-46
pubmed: 25972490
Lancet Neurol. 2005 Nov;4(11):735-42
pubmed: 16239180
Neuropsychopharmacology. 2004 Feb;29(2):417-26
pubmed: 14583744
Int Psychogeriatr. 2016 Nov;28(11):1761-1774
pubmed: 27345942
Gerontologist. 2005 Oct;45 Spec No 1(1):27-36
pubmed: 16230747
Int Psychogeriatr. 2015 Oct;27(10):1739-47
pubmed: 25899853
Int J Geriatr Psychiatry. 1997 Sep;12(9):913-9
pubmed: 9309469
Isr Med Assoc J. 2017 Feb;19(2):76-78
pubmed: 28457054
J Am Geriatr Soc. 2014 Apr;62(4):762-9
pubmed: 24635665
Curr Neurol Neurosci Rep. 2017 Aug;17(8):56
pubmed: 28631194
Evid Based Complement Alternat Med. 2015;2015:874849
pubmed: 25821504
J Alzheimers Dis. 2014;42(3):973-84
pubmed: 25024327
Am Fam Physician. 2016 Aug 15;94(4):276-82
pubmed: 27548592
Depress Anxiety. 2017 Nov;34(11):1006-1017
pubmed: 28636769
Pharmaceuticals (Basel). 2010 Aug 17;3(8):2689-2708
pubmed: 27713372
JAMA. 2011 Sep 28;306(12):1359-69
pubmed: 21954480
J Am Geriatr Soc. 2015 Jul;63(7):1448-52
pubmed: 26046666
Neurology. 1997 May;48(5 Suppl 6):S10-6
pubmed: 9153155
J Alzheimers Dis. 2016;51(1):15-9
pubmed: 26757043
World J Biol Psychiatry. 2019 Feb;20(2):101-116
pubmed: 28112021
Qual Life Res. 2005 Apr;14(3):675-86
pubmed: 16022061
Qual Life Res. 2014 Mar;23(2):549-59
pubmed: 23975378
Int Psychogeriatr. 2014 Sep 16;:1-17
pubmed: 25226218
Mayo Clin Proc. 2012 Feb;87(2):172-86
pubmed: 22305029
Clin Pharmacol Ther. 2015 Jun;97(6):528-31
pubmed: 25801347
Dtsch Arztebl Int. 2012 Apr;109(15):276-81
pubmed: 22567063
Int J Geriatr Psychiatry. 2008 Jan;23(1):116-7
pubmed: 18081000
J Psychopharmacol. 2014 Nov;28(11):1088-98
pubmed: 25237116
Am J Geriatr Psychiatry. 2014 Apr;22(4):415-9
pubmed: 23597932