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Study protocol
Examining the use of Cannabinoid-based Medicine among older residential care recipients diagnosed with dementia: A study protocol for a double blind randomised cross-over trial
Amanda Timler
University of Notre Dame Australia
Corresponding Author
ORCiD: https://orcid.org/0000-0003-2619-5937
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
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 as current treatment options (anti-depressant and antipsychotic) can be ineffective and associated with substantial side-effects, including increased rate of mortality. Cannabinoid-based medicines (CBM) has shown 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. To monitor the safety of a purified dose of CBM oil (3:2 THC:CBD) on behaviour symptoms, Quality of life (QOL), and discomfort caused by pain. Methods/Design: We will carry out an 18-week randomised, double-blinded, 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 receive a dose of either CBM oil or placebo for the first treatment cycle and receive the opposite medication for the second. The Neuropsychiatric Inventory Questionnaire, Cohen Mansfield Agitation Inventor, Quality of Life-Alzheimer’s Disease questionnaire, and the Abbey Pain Scale will be collected on seven occasions, and completed by the participants, aged-care staff, and nominated next of kin or family member. The participant’s 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 towards CBM, and to inform proposed focus groups consisting of the aged care staff and next of kin. Discussion: 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.
Keywords
Dementia; Medicinal Cannabis; Quality of Life; pain; behavioural and neuropsychiatric symptoms of dementia (BPSD); Crossover trial
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CURRENT STATUS: Published
Version 3
Posted 19 Dec, 2019
Published
On 14 Feb, 2020
No community comments so far
Editorial decision: Accept
On 18 Jan, 2020
Review #2 received
Received 17 Jan, 2020
Reviewer #2 agreed
On 07 Jan, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Reviewer #1 agreed
On 06 Jan, 2020
Review #1 received
Received 06 Jan, 2020
Editor assigned
On 16 Dec, 2019
Submission checks complete
On 15 Dec, 2019
No comments provided
Review #4 received
Received 13 Dec, 2019
Editorial decision: Major revision
On 13 Dec, 2019
Review #3 received
Received 09 Dec, 2019
Review #2 received
Received 20 Nov, 2019
Reviewer #4 agreed
On 18 Nov, 2019
Review #1 received
Received 14 Nov, 2019
Reviewer #2 agreed
On 12 Nov, 2019
Reviewer #3 agreed
On 12 Nov, 2019
Editor assigned
On 08 Nov, 2019
Reviewers invited
Invitations sent on 08 Nov, 2019
Reviewer #1 agreed
On 08 Nov, 2019
Submission checks complete
On 07 Nov, 2019
No comments provided
Reviewer #5 agreed
On 12 Oct, 2019
Review #5 received
Received 12 Oct, 2019
Editorial decision: Major revision
On 12 Oct, 2019
Review #4 received
Received 04 Oct, 2019
Review #3 received
Received 10 Sep, 2019
Review #1 received
Received 10 Sep, 2019
Review #2 received
Received 10 Sep, 2019
Reviewer #2 agreed
On 09 Sep, 2019
Reviewers invited
Invitations sent on 09 Sep, 2019
Reviewer #3 agreed
On 09 Sep, 2019
Reviewer #1 agreed
On 09 Sep, 2019
Reviewer #4 agreed
On 09 Sep, 2019
Editor assigned
On 17 Jul, 2019
Submission checks complete
On 30 May, 2019
First submitted
On 16 May, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Translational Medicine
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Examining the use of Cannabinoid-based Medicine among older residential care recipients diagnosed with dementia: A study protocol for a double blind randomised cross-over trial
Amanda Timler
University of Notre Dame Australia
Corresponding Author
ORCiD: https://orcid.org/0000-0003-2619-5937
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 3
Posted 19 Dec, 2019
Published
On 14 Feb, 2020
No community comments so far
Editorial decision: Accept
On 18 Jan, 2020
Review #2 received
Received 17 Jan, 2020
Reviewer #2 agreed
On 07 Jan, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Reviewer #1 agreed
On 06 Jan, 2020
Review #1 received
Received 06 Jan, 2020
Editor assigned
On 16 Dec, 2019
Submission checks complete
On 15 Dec, 2019
No comments provided
Review #4 received
Received 13 Dec, 2019
Editorial decision: Major revision
On 13 Dec, 2019
Review #3 received
Received 09 Dec, 2019
Review #2 received
Received 20 Nov, 2019
Reviewer #4 agreed
On 18 Nov, 2019
Review #1 received
Received 14 Nov, 2019
Reviewer #2 agreed
On 12 Nov, 2019
Reviewer #3 agreed
On 12 Nov, 2019
Editor assigned
On 08 Nov, 2019
Reviewers invited
Invitations sent on 08 Nov, 2019
Reviewer #1 agreed
On 08 Nov, 2019
Submission checks complete
On 07 Nov, 2019
No comments provided
Reviewer #5 agreed
On 12 Oct, 2019
Review #5 received
Received 12 Oct, 2019
Editorial decision: Major revision
On 12 Oct, 2019
Review #4 received
Received 04 Oct, 2019
Review #3 received
Received 10 Sep, 2019
Review #1 received
Received 10 Sep, 2019
Review #2 received
Received 10 Sep, 2019
Reviewer #2 agreed
On 09 Sep, 2019
Reviewers invited
Invitations sent on 09 Sep, 2019
Reviewer #3 agreed
On 09 Sep, 2019
Reviewer #1 agreed
On 09 Sep, 2019
Reviewer #4 agreed
On 09 Sep, 2019
Editor assigned
On 17 Jul, 2019
Submission checks complete
On 30 May, 2019
First submitted
On 16 May, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Translational Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
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 as current treatment options (anti-depressant and antipsychotic) can be ineffective and associated with substantial side-effects, including increased rate of mortality. Cannabinoid-based medicines (CBM) has shown 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. To monitor the safety of a purified dose of CBM oil (3:2 THC:CBD) on behaviour symptoms, Quality of life (QOL), and discomfort caused by pain. Methods/Design: We will carry out an 18-week randomised, double-blinded, 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 receive a dose of either CBM oil or placebo for the first treatment cycle and receive the opposite medication for the second. The Neuropsychiatric Inventory Questionnaire, Cohen Mansfield Agitation Inventor, Quality of Life-Alzheimer’s Disease questionnaire, and the Abbey Pain Scale will be collected on seven occasions, and completed by the participants, aged-care staff, and nominated next of kin or family member. The participant’s 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 towards CBM, and to inform proposed focus groups consisting of the aged care staff and next of kin. Discussion: 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.
Figure 1