Effectiveness of Cannabinoids on Appetite in Scleroderma
Primary Purpose
Systemic Sclerosis, Malnutrition, Loss of Appetite
Status
Recruiting
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
CBD oil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Sclerosis focused on measuring cannabinoid, appetite, quality of life, systemic sclerosis, scleroderma, clinical trial
Eligibility Criteria
Inclusion Criteria:
- SSc patients aged between 18 and 65 years
- Diagnosed according to ACR/EULAR 2013 classification criteria
- Having anorexia or malnutrition status
- Must not receive steroid equivalent to prednisolone dose more than 10 mg/d
- Must receive a stable dose of steroid, immunosuppressant, and/or vitamin or its supplement within 2 weeks before enrollment
- Must stop anxiolytics, hypnotics, or sleeping pills at least 2 weeks before enrollment
- Understand and able to read and write the Thai language
Exclusion Criteria:
- Overlap with other connective tissue diseases
- Pregnancy or lactation
- Bedridden and confined to no self-care
- Evidence of active malignant disease
- Present uncontrolled or severe medical problems including diabetes mellitus, asthma, angina, cardiovascular, thyroid, hepatic, or renal diseases (Cr>1.4 mg/dl)
- Present active infection that needs systemic antibiotic
- Previous allergy to cannabinoid or their derivatives
- Concomitant illegal drug used (amphetamine or its derivative, cocaine)
- History of the previous cannabinoid using or concomitant any herbal included cannabinoid used
- On-going anxiolytics, hypnotics, or sleeping pills used
- In a period that needs immunosuppressant dose adjustment
- Having active SSc that needs closed monitoring for disease progression (pulmonary hypertension, proteinuria, microscopic hematuria, digital gangrene, and progressive interstitial lung disease)
- Having unstable cardiopulmonary disease (angina, peripheral vascular disease, cerebrovascular disease, and arrhythmia) and risk of cardiovascular disease
- Having a history of schizophrenia, concurrent active mood disorder, or anxiety disorders
- Receiving the following medications that cause drug interaction with cannabinoids: fluoroquinolone, rifampicin, fluoxetine, warfarin
Sites / Locations
- Department of Medicine, Faculty of Medicine, Khon Kaen UniversityRecruiting
- Scleroderma Clinic, Faculty of Medicine, Khon Kaen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
cannabinoid
placeba
Arm Description
Cannabinoid in form of cannabis 2.7 mg THC 2.5 mg twice daily (1 droplet twice daily; 0.73 mg THC and 0.81 mg CBD/drop, 1.46 mg THC and 1.62 CBD/day) for 1 week then titrate up to 2 droplets twice daily if tolerated (2.92 mg THC and 3.24 CBD per day) and continue the treatment until the end of the study
Placebo 1 droplet twice daily for 1 week then titrate up to 2 droplets twice daily if tolerated and continue the treatment until the end of the study
Outcomes
Primary Outcome Measures
The changing of appetite
50% increase of appetite evaluated by a visual analogue scale (VAS) from 0-100* compared to baseline and a comparison between the treatment group and placebo group
*a higher score, a more appetite
Secondary Outcome Measures
The changing of serum transferrin level
The mean difference of serum transferrin level compare to baseline and a comparison between the treatment group and placebo group
An adverse event
An adverse event
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05416697
Brief Title
Effectiveness of Cannabinoids on Appetite in Scleroderma
Official Title
Effectiveness of Cannabinoid on Appetite, Sleep Quality, Quality of Life, Joint Pain, and Cytokine Level in Systemic Sclerosis Patients: a Randomized Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The cannabinoid has benefits in many aspects but the evidence of the effect of cannabinoids in humans with SSc is limited. We, therefore, would like to investigate the efficacy of cannabinoids on the appetite, sleep efficiency, quality of life, pain, and critical cytokine level in SSc compared with placebo in SSc patients and the adverse events associated with cannabinoids in those patients.
Detailed Description
Systemic sclerosis (SSc) is a connective tissue disease for which skin tightness is the hallmark. The disease is classified into 2 major subsets: limited cutaneous systemic sclerosis (lcSSc) and diffuse cutaneous systemic sclerosis (dcSSc) depending on the extent of skin tightness. Not only the skin tightness but also the internal organs such as the musculoskeletal, kidneys, lungs, heart, and intestines can be involved and associated with a poor outcome. Malnutrition and/or weight loss is a complications in SSc. The complication is possibly related to gastrointestinal involvement, inflammation, immunosuppressant agents, or mood disturbance which can affect the food appetite or eating behavior. As well as sleep quality, sleep disturbance has been reported in SSc patients and the associated factor of sleep disturbance in those patients was gastrointestinal involvement, particularly gastroesophageal reflux disease, the severity of pain, and depressed mood. The cannabinoid is an agent which affects appetite, pain, and sleep quality as mentioned above, hence it would improve the appetite, get a high sleep quality and reduce pain associated with musculoskeletal involvement in SSc patients.
Although cannabinoid has benefit in many aspects, they also resulted in serious adverse events after cannabinoid inhalation, including ischemic stroke related to vasospasm of the cerebral vessel, high cardiac output, cardiac arrhythmias, blood pressure fluctuation, and respiratory tract infection. Acute toxicity has been reported and depended on unit dose, tolerance, and route of cannabinoid use. Cannabis also influenced brain function including memory, and cognitive function, and expanded the risk for psychosis in those who had prolonged use. The symptoms of central nervous system (CNS) toxicity include euphoria, panic, agitation, mood alterations, alteration of perception, loss of social inhibition, muscle incoordination, myoclonic jerking, ataxia, slurred speech, and risk of the suicidal idea. In addition, prolonged high doses of cannabis use can lead to the development of cannabinoid hyperemesis syndrome caused by cyclic hyperemesis, finally resulting in electrolyte disturbances and impaired kidney function.
Because the evidence of the effect of cannabinoids in humans with SSc is limited. We, therefore, would like to investigate the efficacy of cannabinoids on the appetite, sleep efficiency, quality of life, pain, and key cytokine level in SSc compared with placebo in SScpatientst and the adverse events associated with cannabinoids in those patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis, Malnutrition, Loss of Appetite
Keywords
cannabinoid, appetite, quality of life, systemic sclerosis, scleroderma, clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
cannabinoid versus placebo
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The participant, care provider, and assessor will be blinded.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cannabinoid
Arm Type
Experimental
Arm Description
Cannabinoid in form of cannabis 2.7 mg THC 2.5 mg twice daily (1 droplet twice daily; 0.73 mg THC and 0.81 mg CBD/drop, 1.46 mg THC and 1.62 CBD/day) for 1 week then titrate up to 2 droplets twice daily if tolerated (2.92 mg THC and 3.24 CBD per day) and continue the treatment until the end of the study
Arm Title
placeba
Arm Type
Placebo Comparator
Arm Description
Placebo 1 droplet twice daily for 1 week then titrate up to 2 droplets twice daily if tolerated and continue the treatment until the end of the study
Intervention Type
Drug
Intervention Name(s)
CBD oil
Intervention Description
The subjects will receive cannabis 2.7 mg THC 2.5 mg CBD twice daily (1 droplet twice daily; 0.73 mg THC and 0.81 mg CBD/drop, 1.46 mg THC and 1.62 CBD/day) for 1 week then titrate up to 2 droplets twice daily if tolerated (2.92 mg THC and 3.24 CBD per day) and continue the treatment until the end of the study.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The subjects will receive 1 droplet of placebo twice daily then titrate up to 2 droplets twice daily if tolerated and continue the treatment until the end of the study.
Primary Outcome Measure Information:
Title
The changing of appetite
Description
50% increase of appetite evaluated by a visual analogue scale (VAS) from 0-100* compared to baseline and a comparison between the treatment group and placebo group
*a higher score, a more appetite
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The changing of serum transferrin level
Description
The mean difference of serum transferrin level compare to baseline and a comparison between the treatment group and placebo group
Time Frame
4 weeks
Title
An adverse event
Description
An adverse event
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
The changing of sleep quality
Description
The changing of sleep quality evaluated by the Thai Pittsburgh Sleep Quality Index* compare to baseline and a comparison between the treatment group and placebo group
*the score ranges from 0-to 21 and the higher score, the poorer sleep quality
Time Frame
4 weeks
Title
The changing of quality of life
Description
The changing of the quality of life evaluated by EuroQol group 5 dimensions (EQ-5D)* compare to baseline and a comparison between the treatment group and placebo group
*the index composes of 5 dimensions and each dimension includes 3 levels (no problems, some problems, and extreme problems), the higher level of the dimension, the poorer quality of life
Time Frame
4 weeks
Title
The changing pain symptoms
Description
50% decrease of joint pain evaluated by VAS from 0-100* compare to baseline and a comparison between the treatment group and placebo group
*a higher scale, a more pain
Time Frame
4 weeks
Title
The changing of cytokine level (transforming growth factor beta)
Description
The changing of cytokine level compare to baseline and a comparison between the treatment group and placebo group
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
SSc patients aged between 18 and 65 years
Diagnosed according to ACR/EULAR 2013 classification criteria
Having anorexia or malnutrition status
Must not receive steroid equivalent to prednisolone dose more than 10 mg/d
Must receive a stable dose of steroid, immunosuppressant, and/or vitamin or its supplement within 2 weeks before enrollment
Must stop anxiolytics, hypnotics, or sleeping pills at least 2 weeks before enrollment
Understand and able to read and write the Thai language
Exclusion Criteria:
Overlap with other connective tissue diseases
Pregnancy or lactation
Bedridden and confined to no self-care
Evidence of active malignant disease
Present uncontrolled or severe medical problems including diabetes mellitus, asthma, angina, cardiovascular, thyroid, hepatic, or renal diseases (Cr>1.4 mg/dl)
Present active infection that needs systemic antibiotic
Previous allergy to cannabinoid or their derivatives
Concomitant illegal drug used (amphetamine or its derivative, cocaine)
History of the previous cannabinoid using or concomitant any herbal included cannabinoid used
On-going anxiolytics, hypnotics, or sleeping pills used
In a period that needs immunosuppressant dose adjustment
Having active SSc that needs closed monitoring for disease progression (pulmonary hypertension, proteinuria, microscopic hematuria, digital gangrene, and progressive interstitial lung disease)
Having unstable cardiopulmonary disease (angina, peripheral vascular disease, cerebrovascular disease, and arrhythmia) and risk of cardiovascular disease
Having a history of schizophrenia, concurrent active mood disorder, or anxiety disorders
Receiving the following medications that cause drug interaction with cannabinoids: fluoroquinolone, rifampicin, fluoxetine, warfarin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chingching Foocharoen, M.D.
Phone
6643363746
Email
fching@kku.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chingching Foocharoen, M.D.
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Faculty of Medicine, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chingching Foocharoen, MD
Phone
6643363746
Email
fching@kku.ac.th
First Name & Middle Initial & Last Name & Degree
Chingching Foocharoen, MD
Facility Name
Scleroderma Clinic, Faculty of Medicine, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chingching Foocharoen, MD
Phone
6643363746
Email
fching@kku.ac.th
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Cannabinoids on Appetite in Scleroderma
We'll reach out to this number within 24 hrs