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Effectiveness of Cannabinoids on Appetite in Scleroderma

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ClinicalTrials.gov Identifier: NCT05416697
Recruitment Status : Not yet recruiting
First Posted : June 13, 2022
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
Chingching Foocharoen, Khon Kaen University

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.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Malnutrition Loss of Appetite Drug: CBD oil Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: cannabinoid versus placebo
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: The participant, care provider, and assessor will be blinded.
Primary Purpose: Treatment
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
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
Experimental: cannabinoid
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
Drug: CBD oil
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.

Placebo Comparator: placeba
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
Drug: Placebo
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 Measures :
  1. The changing of appetite [ Time Frame: 4 weeks ]

    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 :
  1. The changing of serum transferrin level [ Time Frame: 4 weeks ]
    The mean difference of serum transferrin level compare to baseline and a comparison between the treatment group and placebo group

  2. An adverse event [ Time Frame: 4 weeks ]
    An adverse event


Other Outcome Measures:
  1. The changing of sleep quality [ Time Frame: 4 weeks ]

    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


  2. The changing of quality of life [ Time Frame: 4 weeks ]

    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


  3. The changing pain symptoms [ Time Frame: 4 weeks ]

    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


  4. The changing of cytokine level (transforming growth factor beta) [ Time Frame: 4 weeks ]
    The changing of cytokine level compare to baseline and a comparison between the treatment group and placebo group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. SSc patients aged between 18 and 65 years
  2. Diagnosed according to ACR/EULAR 2013 classification criteria
  3. Having anorexia or malnutrition status
  4. Must not receive steroid equivalent to prednisolone dose more than 10 mg/d
  5. Must receive a stable dose of steroid, immunosuppressant, and/or vitamin or its supplement within 2 weeks before enrollment
  6. Must stop anxiolytics, hypnotics, or sleeping pills at least 2 weeks before enrollment
  7. Understand and able to read and write the Thai language

Exclusion Criteria:

  1. Overlap with other connective tissue diseases
  2. Pregnancy or lactation
  3. Bedridden and confined to no self-care
  4. Evidence of active malignant disease
  5. Present uncontrolled or severe medical problems including diabetes mellitus, asthma, angina, cardiovascular, thyroid, hepatic, or renal diseases (Cr>1.4 mg/dl)
  6. Present active infection that needs systemic antibiotic
  7. Previous allergy to cannabinoid or their derivatives
  8. Concomitant illegal drug used (amphetamine or its derivative, cocaine)
  9. History of the previous cannabinoid using or concomitant any herbal included cannabinoid used
  10. On-going anxiolytics, hypnotics, or sleeping pills used
  11. In a period that needs immunosuppressant dose adjustment
  12. Having active SSc that needs closed monitoring for disease progression (pulmonary hypertension, proteinuria, microscopic hematuria, digital gangrene, and progressive interstitial lung disease)
  13. Having unstable cardiopulmonary disease (angina, peripheral vascular disease, cerebrovascular disease, and arrhythmia) and risk of cardiovascular disease
  14. Having a history of schizophrenia, concurrent active mood disorder, or anxiety disorders
  15. Receiving the following medications that cause drug interaction with cannabinoids: fluoroquinolone, rifampicin, fluoxetine, warfarin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05416697


Contacts
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Contact: Chingching Foocharoen, M.D. 6643363746 fching@kku.ac.th

Locations
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Thailand
Department of Medicine, Faculty of Medicine, Khon Kaen University
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
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Principal Investigator: Chingching Foocharoen, M.D. Khon Kaen University
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Responsible Party: Chingching Foocharoen, Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT05416697    
Other Study ID Numbers: Cannabinoid in scleroderma
First Posted: June 13, 2022    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chingching Foocharoen, Khon Kaen University:
cannabinoid
appetite
quality of life
systemic sclerosis
scleroderma
clinical trial
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Malnutrition
Sclerosis
Anorexia
Pathologic Processes
Nutrition Disorders
Connective Tissue Diseases
Skin Diseases
Signs and Symptoms, Digestive