Effectiveness of Cannabinoids on Appetite in Scleroderma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05416697|
Recruitment Status : Not yet recruiting
First Posted : June 13, 2022
Last Update Posted : November 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Systemic Sclerosis Malnutrition Loss of Appetite||Drug: CBD oil Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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.|
|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|
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
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.
- 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
- 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
- An adverse event [ Time Frame: 4 weeks ]An adverse event
- 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
- 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
- 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
- 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
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
|Contact: Chingching Foocharoen, M.D.||email@example.com|
|Department of Medicine, Faculty of Medicine, Khon Kaen University|
|Khon Kaen, Thailand, 40002|
|Principal Investigator:||Chingching Foocharoen, M.D.||Khon Kaen University|