Effectiveness of Cannabinoids on Appetite in Scleroderma

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Khon Kaen University

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