Effectiveness of Cannabinoids on Appetite in Scleroderma

NCT05416697 | Completed Phase 3

• 1 other identifier: Cannabinoid in scleroderma
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Systemic Sclerosis; Malnutrition; Loss of Appetite

Keywords

cannabinoid; appetite; quality of life; systemic sclerosis; scleroderma; clinical trial

Outcome Measures

Primary Outcomes (1)

• 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

  4 weeks

Secondary Outcomes (2)

• The changing of serum transferrin level

  4 weeks

• An adverse event

  4 weeks

Other Outcomes (4)

• The changing of sleep quality

  4 weeks

• The changing of quality of life

  4 weeks

• The changing pain symptoms

  4 weeks

Study Arms (2)

cannabinoid

EXPERIMENTAL

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

placeba

PLACEBO COMPARATOR

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

Interventions

CBD oil DRUG

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.

cannabinoid

Placebo DRUG

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.

placeba

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SSc patients aged between 18 and 70 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (2)

Department of Medicine, Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Scleroderma Clinic, Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Related Publications (1)

• Pisprasert V, Sripanichkulchai B, Khannongpho T, Jumnainsong A, Mahakkanukrauh A, Suwannaroj S, Pongkulkiat P, Onchan T, Kanokmedhakul S, So-Ngern A, Foocharoen C. Efficacy of cannabis oil on appetite and quality of life in systemic sclerosis patients: a randomized placebo-controlled trial. J Cannabis Res. 2025 Oct 24;7(1):82. doi: 10.1186/s42238-025-00342-3.

  PMID: 41137182 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic; Malnutrition; Anorexia; Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chingching Foocharoen, M.D.

  Khon Kaen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participant, care provider, and assessor will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: cannabinoid versus placebo

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 13, 2022
• Study Start: November 9, 2022
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)