Effectiveness of Cannabinoids on Appetite in Scleroderma

NCT ID: NCT05416697

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-09
• Study Completion Date: 2024-12-31

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.

Conditions

Systemic Sclerosis; Malnutrition; Loss of Appetite

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

CBD oil

Intervention Type: 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.

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. SSc patients aged between 18 and 70 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Chingching Foocharoen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chingching Foocharoen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen University

Locations

Department of Medicine, Faculty of Medicine, Khon Kaen University

Khon Kaen, , Thailand

Scleroderma Clinic, Faculty of Medicine, Khon Kaen University

Khon Kaen, , Thailand

Countries

Thailand

References

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.

Reference Type: DERIVED

PMID: 41137182 (View on PubMed)

Other Identifiers

Cannabinoid in scleroderma

Identifier Type: -

Identifier Source: org_study_id