Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Impact of Acute Cannabis Administration on Pain Symptomology and Inflammatory Markers Among Patients With Rheumatoid or Psoriatic Arthritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04269993
• Other study ID #: #1904002430
• Status: Terminated
• Phase: Phase 2
• Start date: May 18, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: January 2024
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This laboratory study will investigate the impact of cannabis on pain, affect, and inflammation among patients with rheumatoid or psoriatic arthritis (n = 76). Two cannabis formulations varying in potency will be administered via vaporization across two experimental sessions using a counter-balanced, double-blind, crossover design.

Description:

This laboratory study will investigate the impact of cannabis on pain, affect, and inflammation among patients with rheumatoid or psoriatic arthritis (n = 76). Two cannabis formulations varying in potency will be administered via vaporization across two experimental sessions using a counter-balanced, double-blind, crossover design. Blood will be collected during each session (pre-vaporization, 10 minutes post-vaporization, 60 minutes post-vaporization). Self-reported pain and affect will be assessed at the same time points. The effect of cannabis on pain, affect, and inflammatory biomarkers will be assessed. The study will recruit 76 patients to obtain a final sample of 66 with complete data (15% attrition). This study will be the first to investigate the effect of cannabis on pain, affect, and markers of inflammation among patients with rheumatoid or psoriatic arthritis. This study has the potential to guide clinical decisions pertaining to use of cannabis to treat arthritis symptoms with more precise recommendations regarding cannabis formulation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. current RA or PA diagnosis with active arthritis not adequately controlled by standard medication

2. if taking prescribed steroid, non-steroidal anti-inflammatory (NSAID), and/or disease-modifying anti-rheumatic drug (DMARDS; e.g., tumor necrosis factor inhibitors), must be stable use for at least 1 month prior to enrollment (all must be maintained throughout the study)

3. English-speaking or Spanish-speaking

4. negative urine toxicology screen

5. negative pregnancy test

6. not nursing

7. use of highly effective birth control during the study for both males and females

8. prior history of vaping or smoking cannabis

Exclusion Criteria:

9. greater than zero breath alcohol concentration

10. presence of psychosis, panic disorder, or suicidal ideation or intent

11. self-report of serious adverse reaction to cannabis in the past year

12. smoking more than 20 tobacco cigarettes per day

13. body mass index below 18.0 or above 33.0 kg/m2 range confirmed during medical exam

14. all current asthma conditions (i.e., active symptomatic asthma within the last week) or current or past history of asthma triggered by smoking or vaping

15. current diagnosis of dementia or Parkinson's disease

16. below cut-off on mental status exam

17. current diagnosis of moderate to severe traumatic brain injury

18. current diagnosis of epilepsy

19. individuals who are immunocompromised (i.e., post-organ transplant, those with an immune deficiency disorder such as HIV, individuals taking immunosuppressant steroids such as continuous prednisone use, and those with lupus)

20. past kidney disease (e.g., glomerular nephritis, polycystic kidney disease) and/or presence of elevated creatinine

21. cardiac disease confirmed via clinically significant abnormal findings on an EKG (e.g., arrhythmia, conduction abnormalities, ischemia, or evidence of past myocardial infarction), as well as diagnoses of congestive heart failure or cardiomyopathy

22. abnormal vital signs

23. taking any exclusionary medications

24. presence of any severe cardiovascular, renal, or hepatic disorder

25. below 18 or above 65 years of age

26. use of cannabis in the past 1 month before commencement of study participation and throughout the study as confirmed via urine toxicology screening aa) below minimum self-reported pain level on a visual analog scale (VAS) pre-study enrollment via telephone and at baseline due to potential variability in pain level

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis
• Rheumatoid Arthritis

Intervention

Drug:
• Cannabis: placebo and medium THC/medium CBD
Vaporized cannabis: placebo and medium THC/medium CBD

Locations

Country	Name	City	State
United States	Brown University School of Public Health	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in subjective pain level	short-form McGill Pain Questionnaire (SF-MPQ)	pre-cannabis administration, at the termination of the cannabis administration procedure (10 minutes post-completion of cannabis administration), and 60 minutes post-completion of cannabis administration
Secondary	Change in self-reported affect	Positive and Negative Affect Scale (PANAS)	pre-cannabis administration, at the termination of the cannabis administration procedure (10 minutes post-completion of cannabis administration), and 60 minutes post-completion of cannabis administration
Secondary	Change in level of Inflammatory biomarkers	Interleukin 6 (IL-6) and Tumor necrosis factor alpha (TNF-a)	pre-cannabis administration, at the termination of the cannabis administration procedure (10 minutes post-completion of cannabis administration), and 60 minutes post-completion of cannabis administration