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

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

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.

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis
• Intervention / Treatment: Drug: Cannabis: placebo and medium THC/medium CBD

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Elizabeth Aston, PhD; Phone Number: 401-863-6668; Email: elizabeth_aston@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Brown University School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vaporized cannabis: placebo; Vaporized cannabis: placebo dose	Drug: Cannabis: placebo and medium THC/medium CBD; Vaporized cannabis: placebo and medium THC/medium CBD; Other Names: Marijuana
Experimental: Vaporized cannabis: medium THC/medium CBD; Vaporized cannabis: medium THC/medium CBD dose	Drug: Cannabis: placebo and medium THC/medium CBD; Vaporized cannabis: placebo and medium THC/medium CBD; Other Names: Marijuana

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in level of Inflammatory biomarkers	Interleukin 6 (IL-6) and Tumor necrosis factor alpha (TNF-α)	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

Collaborators and Investigators

• Sponsor: Brown University
• Investigators: Principal Investigator: Elizabeth Aston, PhD, Brown University

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: #1904002430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No