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

NCT04269993 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: #1904002430P20GM130414
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Subjective Pain Level Post-vaporization

  Short-Form McGill Pain Questionnaire (SF-MPQ) Scale range to describe current pain level: 0 'none' to 10 'worst possible' \*higher scores indicate more severe pain

  at the termination of the cannabis administration procedure (10 minutes post-completion of cannabis administration)

Study Arms (2)

Vaporized cannabis: Placebo then Active THC

EXPERIMENTAL

Participants are randomized to receive placebo cannabis during Session 1 and Active THC cannabis during Session 2; sessions will be separated by at least 2 days

Drug: Cannabis: placebo and medium THC/medium CBD

Vaporized cannabis: Active THC then Placebo

EXPERIMENTAL

Participants are randomized to receive Active THC cannabis during Session 1 and placebo cannabis during Session 2; sessions will be separated by at least 2 days

Drug: Cannabis: placebo and medium THC/medium CBD

Interventions

Cannabis: placebo and medium THC/medium CBD DRUG

Vaporized cannabis was administered to participants (placebo and medium THC/medium CBD).

Also known as: Marijuana

Vaporized cannabis: Active THC then Placebo; Vaporized cannabis: Placebo then Active THC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• current RA or PA diagnosis with active arthritis not adequately controlled by standard medication
• 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)
• English-speaking or Spanish-speaking
• negative urine toxicology screen
• negative pregnancy test
• not nursing
• use of highly effective birth control during the study for both males and females
• prior history of vaping or smoking cannabis

You may not qualify if:

• greater than zero breath alcohol concentration
• presence of psychosis, panic disorder, or suicidal ideation or intent
• self-report of serious adverse reaction to cannabis in the past year
• smoking more than 20 tobacco cigarettes per day
• body mass index below 18.0 or above 33.0 kg/m2 range confirmed during medical exam
• 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
• current diagnosis of dementia or Parkinson's disease
• below cut-off on mental status exam
• current diagnosis of moderate to severe traumatic brain injury
• current diagnosis of epilepsy
• 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)
• past kidney disease (e.g., glomerular nephritis, polycystic kidney disease) and/or presence of elevated creatinine
• 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
• abnormal vital signs
• presence of any severe cardiovascular, renal, or hepatic disorder

Sponsors & Collaborators

• Brown University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Results Point of Contact

• Title: Elizabeth Aston, PhD
• Organization: Brown University

elizabeth_aston@brown.edu

401-863-6668

Study Officials

• Elizabeth Aston, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: May 18, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 1, 2025
• Results First Posted: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)