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

Primary Purpose

Rheumatoid Arthritis, Psoriatic Arthritis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cannabis: placebo and medium THC/medium CBD
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brown University School of Public HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Vaporized cannabis: placebo

Vaporized cannabis: medium THC/medium CBD

Arm Description

Vaporized cannabis: placebo dose

Vaporized cannabis: medium THC/medium CBD dose

Outcomes

Primary Outcome Measures

Change in subjective pain level
short-form McGill Pain Questionnaire (SF-MPQ)

Secondary Outcome Measures

Change in self-reported affect
Positive and Negative Affect Scale (PANAS)
Change in level of Inflammatory biomarkers
Interleukin 6 (IL-6) and Tumor necrosis factor alpha (TNF-α)

Full Information

First Posted
February 12, 2020
Last Updated
May 18, 2022
Sponsor
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT04269993
Brief Title
Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis
Official Title
Impact of Acute Cannabis Administration on Pain Symptomology and Inflammatory Markers Among Patients With Rheumatoid or Psoriatic Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Psoriatic Arthritis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vaporized cannabis: placebo
Arm Type
Placebo Comparator
Arm Description
Vaporized cannabis: placebo dose
Arm Title
Vaporized cannabis: medium THC/medium CBD
Arm Type
Experimental
Arm Description
Vaporized cannabis: medium THC/medium CBD dose
Intervention Type
Drug
Intervention Name(s)
Cannabis: placebo and medium THC/medium CBD
Other Intervention Name(s)
Marijuana
Intervention Description
Vaporized cannabis: placebo and medium THC/medium CBD
Primary Outcome Measure Information:
Title
Change in subjective pain level
Description
short-form McGill Pain Questionnaire (SF-MPQ)
Time Frame
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 Measure Information:
Title
Change in self-reported affect
Description
Positive and Negative Affect Scale (PANAS)
Time Frame
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
Title
Change in level of Inflammatory biomarkers
Description
Interleukin 6 (IL-6) and Tumor necrosis factor alpha (TNF-α)
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 taking any exclusionary medications presence of any severe cardiovascular, renal, or hepatic disorder below 18 or above 65 years of age 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Aston, PhD
Phone
401-863-6668
Email
elizabeth_aston@brown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jane Metrik, PhD
Phone
401-863-6650
Email
jane_metrik@brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Aston, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University School of Public Health
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Aston, PhD
Phone
401-863-6668
Email
elizabeth_aston@brown.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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