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
About this trial
This is an interventional basic science trial for Rheumatoid Arthritis
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
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
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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