Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis
NCT ID: NCT04269993
Last Updated: 2025-04-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2022-05-18
2023-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Vaporized cannabis: Placebo then Active THC
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
Cannabis: placebo and medium THC/medium CBD
Vaporized cannabis was administered to participants (placebo and medium THC/medium CBD).
Vaporized cannabis: Active THC then Placebo
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
Cannabis: placebo and medium THC/medium CBD
Vaporized cannabis was administered to participants (placebo and medium THC/medium CBD).
Interventions
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Cannabis: placebo and medium THC/medium CBD
Vaporized cannabis was administered to participants (placebo and medium THC/medium CBD).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
Yes
Sponsors
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National Institute of General Medical Sciences (NIGMS)
NIH
Brown University
OTHER
Responsible Party
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Elizabeth Aston
Assistant Professor
Principal Investigators
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Elizabeth Aston, PhD
Role: PRINCIPAL_INVESTIGATOR
Brown University
Locations
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Brown University School of Public Health
Providence, Rhode Island, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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#1904002430
Identifier Type: -
Identifier Source: org_study_id
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