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

Study Purpose

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 will be administered via vaporization (placebo and medium THC [1-5%]/medium CBD [1-5%]) across two experimental sessions using a counter-balanced, double-blind, crossover design.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. current RA or PA diagnosis with active arthritis not adequately controlled by standard medication. 2. stable prescribed steroid and non-steroidal anti-inflammatory (NSAID) use for at least 1 month and stable use of disease-modifying anti-rheumatic drugs (DMARDS; e.g., tumor necrosis factor inhibitors) for 3 months prior to enrollment (all must be maintained throughout the study) as confirmed by the subject's treating physician. 3. English-speaking. 4. negative urine toxicology screen for cannabis and other drugs. 5. negative pregnancy test. 6. not nursing. 7. use of contraception during the study for women of childbearing age due to potential negative effects of cannabis on a fetus.

Exclusion Criteria:

8. greater than zero breath alcohol concentration. 9. presence of a DSM-5 diagnosis of psychosis or panic disorder as assessed by the Mini International Neuropsychiatric Interview (MINI) and not suicidal [past month ideation or intent] 10. self-report of serious adverse reaction to cannabis in the past year. 11. smoking more than 20 tobacco cigarettes per day. 12. body mass index below 18.5 or above 30 kg/m2 range confirmed during medical exam as extreme BMIs can influence drug blood levels and BMIs in the obese range are considered cardiovascular risk factors. 13. presence of any severe cardiovascular, renal, or hepatic disorder, or history of epilepsy. 14. below 18 or above 65 years of age. 15. absence of lifetime cannabis exposure (reduces the risk of adverse psychoactive effects) 16. use of cannabis in the past 6 months before commencement of study participation and throughout the study as confirmed via urine toxicology screening. 17. below minimum self-reported pain level of 30/100 on a visual analog scale (VAS) pre-study enrollment via telephone and at baseline due to potential variability in pain level

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04269993
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Brown University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Elizabeth Aston, PhD
Principal Investigator Affiliation Brown University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis, Psoriatic Arthritis
Additional Details

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 will be administered via vaporization (placebo and medium THC [1-5%]/medium CBD [1-5%]) 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.

Arms & Interventions

Arms

Placebo Comparator: Vaporized cannabis: placebo

Vaporized cannabis: placebo dose

Experimental: Vaporized cannabis: medium THC/medium CBD

Vaporized cannabis: medium THC/medium CBD dose

Interventions

Drug: - Cannabis: placebo and medium THC/medium CBD

Vaporized cannabis: placebo and medium THC/medium CBD

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Elizabeth Aston, PhD

[email protected]

401-863-6668

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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