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

• Status: Not yet recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brown University

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