Trial Outcomes & Findings for Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis (NCT NCT04269993)
NCT ID: NCT04269993
Last Updated: 2025-04-01
Results Overview
Short-Form McGill Pain Questionnaire (SF-MPQ) Scale range to describe current pain level: 0 'none' to 10 'worst possible' \*higher scores indicate more severe pain
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
at the termination of the cannabis administration procedure (10 minutes post-completion of cannabis administration)
Results posted on
2025-04-01
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
Vaporized Cannabis: Placebo Then Active THC
n=1 Participants
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
|
Vaporized Cannabis: Active THC Then Placebo
n=2 Participants
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
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23 years
n=99 Participants
|
57 years
STANDARD_DEVIATION 1.41 • n=107 Participants
|
45.67 years
STANDARD_DEVIATION 19.66 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at the termination of the cannabis administration procedure (10 minutes post-completion of cannabis administration)Short-Form McGill Pain Questionnaire (SF-MPQ) Scale range to describe current pain level: 0 'none' to 10 'worst possible' \*higher scores indicate more severe pain
Outcome measures
| Measure |
Vaporized Cannabis: Placebo Then Active THC
n=1 Participants
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
|
Vaporized Cannabis: Active THC Then Placebo
n=2 Participants
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
|
|---|---|---|
|
Subjective Pain Level Post-vaporization
Placebo Dose
|
3 score on a scale
|
2 score on a scale
Standard Deviation 1.414
|
|
Subjective Pain Level Post-vaporization
Medium THC/Medium CBD Dose
|
4 score on a scale
|
4.5 score on a scale
Standard Deviation 2.121
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active THC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place