Trial Outcomes & Findings for Vaporized Cannabis for Chronic Pain Associated With Sickle Cell Disease (NCT NCT01771731)
NCT ID: NCT01771731
Last Updated: 2020-08-18
Results Overview
Visual analog scale (VAS) used to assess pain. The scale range is 0-100, lower score means lower pain, higher score means higher pain.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Day 1 and Day 5
Results posted on
2020-08-18
Participant Flow
Participant milestones
| Measure |
Cannabis First, Then Placebo
This group received active THC:CBD cannabis during their first 5-day inpatient admission and placebo during the second admission.
|
Placebo First, Then Cannabis
This group received placebo cannabis during their first 5-day inpatient admission and THC:CBD cannabis during the second.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Cannabis First, Then Placebo
This group received active THC:CBD cannabis during their first 5-day inpatient admission and placebo during the second admission.
|
Placebo First, Then Cannabis
This group received placebo cannabis during their first 5-day inpatient admission and THC:CBD cannabis during the second.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Adverse event: Pain Crisis
|
1
|
1
|
Baseline Characteristics
Vaporized Cannabis for Chronic Pain Associated With Sickle Cell Disease
Baseline characteristics by cohort
| Measure |
Cannabis First, Then Placebo
n=13 Participants
Contents of 1 cannabis cigarette (4.7% THC/5.1% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
Contents of 1 placebo cigarette (0% THC/0% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
|
Placebo First, Then Cannabis
n=14 Participants
Contents of 1 placebo cigarette (0% THC/0% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
Contents of 1 cannabis cigarette (4.7% THC/5.1% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
33.3 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
36.4 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 5Population: All participants received both interventions.
Visual analog scale (VAS) used to assess pain. The scale range is 0-100, lower score means lower pain, higher score means higher pain.
Outcome measures
| Measure |
Cannabis
n=23 Participants
Contents of 1 cannabis cigarette (4.7% THC/5.1% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
|
Placebo
n=23 Participants
Contents of 1 placebo cigarette (0% THC/0% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
|
|---|---|---|
|
Pain Rating Using Visual Analog Scale at Day 1 and Day 5
Day 1
|
40.5 score on a scale
Interval 29.3 to 51.7
|
45.8 score on a scale
Interval 34.3 to 57.3
|
|
Pain Rating Using Visual Analog Scale at Day 1 and Day 5
Day 5
|
30.3 score on a scale
Interval 19.0 to 41.6
|
38.5 score on a scale
Interval 28.6 to 48.4
|
Adverse Events
Cannabis
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cannabis
n=23 participants at risk
Contents of 1 cannabis cigarette (4.7% THC/5.1% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
|
Placebo
n=23 participants at risk
Contents of 1 placebo cigarette (0% THC/0% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
|
|---|---|---|
|
Nervous system disorders
Anxiety
|
39.1%
9/23 • Adverse events were collected during the two 5-day admission periods separated by one month
|
30.4%
7/23 • Adverse events were collected during the two 5-day admission periods separated by one month
|
|
Nervous system disorders
Sedation
|
56.5%
13/23 • Adverse events were collected during the two 5-day admission periods separated by one month
|
52.2%
12/23 • Adverse events were collected during the two 5-day admission periods separated by one month
|
|
Nervous system disorders
Disorientation
|
8.7%
2/23 • Adverse events were collected during the two 5-day admission periods separated by one month
|
13.0%
3/23 • Adverse events were collected during the two 5-day admission periods separated by one month
|
|
Nervous system disorders
Paranoia
|
4.3%
1/23 • Adverse events were collected during the two 5-day admission periods separated by one month
|
4.3%
1/23 • Adverse events were collected during the two 5-day admission periods separated by one month
|
|
Nervous system disorders
Confusion
|
8.7%
2/23 • Adverse events were collected during the two 5-day admission periods separated by one month
|
8.7%
2/23 • Adverse events were collected during the two 5-day admission periods separated by one month
|
|
Nervous system disorders
Dizziness
|
26.1%
6/23 • Adverse events were collected during the two 5-day admission periods separated by one month
|
13.0%
3/23 • Adverse events were collected during the two 5-day admission periods separated by one month
|
|
Nervous system disorders
Nausea
|
17.4%
4/23 • Adverse events were collected during the two 5-day admission periods separated by one month
|
26.1%
6/23 • Adverse events were collected during the two 5-day admission periods separated by one month
|
Additional Information
Donald I. Abrams, MD
University of California San Francisco
Phone: 415-476-4082
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place