Trial Outcomes & Findings for Characterization of the Analgesic Effect of CBD in Healthy, Normal Volunteers (NCT NCT02751359)
NCT ID: NCT02751359
Last Updated: 2021-05-12
Results Overview
Time to first feel pain ("Pain threshold" measured in seconds) during the Cold Pressor Test and withdraw the hand from the cold water ("Pain Tolerance" measured in seconds). Changes in threshold from baseline were averaged across study sessions for each CBD dose.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Baseline, 60 minutes, 120 minutes 180 minutes, 240 minutes, 300 minutes and 360 minutes after each dose
Results posted on
2021-05-12
Participant Flow
Participant milestones
| Measure |
Single Group - Repeated Measures
Each subject will receive each active dose of cannabidiol, one active dose per 3 of the 4 study day; on 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg).
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Single Group - Repeated Measures
Each subject will receive each active dose of cannabidiol, one active dose per 3 of the 4 study day; on 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg).
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|---|---|
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Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Characterization of the Analgesic Effect of CBD in Healthy, Normal Volunteers
Baseline characteristics by cohort
| Measure |
Single Group - Repeated Measures
n=17 Participants
Each subject will receive each active dose of cannabidiol, one active dose per 3 of the 4 study day; on 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg).
|
|---|---|
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Age, Continuous
|
32 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 60 minutes, 120 minutes 180 minutes, 240 minutes, 300 minutes and 360 minutes after each doseTime to first feel pain ("Pain threshold" measured in seconds) during the Cold Pressor Test and withdraw the hand from the cold water ("Pain Tolerance" measured in seconds). Changes in threshold from baseline were averaged across study sessions for each CBD dose.
Outcome measures
| Measure |
Active CBD 200 mg
n=17 Participants
Cannabidiol: 200mg
|
Active CBD 400 mg
n=17 Participants
Cannabidiol: 400mg
|
Active CBD 800 mg
n=17 Participants
Cannabidiol: 800mg
|
Placebo
n=17 Participants
On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)
Placebo: 0 mg Cannabidiol
|
|---|---|---|---|---|
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Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test
Threshold
|
9.7 Seconds
Standard Error 7.0
|
2.2 Seconds
Standard Error 0.8
|
2.1 Seconds
Standard Error 2.4
|
1.2 Seconds
Standard Error 0.9
|
|
Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test
Tolerance
|
5.1 Seconds
Standard Error 5.3
|
15.3 Seconds
Standard Error 8.0
|
-0.6 Seconds
Standard Error 0.9
|
9.6 Seconds
Standard Error 5.3
|
SECONDARY outcome
Timeframe: 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 270 minutes, 300 minutes, 330 minutes, 360 minutesParticipants rate the strength of their desire to take again, drug liking, good effect and bad effect. Each item was presented and the participant was asked to rate his / her rating on a scale anchored by 'Not At All' (0 mm) to 'Extremely' (100 mm). The average of all timepoints is reported for each category.
Outcome measures
| Measure |
Active CBD 200 mg
n=17 Participants
Cannabidiol: 200mg
|
Active CBD 400 mg
n=17 Participants
Cannabidiol: 400mg
|
Active CBD 800 mg
n=17 Participants
Cannabidiol: 800mg
|
Placebo
n=17 Participants
On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)
Placebo: 0 mg Cannabidiol
|
|---|---|---|---|---|
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Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales
Good effect
|
8.7 score on a scale
Standard Error 3.8
|
19.0 score on a scale
Standard Error 5.9
|
10.2 score on a scale
Standard Error 4.7
|
13.3 score on a scale
Standard Error 5.7
|
|
Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales
Bad effect
|
5.7 score on a scale
Standard Error 3.5
|
9.1 score on a scale
Standard Error 4.4
|
4.5 score on a scale
Standard Error 2.2
|
4.1 score on a scale
Standard Error 2.5
|
|
Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales
Drug liking
|
18.7 score on a scale
Standard Error 5.2
|
21.3 score on a scale
Standard Error 5.7
|
15.8 score on a scale
Standard Error 5.1
|
18.8 score on a scale
Standard Error 6.1
|
|
Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales
Desire to take again
|
17.9 score on a scale
Standard Error 5.7
|
23.6 score on a scale
Standard Error 6.6
|
18.1 score on a scale
Standard Error 5.9
|
17.5 score on a scale
Standard Error 6.1
|
Adverse Events
Active CBD 200 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Active CBD 400 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Active CBD 800 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active CBD 200 mg
n=18 participants at risk
Cannabidiol: 200mg
|
Active CBD 400 mg
n=18 participants at risk
Cannabidiol: 400mg
|
Active CBD 800 mg
n=17 participants at risk
Cannabidiol: 800mg
|
Placebo
n=18 participants at risk
On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)
Placebo: 0 mg Cannabidiol
|
|---|---|---|---|---|
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General disorders
Lethargy
|
27.8%
5/18 • During and after each study session, average of 4 weeks total study participation
|
27.8%
5/18 • During and after each study session, average of 4 weeks total study participation
|
29.4%
5/17 • During and after each study session, average of 4 weeks total study participation
|
27.8%
5/18 • During and after each study session, average of 4 weeks total study participation
|
|
Gastrointestinal disorders
Gas and cramps
|
5.6%
1/18 • During and after each study session, average of 4 weeks total study participation
|
22.2%
4/18 • During and after each study session, average of 4 weeks total study participation
|
23.5%
4/17 • During and after each study session, average of 4 weeks total study participation
|
5.6%
1/18 • During and after each study session, average of 4 weeks total study participation
|
|
General disorders
Subtle mood change
|
0.00%
0/18 • During and after each study session, average of 4 weeks total study participation
|
0.00%
0/18 • During and after each study session, average of 4 weeks total study participation
|
0.00%
0/17 • During and after each study session, average of 4 weeks total study participation
|
5.6%
1/18 • During and after each study session, average of 4 weeks total study participation
|
|
Renal and urinary disorders
Frequent urination
|
0.00%
0/18 • During and after each study session, average of 4 weeks total study participation
|
5.6%
1/18 • During and after each study session, average of 4 weeks total study participation
|
0.00%
0/17 • During and after each study session, average of 4 weeks total study participation
|
0.00%
0/18 • During and after each study session, average of 4 weeks total study participation
|
|
General disorders
Wooziness
|
0.00%
0/18 • During and after each study session, average of 4 weeks total study participation
|
5.6%
1/18 • During and after each study session, average of 4 weeks total study participation
|
5.9%
1/17 • During and after each study session, average of 4 weeks total study participation
|
0.00%
0/18 • During and after each study session, average of 4 weeks total study participation
|
Additional Information
Dr. Ziva Cooper, Principal Investigator
University of California Los Angeles
Phone: 310-206-9942
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place