Characterization of the Analgesic Effect of CBD in Healthy, Normal Volunteers
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|ClinicalTrials.gov Identifier: NCT02751359|
Recruitment Status : Completed
First Posted : April 26, 2016
Results First Posted : May 12, 2021
Last Update Posted : May 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Cannabidiol Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Characterization of the Analgesic Effects of Oral CBD in Healthy, Normal Volunteers|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||April 2020|
Active Comparator: Active CBD
Each subject will receive each active dose of cannabidiol, one active dose per 3 of the 4 study days. The active cannabidiol doses include 200, 400 and 800 mg of cannabidiol.
200, 400, or 800 mg Cannabidiol
Other Name: CBD
Placebo Comparator: Placebo
On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)
0 mg Cannabidiol
- Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test [ Time Frame: Baseline, 60 minutes, 120 minutes 180 minutes, 240 minutes, 300 minutes and 360 minutes after each dose ]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.
- Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales [ Time Frame: 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 270 minutes, 300 minutes, 330 minutes, 360 minutes ]Participants 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751359
|United States, New York|
|New York, New York, United States, 10013|
|Principal Investigator:||Ziva D Cooper, PhD||New York State Psychiatric Institute / CUMC|