Characterization of the Analgesic Effect of CBD in Healthy, Normal Volunteers

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Cannabidiol

• Registration Number: NCT02751359
• Lead Sponsor: University of California, Los Angeles

Brief Summary

The purpose of this double-blind, placebo-controlled study is to determine the analgesic effects of cannabidiol (CBD), a chemical constituent found in cannabis that does not have intoxicating effects. The analgesic effects of CBD will be assessed using the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for the clinical use of analgesics.

Detailed Description

This within-subject, double-blind, placebo-controlled study will assess the analgesic and subjective effects of a range of CBD doses (0, 200, 400, or 800 mg, po). Volunteers will participate in 4 outpatient laboratory sessions over the course of 4 weeks during which the analgesic effects of CBD will be assessed using the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for the clinical use of analgesics. The order of CBD dose will be randomized across participants. Secondary measures will include subjective and physiologic effects of CBD.

Study Timeline

• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-26
• Study Start: 2016-07
• Primary Completion: 2017-07
• Study Completion: 2020-04
• Status Verified: 2021-04
• Results First Submitted: 2021-04-19
• Results First Submitted QC: 2021-04-19
• Last Update Submitted: 2021-04-19
• Results First Posted: 2021-05-12
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Able to perform study procedures
• Women practicing an effective form of birth control

Exclusion Criteria

• Female subjects who are currently pregnant or breastfeeding.
• Current illicit drug use
• Presence of significant medical illness
• History of heart disease
• Request for drug treatment
• Current parole or probation
• Recent history of significant violent behavior
• Major psychiatric disorder
• Current use of any prescription or over-the-counter medication
• Current pain
• Clinically significant Raynaud's syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)
Active CBD	Cannabidiol	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.

Primary Outcome Measures

Name	Time	Method
Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test	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.

Secondary Outcome Measures

Name	Time	Method
Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales	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.

Trial Locations

Locations (1)

Cooper; 🇺🇸 New York, New York, United States