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

Characterization of the Analgesic Effects of Oral CBD in Healthy, Normal Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Cannabidiol; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10013
      • Cooper

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Cannabidiol; 200, 400, or 800 mg Cannabidiol; Other Names: CBD
Placebo Comparator: Placebo; On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)	Drug: Placebo; 0 mg Cannabidiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test	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.	Baseline, 60 minutes, 120 minutes 180 minutes, 240 minutes, 300 minutes and 360 minutes after each dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales	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.	30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 270 minutes, 300 minutes, 330 minutes, 360 minutes

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: INSYS Therapeutics Inc
• Investigators: Principal Investigator: Ziva D Cooper, PhD, New York State Psychiatric Institute / CUMC

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anticonvulsants; Cannabidiol
• Other Study ID Numbers: 7009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO