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

NCT02751359 | Completed Phase 1 Results

• 1 other identifier: 7009
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Active CBD

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)

Drug: Placebo

Interventions

Cannabidiol DRUG

200, 400, or 800 mg Cannabidiol

Also known as: CBD

Active CBD

Placebo DRUG

0 mg Cannabidiol

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• INSYS Therapeutics Inc: collaborator

Study Sites (1)

Cooper

New York, New York, 10013, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Ziva Cooper, Principal Investigator
• Organization: University of California Los Angeles

zcooper@mednet.ucla.edu

310-206-9942

Study Officials

• Ziva D Cooper, PhD

  New York State Psychiatric Institute / CUMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Neurobiology (in Psychiatry)

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 26, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: April 1, 2020
• Last Updated: May 12, 2021
• Results First Posted: May 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)