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

• ClinicalTrials.gov Identifier: NCT02751359
• Recruitment Status: Completed
• First Posted: April 26, 2016
• Results First Posted: May 12, 2021
• Last Update Posted: May 12, 2021
• Sponsor: University of California, Los Angeles
• Collaborator: INSYS Therapeutics Inc
• Information provided by (Responsible Party): Ziva D. Cooper, PhD, University of California, Los Angeles

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Cannabidiol; Drug: Placebo	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• 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

Arms and Interventions

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 Name: CBD
Placebo Comparator: Placebo; On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)	Drug: Placebo; 0 mg Cannabidiol

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, New York

Cooper

New York, New York, United States, 10013

Sponsors and Collaborators

University of California, Los Angeles

INSYS Therapeutics Inc

Investigators

• Principal Investigator: Ziva D Cooper, PhD; New York State Psychiatric Institute / CUMC

  Study Documents (Full-Text)

Documents provided by Ziva D. Cooper, PhD, University of California, Los Angeles:

Study Protocol and Statistical Analysis Plan  [PDF] February 23, 2021

More Information

• Responsible Party: Ziva D. Cooper, PhD, Associate Professor of Clinical Neurobiology (in Psychiatry), University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT02751359
• Other Study ID Numbers: 7009
• First Posted: April 26, 2016
• Results First Posted: May 12, 2021
• Last Update Posted: May 12, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Epidiolex; Anticonvulsants