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

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pain

Treatments: Drug: Placebo; Drug: Cannabidiol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02751359

7009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

Active CBD

Active Comparator group

Description:

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.

Treatment:

Drug: Cannabidiol

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo