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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2020-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Cannabidiol

Intervention Type DRUG

200, 400, or 800 mg Cannabidiol

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0 mg Cannabidiol

Interventions

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Cannabidiol

200, 400, or 800 mg Cannabidiol

Intervention Type DRUG

Placebo

0 mg Cannabidiol

Intervention Type DRUG

Other Intervention Names

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CBD

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes