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

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Pain

Treatments

Drug: Cannabidiol
Drug: Placebo

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

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

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems