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OpenTrials
Completed

NCT Number: NCT02751359

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

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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Key information

Conditions

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

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cooper

New York, 10013, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cannabidiol

Drug

200, 400, or 800 mg Cannabidiol

Other names: CBD

Placebo

Drug

0 mg Cannabidiol

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • INSYS Therapeutics Inc

Registry information

Official study title

Characterization of the Analgesic Effects of Oral CBD in Healthy, Normal Volunteers

Important dates

Study start
2016
Primary completion
2017
Study completion
2020
First posted
Apr 26, 2016
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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