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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751359
• Other study ID #: 7009
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2016
• Est. completion date: April 2020

Study information

• Verified date: April 2021
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2020
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Cannabidiol
200, 400, or 800 mg Cannabidiol
• Placebo
0 mg Cannabidiol

Locations

Country	Name	City	State
United States	Cooper	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	INSYS Therapeutics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test	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.	Baseline, 60 minutes, 120 minutes 180 minutes, 240 minutes, 300 minutes and 360 minutes after each dose
Secondary	Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales	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.	30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 270 minutes, 300 minutes, 330 minutes, 360 minutes