Phase 2 N=18 Randomized Double-blind Basic Science

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

Pain

Bottom Line

View on ClinicalTrials.gov: NCT02751359 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2021

Primary outcome: Primary: Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test — 9.7; 2.2; 2.1; 1.2 Seconds

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cannabidiol (Drug); Placebo (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: University of California, Los Angeles
Primary completion: Jul 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test	9.7; 2.2; 2.1; 1.2; 5.1; 15.3	—
SECONDARY Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales	8.7; 19.0; 10.2; 13.3; 5.7; 9.1	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02751359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.