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

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ClinicalTrials.gov Identifier: NCT02751359
Recruitment Status : Active, not recruiting
First Posted : April 26, 2016
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
INSYS Therapeutics Inc
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Cannabidiol Drug: Placebo Phase 1 Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Characterization of the Analgesic Effects of Oral CBD in Healthy, Normal Volunteers
Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Drug: Cannabidiol
200, 400, or 800 mg Cannabidiol
Other Name: CBD
Placebo Comparator: Placebo
On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)
 Drug: Placebo
0 mg Cannabidiol


Outcome Measures
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Primary Outcome Measures :
  1. Analgesia: Pain tolerance and threshold as measured by the Cold Pressor Test [ Time Frame: 10 minutes ]
    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)


Secondary Outcome Measures :
  1. Subjective drug effects related to abuse liability as measured by visual analog scales [ Time Frame: 2 minutes ]
    Participants rate the strength of the drug effect, drug liking, desire to take again, good effect and bad effect. Each item will be presented and the participant will be asked to rate his / her rating on a scale anchored by 'Not At All' (0 mm) to 'Extremely' (100 mm).


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751359


Locations
United States, New York
Cooper
New York, New York, United States, 10013
Sponsors and Collaborators
New York State Psychiatric Institute
INSYS Therapeutics Inc
Investigators
Principal Investigator: Ziva D Cooper, PhD New York State Psychiatric Institute / CUMC
More Information
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Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02751359     History of Changes
Other Study ID Numbers: 7009
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs