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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 3, 2019
Sponsor:
Collaborator:
INSYS Therapeutics Inc
Information provided by (Responsible Party):
Ziva D'vora Cooper, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE April 12, 2016
First Posted Date  ICMJE April 26, 2016
Last Update Posted Date April 3, 2019
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2016)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02751359 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2016)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Characterization of the Analgesic Effect of CBD in Healthy, Normal Volunteers
Official Title  ICMJE Characterization of the Analgesic Effects of Oral CBD in Healthy, Normal Volunteers
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Cannabidiol
    200, 400, or 800 mg Cannabidiol
    Other Name: CBD
  • Drug: Placebo
    0 mg Cannabidiol
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Cannabidiol
  • Placebo Comparator: Placebo
    On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 21, 2016)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02751359
Other Study ID Numbers  ICMJE 7009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ziva D'vora Cooper, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE INSYS Therapeutics Inc
Investigators  ICMJE
Principal Investigator: Ziva D Cooper, PhD New York State Psychiatric Institute / CUMC
PRS Account New York State Psychiatric Institute
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP