Verified January 2016 by New York State Psychiatric Institute
Sponsor:
Collaborator:
INSYS Therapeutics Inc
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT02751359
First received: April 12, 2016
Last updated: April 21, 2016
Last verified: January 2016
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.
| Pain | Drug: Cannabidiol Drug: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Characterization of the Analgesic Effects of Oral CBD in Healthy, Normal Volunteers |
- Subjective drug effects related to abuse liability as measured by visual analog scales [ Time Frame: 2 minutes ] [ Designated as safety issue: No ]
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).
| Estimated Enrollment: | 18 |
| Study Start Date: | May 2016 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| 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 |
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.
| Ages Eligible for Study: | 21 Years to 50 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02751359
New York State Psychiatric Institute
INSYS Therapeutics Inc
| Principal Investigator: | Ziva D Cooper, PhD | New York State Psychiatric Institute / CUMC |
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT02751359 History of Changes |
| Other Study ID Numbers: | 7009 |
| Study First Received: | April 12, 2016 |
| Last Updated: | April 21, 2016 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board United States: Federal Government |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
| Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 13, 2016