Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| INSYS Therapeutics Inc | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active CBD | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | 200, 400, or 800 mg Cannabidiol |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ziva D Cooper, PhD | New York State Psychiatric Institute / CUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper | New York | New York | 10013 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Single Group - Repeated Measures | Each subject will receive each active dose of cannabidiol, one active dose per 3 of the 4 study day; on 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographics were collected for study completers
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Single Group - Repeated Measures | Each subject will receive each active dose of cannabidiol, one active dose per 3 of the 4 study day; on 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | Seconds | Baseline, 60 minutes, 120 minutes 180 minutes, 240 minutes, 300 minutes and 360 minutes after each dose |
|
During and after each study session, average of 4 weeks total study participation
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active CBD 200 mg | Cannabidiol: 200mg | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lethargy | General disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ziva Cooper, Principal Investigator | University of California Los Angeles | 310-206-9942 | zcooper@mednet.ucla.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2021 | Apr 14, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 0 mg Cannabidiol |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Active CBD 800 mg |
Cannabidiol: 800mg |
| OG003 | Placebo | On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg) Placebo: 0 mg Cannabidiol |
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 270 minutes, 300 minutes, 330 minutes, 360 minutes |
|
|
|
| 18 |
| 0 |
| 18 |
| 5 |
| 18 |
| EG001 | Active CBD 400 mg | Cannabidiol: 400mg | 0 | 18 | 0 | 18 | 10 | 18 |
| EG002 | Active CBD 800 mg | Cannabidiol: 800mg | 0 | 17 | 0 | 17 | 7 | 17 |
| EG003 | Placebo | On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg) Placebo: 0 mg Cannabidiol | 0 | 18 | 0 | 18 | 7 | 18 |
| Gas and cramps | Gastrointestinal disorders | Non-systematic Assessment |
|
| Subtle mood change | General disorders | Non-systematic Assessment |
|
| Frequent urination | Renal and urinary disorders | Non-systematic Assessment |
|
| Wooziness | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Bad effect |
|
| Drug liking |
|
| Desire to take again |
|