Pain
Conditions
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.
Interventions
DRUGCannabidiol
200, 400, or 800 mg Cannabidiol
DRUGPlacebo
0 mg Cannabidiol
Sponsors
INSYS Therapeutics Inc
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test | Baseline, 60 minutes, 120 minutes 180 minutes, 240 minutes, 300 minutes and 360 minutes after each dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 270 minutes, 300 minutes, 330 minutes, 360 minutes | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Single Group - Repeated Measures |
|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 17 | 0 / 18 |
| other Total, other adverse events | 5 / 18 | 10 / 18 | 7 / 17 | 7 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 17 | 0 / 18 |
Outcome results
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.
Time frame: Baseline, 60 minutes, 120 minutes 180 minutes, 240 minutes, 300 minutes and 360 minutes after each dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active CBD 200 mg | Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test | Tolerance | 5.1 Seconds | Standard Error 5.3 |
| Active CBD 200 mg | Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test | Threshold | 9.7 Seconds | Standard Error 7 |
| Active CBD 400 mg | Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test | Threshold | 2.2 Seconds | Standard Error 0.8 |
| Active CBD 400 mg | Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test | Tolerance | 15.3 Seconds | Standard Error 8 |
| Active CBD 800 mg | Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test | Threshold | 2.1 Seconds | Standard Error 2.4 |
| Active CBD 800 mg | Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test | Tolerance | -0.6 Seconds | Standard Error 0.9 |
| Placebo | Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test | Tolerance | 9.6 Seconds | Standard Error 5.3 |
| Placebo | Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test | Threshold | 1.2 Seconds | Standard Error 0.9 |
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.
Time frame: 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 270 minutes, 300 minutes, 330 minutes, 360 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active CBD 200 mg | Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | Good effect | 8.7 score on a scale | Standard Error 3.8 |
| Active CBD 200 mg | Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | Drug liking | 18.7 score on a scale | Standard Error 5.2 |
| Active CBD 200 mg | Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | Bad effect | 5.7 score on a scale | Standard Error 3.5 |
| Active CBD 200 mg | Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | Desire to take again | 17.9 score on a scale | Standard Error 5.7 |
| Active CBD 400 mg | Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | Good effect | 19.0 score on a scale | Standard Error 5.9 |
| Active CBD 400 mg | Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | Bad effect | 9.1 score on a scale | Standard Error 4.4 |
| Active CBD 400 mg | Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | Drug liking | 21.3 score on a scale | Standard Error 5.7 |
| Active CBD 400 mg | Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | Desire to take again | 23.6 score on a scale | Standard Error 6.6 |
| Active CBD 800 mg | Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | Drug liking | 15.8 score on a scale | Standard Error 5.1 |
| Active CBD 800 mg | Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | Good effect | 10.2 score on a scale | Standard Error 4.7 |
| Active CBD 800 mg | Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | Desire to take again | 18.1 score on a scale | Standard Error 5.9 |
| Active CBD 800 mg | Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | Bad effect | 4.5 score on a scale | Standard Error 2.2 |
| Placebo | Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | Desire to take again | 17.5 score on a scale | Standard Error 6.1 |
| Placebo | Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | Bad effect | 4.1 score on a scale | Standard Error 2.5 |
| Placebo | Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | Good effect | 13.3 score on a scale | Standard Error 5.7 |
| Placebo | Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales | Drug liking | 18.8 score on a scale | Standard Error 6.1 |