Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1-312-0218758-67045L | Other Grant/Funding Number | SAMHSA/RTI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| RTI International | OTHER |
| Substance Abuse And Mental Health Administration | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This study will evaluate the pharmacokinetic effects of acute and chronic dosing of a hemp-based cannabidiol (CBD) topical lotion with low levels of delta-9-tetrahydrocannabinol (THC) in a sanitized and controlled environment.
Participants (N = 6) will complete an 7-day residential study using a high CBD/low D9-THC lotion. The lotion is applied to the participants' upper arms four times daily in a sanitized and controlled procedure that eliminates the potential for specimen contamination. Oral fluid (OF) is collected before and after application (six samples/day); blood and urine are collected once/day. On discharge day, participants provide an intentionally contaminated OF sample. Participants return after a 7-day washout to provide 4 additional OF specimens, one "clean" and three more intentionally contaminated samples over a two-hour course.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical CBD Product with low level of THC | Experimental | Participants will topically apply a high CBD-product that also contains low levels of THC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD | Drug | CBD will be topically applied |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in concentration of oral fluid cannabinoids | Concentration of cannabinoids will be measured in oral fluid (unit of measurement: nanograms/mL) | Days 1-7 and Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in concentration of blood cannabinoids | Concentration of cannabinoids will be measured in blood (unit of measurement: nanograms/mL) | Days 1-7 and Day 14 |
| Change concentration of urine cannabinoids |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lizzie Wilkerson | Contact | 4105500529 | lizziewilkerson307@gmail.com | |
| Tory Spindle | Contact | tspindle@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tory Spindle, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioral Pharmacology Research Unit | Baltimore | Maryland | 21224 | United States |
Not provided
| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| THC |
| Drug |
THC will be topically applied |
|
Concentration of cannabinoids will be measured in urine (unit of measurement: nanograms/mL)
| Days 1-7 and Day 14 |
| Change in the number of total minutes of sleep | Change in sleep patterns. Change in the number of total minutes of sleep will be measured via vital monitoring and sleep profiling | Days 1-7 |