Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Substance Abuse and Mental Health Services Administration (SAMHSA) | FED |
Not provided
Not provided
Not provided
Not provided
Delta-8-THC is an isomer of delta-9-THC that has become widely available due to the legalization of hemp and its derivatives. Very little controlled research has been conducted with delta-8-THC and some research suggests it produces similar effects to delta-9-THC, albeit at lower potency. The present study will evaluate the dose effects of delta-8-THC, compared with delta-9-THC, on simulated driving performance, field sobriety tests, cognitive performance, and biomarkers of exposure to cannabinoids. The results will inform policy and education related to impairment due to acute delta-8-THC exposure via vaporization and oral ingestion.
The present study will characterize the acute effects of oral and inhaled ∆8-THC, compared with a positive control dose of ∆9-THC and placebo, on subjective drug effects, cardiovascular effects, cognitive performance, simulated driving performance, field sobriety tests, and drug testing outcomes in oral fluid, blood, hair, and urine. Healthy adults with a history of cannabis use will be recruited to participate in a placebo-controlled, within-subject crossover study at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). The result will be a comparative pharmacology and toxicology dataset for ∆8-THC and ∆9-THC via both oral ingestion and inhalation, two routes of administration that are predominant in retail products currently being sold across the U.S. This study will provide urgently needed data on the behavioral pharmacology and toxicology of ∆8-THC, a novel cannabinoid that is now widely available, but for which there is little public knowledge or public health messaging. This data will directly inform the impact of ∆8-THC use on drug testing programs, and the comparative effects of ∆8-THC to ∆9-THC can be used to inform regulatory decisions related to public safety and the sale of these products.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Placebo | Placebo Comparator | A brownie containing no experimental drugs will be eaten by study participants |
|
| Oral administration of 30mg ∆8-THC | Experimental | A brownie infused with 30mg ∆8-THC will be eaten by study participants |
|
| Oral administration of 60mg ∆8-THC | Experimental | A brownie infused with 60mg ∆8-THC will be eaten by study participants |
|
| Oral administration of 30mg ∆9-THC | Experimental | A brownie infused with 30mg ∆9-THC will be eaten by study participants |
|
| Administration of vaporized Placebo | Placebo Comparator | Participants will inhale ambient air through a handheld vaporizer (minimum 15 "puffs") |
|
| Administration of vaporized 30mg ∆8-THC | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delta-9-THC | Drug | Acute self-administration of inhaled or oral ∆9-THC by healthy adult research volunteers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standard Deviation of Lateral Position (SDLP) in cm | A measure of lane weaving during simulated driving performance, the standard deviation of lateral position is a standard metric of impairment in driving performance. A score of 0 (perfect score, no deviation) is the minimum score possible and there is no upper threshold score. Higher scores equate to worse performance (more lane weaving). | 0-8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Peak Change From Baseline Drug Effect Rating as Assessed by the Drug Effect Questionnaire (DEQ) | Peak rating (0-100) of Drug Effect on the DEQ, a visual analog scale (VAS) self-report questionnaire with 0 being No drug effect and 100 being maximum drug effect | 0-8 hours |
| Mean Peak Change From Baseline Global Impairment Score as assessed by the DRiving Under the Influence of Drugs (DRUID) App |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ryan Vandrey, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Behavioral Pharmacology Research Unit | Baltimore | Maryland | 21224 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| C035731 | delta-8-tetrahydrocannabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
A within-subjects design. At the time of study randomization, participants will be assigned to complete Sub-Study 1 followed by Sub-Study 2, or vice versa, using a counter-balanced randomization sequence. The order in which dose conditions are administered within each sub-study will be randomized across participants because there are too many drug conditions to fully counterbalance dosing within sub-studies at the proposed sample size.
Not provided
Not provided
Placebo controlled, double blind drug administration
Participants will inhale 30mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs") |
|
| Administration of vaporized 60mg ∆8-THC | Experimental | Participants will inhale 60mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs") |
|
| Administration of vaporized 30mg ∆9-THC | Experimental | Participants will inhale 30mg ∆9-THC using a handheld vaporizer (minimum 15 "puffs") |
|
| Delta-8-THC | Drug | Acute self-administration of inhaled or oral ∆8-THC by healthy adult research volunteers |
|
| Placebo | Drug | Consumption of a brownie or inhalation of ambient air through a cannabis vaporizer by health adult research volunteers |
|
Peak Global Impairment score (0-75) recorded as a result of performance on the DRUID App, a brief cognitive task battery completed on a mobile device (e.g., iPad). Larger scores indicate worse performance on the task. |
| 0-8 hours |