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| Name | Class |
|---|---|
| Substance Abuse and Mental Health Services Administration (SAMHSA) | FED |
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The current study will investigate the subjective, physiological, and cognitive performance effects of inhaled and orally ingested Delta-8 tetrahydrocannabinol (THC) in comparison to both placebo and Delta-9 THC. The purpose of this study is to assess the effects of Delta-8 THC as compared to placebo and Delta-9 THC. Oral fluid, urine, blood, and hair specimens will be collected from participants.
The current study will investigate the subjective, physiological, and cognitive performance effects of inhaled and orally ingested Delta-8 THC in comparison to both placebo and Delta-9 THC. Delta-8 THC is an cannabinoid that has become widely available for retail sale in the US due to a loophole in the 2018 Farm Bill. Delta-8 THC is an isomer of Delta-9 THC, which is the compound responsible for most of the psychoactive effects associated with cannabis. Prior research, while limited, has indicated that Delta-8 THC is less potent but has comparable pharmacodynamic effects to Delta-9 THC, especially at higher doses. The purpose of this study is to assess the effects of Delta-8 THC as compared to placebo and Delta-9 THC. Oral fluid, urine, blood, and hair specimens will be collected from participants. The investigators will recruit healthy participants between the ages of 18 and 45 who have prior experience using THC but have not used in at least one month. Two sub-studies will be run, with 5 conditions in each study; sub-study 1 will examine the effects of vaporized Delta-8 THC and sub-study 2 will assess the effects of orally ingested Delta-8 THC. Participants can complete both sub-studies but it is not required. There will be a minimum of 5 outpatient drug administration sessions for each participant, with the option to complete 5 more if interested. The investigators will recruit and consent up to 70 participants in order to obtain 20 completers (up to 40 total individuals) for each sub-study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Oral Cannabis | Placebo Comparator | Single acute administration of placebo cannabis baked into a brownie |
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| Oral administration of 10mg D-8-THC | Experimental | Single acute administration of cannabis containing 10mg Delta-8-THC baked into a brownie |
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| Oral administration of 20mg D-8-THC | Experimental | Single acute administration of cannabis containing 20mg Delta-8-THC baked into a brownie |
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| Oral administration of 40mg D-8-THC | Experimental | Single acute administration of cannabis containing 40mg Delta-8-THC baked into a brownie |
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| Oral administration of 20mg D-9-THC | Experimental | Single acute administration of cannabis containing 20mg Delta-9-THC baked into a brownie |
|
| Placebo Vaporized Cannabis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Delta-8-THC Cannabis | Drug | Delta-8-THC cannabis will be orally self-administered by study participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ) | Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect. | Within 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral task performance as assessed by the DRUID app | Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance. | Within 8 hours |
| Quantitative levels of D-9-THC in blood |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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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.
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Placebo controlled, double blind drug administration
| Placebo Comparator |
Single acute administration of placebo cannabis via commercial vaporizer |
|
| Administration of vaporized 10mg D-8-THC | Experimental | Single acute administration of placebo cannabis containing 10mg Delta-8-THC via commercial vaporizer |
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| Administration of vaporized 20mg D-8-THC | Experimental | Single acute administration of placebo cannabis containing 20mg Delta-8-THC via commercial vaporizer |
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| Administration of vaporized 40mg D-8-THC | Experimental | Single acute administration of placebo cannabis containing 40mg Delta-8-THC via commercial vaporizer |
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| Administration of vaporized 20mg D-9-THC | Experimental | Single acute administration of placebo cannabis containing 20mg Delta-9-THC via commercial vaporizer |
|
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| Oral Delta-9-THC Cannabis | Drug | Delta-9-THC cannabis will be orally self-administered by study participants |
|
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| Oral Placebo | Drug | Placebo will be orally self-administered by study participants |
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| Vaporized Delta-8-THC Cannabis | Drug | Delta-8-THC cannabis will be self-administered by study participants using a vaporizer |
|
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| Vaporized Delta-9-THC Cannabis | Drug | Delta-9-THC cannabis will be self-administered by study participants using a vaporizer |
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| Vaporized Placebo | Drug | Placebo will be self-administered by study participants using a vaporizer |
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Blood is collected through an intravenous catheter, quantitative results are reported in nanograms per milliliter (ng/ml). |
| Within 8 hours |
| Quantitative levels of D-8-THC in blood | Blood is collected through an intravenous catheter, quantitative results are reported in nanograms per milliliter (ng/ml). | Within 8 hours |
| Paced Auditory Serial Addition Task (PASAT) score | Paced Auditory Serial Addition Task, cognitive task that measures cognitive function by assessing auditory information processing speed and flexibility, as well as calculation ability. | Within 8 hours |
| Digit Symbol Substitution Task (DSST) score | Digit Symbol Substitution Task, cognitive task administered to assess response speed, sustained attention, visual spatial skills and set shifting. | Within 8 hours |
| Divided Attention as assessed by the DAT | Divided Attention Task (DAT), cognitive task administered on the computer to assess divided attention. | Within 8 hours |
| Heart rate | Heart rate (beats/minute) will be measured while sitting down using the vitals machine. | Within 8 hours |
| ID | Term |
|---|---|
| C587251 | nabiximols |
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