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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
28
Delta-8-THC cannabis will be orally self-administered by study participants
Delta-9-THC cannabis will be orally self-administered by study participants
Placebo will be orally self-administered by study participants
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States
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.
Time frame: Within 8 hours
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.
Time frame: Within 8 hours
Quantitative levels of D-9-THC in blood
Blood is collected through an intravenous catheter, quantitative results are reported in nanograms per milliliter (ng/ml).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Within 8 hours
Divided Attention as assessed by the DAT
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Delta-8-THC cannabis will be self-administered by study participants using a vaporizer
Delta-9-THC cannabis will be self-administered by study participants using a vaporizer
Placebo will be self-administered by study participants using a vaporizer
Divided Attention Task (DAT), cognitive task administered on the computer to assess divided attention.
Time frame: Within 8 hours
Heart rate
Heart rate (beats/minute) will be measured while sitting down using the vitals machine.
Time frame: Within 8 hours