Delta-8-THC vs. Delta-9-THC on Simulated Driving Performance

Johns Hopkins University

Status and phase: Enrolling; Phase 1

Conditions: Cannabis

Treatments: Drug: Delta-8-THC; Drug: Delta-9-THC; Drug: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06218550

IRB00394164

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Be between the ages of 18 and 55
2. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
3. Test negative for recent cannabis use prior to each experimental test session
4. Test negative for drugs of abuse and alcohol prior to each experimental test session
5. Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission
6. Have a body mass index (BMI) in the range of 19 to 36 kg/m2
7. Report use of cannabis in the past 3 years (both sub-studies) and prior experience inhaling cannabis (either via smoking or vaporization) for vaporization sub-study participation
8. Have not donated blood in the prior 30 days.
9. Have a current government-issued driver's license

Exclusion criteria

1. Non-medical use of psychoactive drugs other than nicotine, alcohol, or caffeine in the month prior to study participation.
2. History of or current evidence of health issues judged by the investigator to put the participant at greater risk of experiencing an adverse event due to drug exposure or completion of other study procedures.
3. Current concomitant medication use that may interact with the study drug (∆8-THC and ∆9-THC).
4. History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.
5. Participation in other research projects that could impact the present study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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45 participants in 8 patient groups, including a placebo group

Oral Placebo

Placebo Comparator group

Description:

A brownie containing no experimental drugs will be eaten by study participants

Treatment:

Drug: Placebo

Oral administration of 30mg ∆8-THC

Experimental group

Description:

A brownie infused with 30mg ∆8-THC will be eaten by study participants

Treatment:

Drug: Delta-8-THC

Oral administration of 60mg ∆8-THC

Experimental group

Description:

A brownie infused with 60mg ∆8-THC will be eaten by study participants

Treatment:

Drug: Delta-8-THC

Oral administration of 30mg ∆9-THC

Experimental group

Description:

A brownie infused with 30mg ∆9-THC will be eaten by study participants

Treatment:

Drug: Delta-9-THC

Administration of vaporized Placebo

Placebo Comparator group

Description:

Participants will inhale ambient air through a handheld vaporizer (minimum 15 "puffs")

Treatment:

Drug: Placebo

Administration of vaporized 30mg ∆8-THC

Experimental group

Description:

Participants will inhale 30mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs")

Treatment:

Drug: Delta-8-THC

Administration of vaporized 60mg ∆8-THC

Experimental group

Description:

Participants will inhale 60mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs")

Treatment:

Drug: Delta-8-THC

Administration of vaporized 30mg ∆9-THC

Experimental group

Description:

Participants will inhale 30mg ∆9-THC using a handheld vaporizer (minimum 15 "puffs")

Treatment:

Drug: Delta-9-THC