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

NCT06218550 | Completed Phase 1 FDA Drug

• 1 other identifier: IRB00394164
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cannabis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Mean Peak Change From Baseline Drug Effect Rating as Assessed by the Drug Effect Questionnaire (DEQ)

  0-8 hours

• Mean Peak Change From Baseline Global Impairment Score as assessed by the DRiving Under the Influence of Drugs (DRUID) App

  0-8 hours

Study Arms (8)

Oral Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Oral administration of 30mg ∆8-THC

EXPERIMENTAL

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

Drug: Delta-8-THC

Oral administration of 60mg ∆8-THC

EXPERIMENTAL

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

Drug: Delta-8-THC

Oral administration of 30mg ∆9-THC

EXPERIMENTAL

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

Drug: Delta-9-THC

Administration of vaporized Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Administration of vaporized 30mg ∆8-THC

EXPERIMENTAL

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

Drug: Delta-8-THC

Administration of vaporized 60mg ∆8-THC

EXPERIMENTAL

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

Drug: Delta-8-THC

Administration of vaporized 30mg ∆9-THC

EXPERIMENTAL

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

Drug: Delta-9-THC

Interventions

Delta-9-THC DRUG

Acute self-administration of inhaled or oral ∆9-THC by healthy adult research volunteers

Administration of vaporized 30mg ∆9-THC; Oral administration of 30mg ∆9-THC

Delta-8-THC DRUG

Acute self-administration of inhaled or oral ∆8-THC by healthy adult research volunteers

Administration of vaporized 30mg ∆8-THC; Administration of vaporized 60mg ∆8-THC; Oral administration of 30mg ∆8-THC; Oral administration of 60mg ∆8-THC

Placebo DRUG

Consumption of a brownie or inhalation of ambient air through a cannabis vaporizer by health adult research volunteers

Administration of vaporized Placebo; Oral Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be between the ages of 18 and 55
• Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
• Test negative for recent cannabis use prior to each experimental test session
• Test negative for drugs of abuse and alcohol prior to each experimental test session
• 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
• Have a body mass index (BMI) in the range of 19 to 36 kg/m2
• 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
• Have not donated blood in the prior 30 days.
• Have a current government-issued driver's license

You may not qualify if:

• Non-medical use of psychoactive drugs other than nicotine, alcohol, or caffeine in the month prior to study participation.
• 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.
• Current concomitant medication use that may interact with the study drug (∆8-THC and ∆9-THC).
• 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.
• Participation in other research projects that could impact the present study

Sponsors & Collaborators

• Johns Hopkins University: lead
• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator

Study Sites (1)

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Dronabinol; delta-8-tetrahydrocannabinol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Ryan Vandrey, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Placebo controlled, double blind drug administration
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 23, 2024
• Study Start: July 1, 2024
• Primary Completion: September 8, 2025
• Study Completion: September 8, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)