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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effect of Delta-8-THC vs Delta-9-THC on Simulated Driving Performance and Measures of Impairment

Quick Facts

Study Start:2024-07-01

Study Completion:2025-09-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06218550

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Principal Investigator

Ryan Vandrey, PhD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Ryan Vandrey, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01

Study Completion Date2025-09-08

Study Record Updates

Study Start Date2024-07-01

Study Completion Date2025-09-08

Terms related to this study

Additional Relevant MeSH Terms

Cannabis