Status:
COMPLETED
Delta-8-THC vs. Delta-9-THC on Simulated Driving Performance
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Substance Abuse and Mental Health Services Administration (SAMHSA)
Conditions:
Cannabis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 so...
Detailed 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, cogni...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06218550
Start Date
July 1 2024
End Date
September 8 2025
Last Update
September 25 2025
Active Locations (1)
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1
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224