Delta-8-THC vs. Delta-9-THC on Simulated Driving Performance
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ClinicalTrials.gov Identifier: NCT06218550 |
Recruitment Status :
Not yet recruiting
First Posted : January 23, 2024
Last Update Posted : January 23, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cannabis | Drug: Delta-9-THC Drug: Delta-8-THC Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | 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. |
Masking: | Double (Participant, Outcomes Assessor) |
Masking Description: | Placebo controlled, double blind drug administration |
Primary Purpose: | Basic Science |
Official Title: | The Effect of Delta-8-THC vs Delta-9-THC on Simulated Driving Performance and Measures of Impairment |
Estimated Study Start Date : | April 2024 |
Estimated Primary Completion Date : | December 2025 |
Estimated Study Completion Date : | December 2025 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Oral Placebo
A brownie containing no experimental drugs will be eaten by study participants
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Drug: Placebo
Consumption of a brownie or inhalation of ambient air through a cannabis vaporizer by health adult research volunteers |
Experimental: Oral administration of 30mg ∆8-THC
A brownie infused with 30mg ∆8-THC will be eaten by study participants
|
Drug: Delta-8-THC
Acute self-administration of inhaled or oral ∆8-THC by healthy adult research volunteers |
Experimental: Oral administration of 60mg ∆8-THC
A brownie infused with 60mg ∆8-THC will be eaten by study participants
|
Drug: Delta-8-THC
Acute self-administration of inhaled or oral ∆8-THC by healthy adult research volunteers |
Experimental: Oral administration of 30mg ∆9-THC
A brownie infused with 30mg ∆9-THC will be eaten by study participants
|
Drug: Delta-9-THC
Acute self-administration of inhaled or oral ∆9-THC by healthy adult research volunteers |
Placebo Comparator: Administration of vaporized Placebo
Participants will inhale ambient air through a handheld vaporizer (minimum 15 "puffs")
|
Drug: Placebo
Consumption of a brownie or inhalation of ambient air through a cannabis vaporizer by health adult research volunteers |
Experimental: Administration of vaporized 30mg ∆8-THC
Participants will inhale 30mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs")
|
Drug: Delta-8-THC
Acute self-administration of inhaled or oral ∆8-THC by healthy adult research volunteers |
Experimental: Administration of vaporized 60mg ∆8-THC
Participants will inhale 60mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs")
|
Drug: Delta-8-THC
Acute self-administration of inhaled or oral ∆8-THC by healthy adult research volunteers |
Experimental: Administration of vaporized 30mg ∆9-THC
Participants will inhale 30mg ∆9-THC using a handheld vaporizer (minimum 15 "puffs")
|
Drug: Delta-9-THC
Acute self-administration of inhaled or oral ∆9-THC by healthy adult research volunteers |
- Standard Deviation of Lateral Position (SDLP) in cm [ Time Frame: 0-8 hours ]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).
- Mean Peak Change From Baseline Drug Effect Rating as Assessed by the Drug Effect Questionnaire (DEQ) [ Time Frame: 0-8 hours ]Peak rating (0-100) of Drug Effect on the DEQ, a visual analog scale (VAS) self-report questionnaire with 0 being No drug effect and 100 being maximum drug effect
- Mean Peak Change From Baseline Global Impairment Score as assessed by the DRUID App [ Time Frame: 0-8 hours ]Peak Global Impairment score (0-75) recorded as a result of performance on the DRUID App, a brief cognitive task battery completed on a mobile device (e.g., iPad). Larger scores indicate worse performance on the task.
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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06218550
Contact: Ryan Vandrey, PhD | 410-550-4036 | rvandrey@jhmi.edu | |
Contact: Tory Spindle, PhD | 410-550-0529 | tspindle@jhmi.edu |
United States, Maryland | |
Johns Hopkins Behavioral Pharmacology Research Unit | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Ryan Vandrey, PhD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT06218550 |
Other Study ID Numbers: |
IRB00394164 |
First Posted: | January 23, 2024 Key Record Dates |
Last Update Posted: | January 23, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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