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

• ClinicalTrials.gov Identifier: NCT06218550
• Recruitment Status: Not yet recruiting
• First Posted: January 23, 2024
• Last Update Posted: January 23, 2024
• Sponsor: Johns Hopkins University
• Collaborator: Substance Abuse and Mental Health Services Administration (SAMHSA)
• Information provided by (Responsible Party): Johns Hopkins University

Tracking Information

• First Submitted Date: January 11, 2024
• First Posted Date: January 23, 2024
• Last Update Posted Date: January 23, 2024
• Estimated Study Start Date: April 2024
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 11, 2024)

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).

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 11, 2024)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Delta-8-THC vs. Delta-9-THC on Simulated Driving Performance
• Official Title: The Effect of Delta-8-THC vs Delta-9-THC on Simulated Driving Performance and Measures of Impairment
• 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.
• 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, 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.
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

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

• Condition: Cannabis

Intervention

• Drug: Delta-9-THC
  Acute self-administration of inhaled or oral ∆9-THC by healthy adult research volunteers
• Drug: Delta-8-THC
  Acute self-administration of inhaled or oral ∆8-THC by healthy adult research volunteers
• Drug: Placebo
  Consumption of a brownie or inhalation of ambient air through a cannabis vaporizer by health adult research volunteers

Study Arms

• Placebo Comparator: Oral Placebo
  A brownie containing no experimental drugs will be eaten by study participants
  Intervention: Drug: Placebo
• Experimental: Oral administration of 30mg ∆8-THC
  A brownie infused with 30mg ∆8-THC will be eaten by study participants
  Intervention: Drug: Delta-8-THC
• Experimental: Oral administration of 60mg ∆8-THC
  A brownie infused with 60mg ∆8-THC will be eaten by study participants
  Intervention: Drug: Delta-8-THC
• Experimental: Oral administration of 30mg ∆9-THC
  A brownie infused with 30mg ∆9-THC will be eaten by study participants
  Intervention: Drug: Delta-9-THC
• Placebo Comparator: Administration of vaporized Placebo
  Participants will inhale ambient air through a handheld vaporizer (minimum 15 "puffs")
  Intervention: Drug: Placebo
• Experimental: Administration of vaporized 30mg ∆8-THC
  Participants will inhale 30mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs")
  Intervention: Drug: Delta-8-THC
• Experimental: Administration of vaporized 60mg ∆8-THC
  Participants will inhale 60mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs")
  Intervention: Drug: Delta-8-THC
• Experimental: Administration of vaporized 30mg ∆9-THC
  Participants will inhale 30mg ∆9-THC using a handheld vaporizer (minimum 15 "puffs")
  Intervention: Drug: Delta-9-THC

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: January 11, 2024): 45
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2025
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Ryan Vandrey, PhD; 410-550-4036; rvandrey@jhmi.edu

Contact: Tory Spindle, PhD; 410-550-0529; tspindle@jhmi.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06218550
• Other Study ID Numbers: IRB00394164
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Johns Hopkins University
• Original Responsible Party: Same as current
• Current Study Sponsor: Johns Hopkins University
• Original Study Sponsor: Same as current
• Collaborators: Substance Abuse and Mental Health Services Administration (SAMHSA)

Investigators

• Principal Investigator: Ryan Vandrey, PhD; Johns Hopkins University

• PRS Account: Johns Hopkins University
• Verification Date: January 2024