Comparative Pharmacokinetic and Pharmacodynamic Effects of Delta-8 and Delta-9 THC

NCT05287256 | Completed Phase 1 FDA Drug

• 1 other identifier: IRB00321661
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The current study will investigate the subjective, physiological, and cognitive performance effects of inhaled and orally ingested Delta-8 tetrahydrocannabinol (THC) in comparison to both placebo and Delta-9 THC. The purpose of this study is to assess the effects of Delta-8 THC as compared to placebo and Delta-9 THC. Oral fluid, urine, blood, and hair specimens will be collected from participants.

Conditions

Behavioral Pharmacology of Cannabis

Outcome Measures

Primary Outcomes (1)

• Self-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ)

  Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect.

  Within 8 hours

Secondary Outcomes (7)

• Behavioral task performance as assessed by the DRUID app

  Within 8 hours

• Quantitative levels of D-9-THC in blood

  Within 8 hours

• Quantitative levels of D-8-THC in blood

  Within 8 hours

• Paced Auditory Serial Addition Task (PASAT) score

  Within 8 hours

• Digit Symbol Substitution Task (DSST) score

  Within 8 hours

Study Arms (10)

Placebo Oral Cannabis

PLACEBO COMPARATOR

Single acute administration of placebo cannabis baked into a brownie

Drug: Oral Placebo

Oral administration of 10mg D-8-THC

EXPERIMENTAL

Single acute administration of cannabis containing 10mg Delta-8-THC baked into a brownie

Drug: Oral Delta-8-THC Cannabis

Oral administration of 20mg D-8-THC

EXPERIMENTAL

Single acute administration of cannabis containing 20mg Delta-8-THC baked into a brownie

Drug: Oral Delta-8-THC Cannabis

Oral administration of 40mg D-8-THC

EXPERIMENTAL

Single acute administration of cannabis containing 40mg Delta-8-THC baked into a brownie

Drug: Oral Delta-8-THC Cannabis

Oral administration of 20mg D-9-THC

EXPERIMENTAL

Single acute administration of cannabis containing 20mg Delta-9-THC baked into a brownie

Drug: Oral Delta-9-THC Cannabis

Placebo Vaporized Cannabis

PLACEBO COMPARATOR

Single acute administration of placebo cannabis via commercial vaporizer

Drug: Vaporized Placebo

Administration of vaporized 10mg D-8-THC

EXPERIMENTAL

Single acute administration of placebo cannabis containing 10mg Delta-8-THC via commercial vaporizer

Drug: Vaporized Delta-8-THC Cannabis

Administration of vaporized 20mg D-8-THC

EXPERIMENTAL

Single acute administration of placebo cannabis containing 20mg Delta-8-THC via commercial vaporizer

Drug: Vaporized Delta-8-THC Cannabis

Administration of vaporized 40mg D-8-THC

EXPERIMENTAL

Single acute administration of placebo cannabis containing 40mg Delta-8-THC via commercial vaporizer

Drug: Vaporized Delta-8-THC Cannabis

Administration of vaporized 20mg D-9-THC

EXPERIMENTAL

Single acute administration of placebo cannabis containing 20mg Delta-9-THC via commercial vaporizer

Drug: Vaporized Delta-9-THC Cannabis

Interventions

Oral Delta-8-THC Cannabis DRUG

Delta-8-THC cannabis will be orally self-administered by study participants

Also known as: marijuana

Oral administration of 10mg D-8-THC; Oral administration of 20mg D-8-THC; Oral administration of 40mg D-8-THC

Oral Delta-9-THC Cannabis DRUG

Delta-9-THC cannabis will be orally self-administered by study participants

Also known as: marijuana

Oral administration of 20mg D-9-THC

Oral Placebo DRUG

Placebo will be orally self-administered by study participants

Placebo Oral Cannabis

Vaporized Delta-8-THC Cannabis DRUG

Delta-8-THC cannabis will be self-administered by study participants using a vaporizer

Also known as: marijuana

Administration of vaporized 10mg D-8-THC; Administration of vaporized 20mg D-8-THC; Administration of vaporized 40mg D-8-THC

Vaporized Delta-9-THC Cannabis DRUG

Delta-9-THC cannabis will be self-administered by study participants using a vaporizer

Also known as: marijuana

Administration of vaporized 20mg D-9-THC

Vaporized Placebo DRUG

Placebo will be self-administered by study participants using a vaporizer

Placebo Vaporized Cannabis

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have provided written informed consent
• Be between the ages of 18 and 45
• 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 in urine at the screening visit and again upon admission for each experimental session
• Test negative for other drugs of abuse, including alcohol at the screening visit and upon arrival for each experimental 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
• Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
• Report prior experience inhaling cannabis (either via smoking or vaporization).
• Have not donated blood in the prior 30 days.

You may not qualify if:

• Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the month prior to the Screening Visit;
• History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
• Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
• Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject. This includes any medication metabolized via CYP2D6, CYP2C9, CYP2B10, or which induce/inhibit CYP3A4 enzymes.
• Use of any hemp, cannabis or cannabinoid product in the past 3 months.
• 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.
• History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
• Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
• Epilepsy or a history of seizures.
• Individuals who have a recent history of traumatic brain injury diagnosed by CT/MRI and have current sequela from prior brain injury, as determined by the study physician.
• Individuals with anemia judged by medical staff to place the person at risk due to the frequency and volume of blood collected during the 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

Interventions

nabiximols

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, CARE PROVIDER
• 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: March 10, 2022
• First Posted: March 18, 2022
• Study Start: May 23, 2022
• Primary Completion: August 8, 2024
• Study Completion: October 2, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)