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

NCT ID: NCT05287256

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-23
• Study Completion Date: 2024-10-02

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.

Detailed Description

The current study will investigate the subjective, physiological, and cognitive performance effects of inhaled and orally ingested Delta-8 THC in comparison to both placebo and Delta-9 THC. Delta-8 THC is an cannabinoid that has become widely available for retail sale in the US due to a loophole in the 2018 Farm Bill. Delta-8 THC is an isomer of Delta-9 THC, which is the compound responsible for most of the psychoactive effects associated with cannabis. Prior research, while limited, has indicated that Delta-8 THC is less potent but has comparable pharmacodynamic effects to Delta-9 THC, especially at higher doses. 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. The investigators will recruit healthy participants between the ages of 18 and 45 who have prior experience using THC but have not used in at least one month. Two sub-studies will be run, with 5 conditions in each study; sub-study 1 will examine the effects of vaporized Delta-8 THC and sub-study 2 will assess the effects of orally ingested Delta-8 THC. Participants can complete both sub-studies but it is not required. There will be a minimum of 5 outpatient drug administration sessions for each participant, with the option to complete 5 more if interested. The investigators will recruit and consent up to 70 participants in order to obtain 20 completers (up to 40 total individuals) for each sub-study.

Conditions

Behavioral Pharmacology of Cannabis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo Oral Cannabis

Single acute administration of placebo cannabis baked into a brownie

Group Type: PLACEBO_COMPARATOR

Oral Placebo

Intervention Type: DRUG

Placebo will be orally self-administered by study participants

Oral administration of 10mg D-8-THC

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

Group Type: EXPERIMENTAL

Oral Delta-8-THC Cannabis

Intervention Type: DRUG

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

Oral administration of 20mg D-8-THC

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

Group Type: EXPERIMENTAL

Oral Delta-8-THC Cannabis

Intervention Type: DRUG

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

Oral administration of 40mg D-8-THC

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

Group Type: EXPERIMENTAL

Oral Delta-8-THC Cannabis

Intervention Type: DRUG

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

Oral administration of 20mg D-9-THC

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

Group Type: EXPERIMENTAL

Oral Delta-9-THC Cannabis

Intervention Type: DRUG

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

Placebo Vaporized Cannabis

Single acute administration of placebo cannabis via commercial vaporizer

Group Type: PLACEBO_COMPARATOR

Vaporized Placebo

Intervention Type: DRUG

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

Administration of vaporized 10mg D-8-THC

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

Group Type: EXPERIMENTAL

Vaporized Delta-8-THC Cannabis

Intervention Type: DRUG

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

Administration of vaporized 20mg D-8-THC

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

Group Type: EXPERIMENTAL

Vaporized Delta-8-THC Cannabis

Intervention Type: DRUG

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

Administration of vaporized 40mg D-8-THC

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

Group Type: EXPERIMENTAL

Vaporized Delta-8-THC Cannabis

Intervention Type: DRUG

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

Administration of vaporized 20mg D-9-THC

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

Group Type: EXPERIMENTAL

Vaporized Delta-9-THC Cannabis

Intervention Type: DRUG

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

Interventions

Oral Delta-8-THC Cannabis

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

Intervention Type: DRUG

Oral Delta-9-THC Cannabis

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

Intervention Type: DRUG

Oral Placebo

Placebo will be orally self-administered by study participants

Intervention Type: DRUG

Vaporized Delta-8-THC Cannabis

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

Intervention Type: DRUG

Vaporized Delta-9-THC Cannabis

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

Intervention Type: DRUG

Vaporized Placebo

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

Intervention Type: DRUG

Other Intervention Names

marijuana; marijuana; marijuana; marijuana

Eligibility Criteria

Inclusion Criteria

1. Have provided written informed consent

2. Be between the ages of 18 and 45

3. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests

4. Test negative for recent cannabis use in urine at the screening visit and again upon admission for each experimental session

5. Test negative for other drugs of abuse, including alcohol at the screening visit and upon arrival for each experimental session

6. 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.

7. Have a body mass index (BMI) in the range of 19 to 36 kg/m2

8. 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

9. Report prior experience inhaling cannabis (either via smoking or vaporization).

10. Have not donated blood in the prior 30 days.

Exclusion Criteria

1. Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the month prior to the Screening Visit;

2. 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.

3. 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.

4. 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.

5. Use of any hemp, cannabis or cannabinoid product in the past 3 months.

6. 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.

7. History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).

8. Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.

9. Epilepsy or a history of seizures.

10. 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.

11. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Substance Abuse and Mental Health Services Administration (SAMHSA)

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Vandrey, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00321661

Identifier Type: -

Identifier Source: org_study_id