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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05287256
Recruitment Status : Recruiting
First Posted : March 18, 2022
Last Update Posted : May 27, 2022
Sponsor:
Collaborator:
Substance Abuse and Mental Health Services Administration (SAMHSA)
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Behavioral Pharmacology of Cannabis Drug: Oral Delta-8-THC Cannabis Drug: Oral Delta-9-THC Cannabis Drug: Oral Placebo Drug: Vaporized Delta-8-THC Cannabis Drug: Vaporized Delta-9-THC Cannabis Drug: Vaporized Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 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, Care Provider)
Masking Description: Placebo controlled, double blind drug administration
Primary Purpose: Basic Science
Official Title: Comparative Pharmacokinetic and Pharmacodynamic Effects of Delta-8 and Delta-9 THC
Actual Study Start Date : May 23, 2022
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Dronabinol

Arm Intervention/treatment
Placebo Comparator: Placebo Oral Cannabis
Single acute administration of placebo cannabis baked into a brownie
Drug: Oral Placebo
Placebo will be orally self-administered by study participants

Experimental: Oral administration of 10mg D-8-THC
Single acute administration of cannabis containing 10mg Delta-8-THC baked into a brownie
Drug: Oral Delta-8-THC Cannabis
Delta-8-THC cannabis will be orally self-administered by study participants
Other Name: marijuana

Experimental: Oral administration of 20mg D-8-THC
Single acute administration of cannabis containing 20mg Delta-8-THC baked into a brownie
Drug: Oral Delta-8-THC Cannabis
Delta-8-THC cannabis will be orally self-administered by study participants
Other Name: marijuana

Experimental: Oral administration of 40mg D-8-THC
Single acute administration of cannabis containing 40mg Delta-8-THC baked into a brownie
Drug: Oral Delta-8-THC Cannabis
Delta-8-THC cannabis will be orally self-administered by study participants
Other Name: marijuana

Experimental: Oral administration of 20mg D-9-THC
Single acute administration of cannabis containing 20mg Delta-9-THC baked into a brownie
Drug: Oral Delta-9-THC Cannabis
Delta-9-THC cannabis will be orally self-administered by study participants
Other Name: marijuana

Placebo Comparator: Placebo Vaporized Cannabis
Single acute administration of placebo cannabis via commercial vaporizer
Drug: Vaporized Placebo
Placebo will be self-administered by study participants using a vaporizer

Experimental: Administration of vaporized 10mg D-8-THC
Single acute administration of placebo cannabis containing 10mg Delta-8-THC via commercial vaporizer
Drug: Vaporized Delta-8-THC Cannabis
Delta-8-THC cannabis will be self-administered by study participants using a vaporizer
Other Name: marijuana

Experimental: Administration of vaporized 20mg D-8-THC
Single acute administration of placebo cannabis containing 20mg Delta-8-THC via commercial vaporizer
Drug: Vaporized Delta-8-THC Cannabis
Delta-8-THC cannabis will be self-administered by study participants using a vaporizer
Other Name: marijuana

Experimental: Administration of vaporized 40mg D-8-THC
Single acute administration of placebo cannabis containing 40mg Delta-8-THC via commercial vaporizer
Drug: Vaporized Delta-8-THC Cannabis
Delta-8-THC cannabis will be self-administered by study participants using a vaporizer
Other Name: marijuana

Experimental: Administration of vaporized 20mg D-9-THC
Single acute administration of placebo cannabis containing 20mg Delta-9-THC via commercial vaporizer
Drug: Vaporized Delta-9-THC Cannabis
Delta-9-THC cannabis will be self-administered by study participants using a vaporizer
Other Name: marijuana




Primary Outcome Measures :
  1. Self-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ) [ Time Frame: Within 8 hours ]
    Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect.

  2. Heart rate [ Time Frame: Within 8 hours ]
    Heart rate (beats/minute) will be measured while sitting down using the vitals machine.

  3. Blood Pressure [ Time Frame: Within 8 hours ]
    Blood pressure (mmHg) will be measured while sitting down using the vitals machine.

  4. Divided Attention as assessed by the DAT [ Time Frame: Within 8 hours ]
    Divided Attention Task (DAT), cognitive task administered on the computer to assess divided attention.

  5. Digit Symbol Substitution Task (DSST) score [ Time Frame: Within 8 hours ]
    Digit Symbol Substitution Task, cognitive task administered to assess response speed, sustained attention, visual spatial skills and set shifting.

  6. Paced Auditory Serial Addition Task (PASAT) score [ Time Frame: Within 8 hours ]
    Paced Auditory Serial Addition Task, cognitive task that measures cognitive function by assessing auditory information processing speed and flexibility, as well as calculation ability.

  7. Quantitative levels of D-8-THC in blood [ Time Frame: Within 8 hours ]
    Blood is collected through an intravenous catheter, quantitative results are reported in nanograms per milliliter (ng/ml).

  8. Quantitative levels of D-9-THC in blood [ Time Frame: Within 8 hours ]
    Blood is collected through an intravenous catheter, quantitative results are reported in nanograms per milliliter (ng/ml).

  9. Quantitative levels of D-8-THC in oral fluid [ Time Frame: Within 8 hours ]
    Oral fluid is provided by participant, quantitative results are reported in nanograms per milliliter (ng/ml).

  10. Quantitative levels of D-9-THC in oral fluid [ Time Frame: Within 8 hours ]
    Oral fluid is provided by participant, quantitative results are reported in nanograms per milliliter (ng/ml).

  11. Quantitative levels of D-8-THC in urine [ Time Frame: Within 8 hours ]
    Urine is provided by participant, quantitative results are reported in nanograms per milliliter (ng/ml).

  12. Quantitative levels of D-9-THC in urine [ Time Frame: Within 8 hours ]
    Urine is provided by participant, quantitative results are reported in nanograms per milliliter (ng/ml).

  13. Quantitative levels of D-8-THC in hair [ Time Frame: Within 8 hours ]
    Hair samples are taken from the back of the head, quantitative results are reported in nanograms per milliliter (ng/ml).

  14. Quantitative levels of D-9-THC in hair [ Time Frame: Within 8 hours ]
    Hair samples are taken from the back of the head, quantitative results are reported in nanograms per milliliter (ng/ml).

  15. Behavioral task performance as assessed by the DRUID app [ Time Frame: Within 8 hours ]
    Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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): NCT05287256


Contacts
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Contact: Ryan Vandrey, PhD 410-550-4036 rvandrey@jhmi.edu
Contact: Tory Spindle, PhD 410-550-0529 tspindle@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Behavioral Pharmacology Research Unit Recruiting
Baltimore, Maryland, United States, 21224
Contact: Ryan Vandrey       csl-rpcs@live.johnshopkins.edu   
Principal Investigator: Ryan Vandrey, PhD         
Sponsors and Collaborators
Johns Hopkins University
Substance Abuse and Mental Health Services Administration (SAMHSA)
Investigators
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Principal Investigator: Ryan Vandrey, PhD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT05287256    
Other Study ID Numbers: IRB00321661
First Posted: March 18, 2022    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists