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Behavioral and Physiological Effects of THC and CBD

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ClinicalTrials.gov Identifier: NCT03832816
Recruitment Status : Withdrawn (cancellation of funding contract)
First Posted : February 6, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This study will evaluate physiological and behavioral responses to vaporized delta9-Tetrahydrocannabinol (THC) and cannabidiol (CBD) administered via inhalation.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Placebo Drug: Vaporized THC alone Drug: Vaporized CBD alone Drug: Vaporized CBD with THC Phase 1

Detailed Description:
The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). In this between-subjects study, participants will be randomized to complete 1 of 8 possible acute drug administration sessions in which participants will administer THC alone, CBD alone, THC and CBD together, or placebo. Following drug administration, participants will complete a performance session and complete a battery of questionnaires assessing subjective drug effects, mood, affect, and mental state. Vital signs and hormone levels will also be assessed before and after drug administration. The study will help the investigators understand the individual and interactive effects of THC and CBD, the two most common cannabis constituents.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: placebo controlled, double-blind
Primary Purpose: Basic Science
Official Title: Behavioral and Physiological Effects of delta9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD)
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Placebo Comparator: Placebo
Distilled Water
Drug: Placebo
Placebo vapor (distilled water)
Other Name: distilled water

Experimental: Vaporized THC alone
5mg pure THC
Drug: Vaporized THC alone
Acute exposure to vaporized THC

Experimental: Vaporized low CBD alone
50mg pure CBD
Drug: Vaporized CBD alone
Acute exposure to vaporized CBD

Experimental: Vaporized medium CBD alone
100mg pure CBD
Drug: Vaporized CBD alone
Acute exposure to vaporized CBD

Experimental: Vaporized high CBD alone
200mg pure CBD
Drug: Vaporized CBD alone
Acute exposure to vaporized CBD

Experimental: Vaporized low CBD with THC
50mg pure CBD paired with 5mg THC
Drug: Vaporized CBD with THC
Acute exposure to vaporized CBD with THC

Experimental: Vaporized medium CBD with THC
100mg pure CBD paired with 5mg THC
Drug: Vaporized CBD with THC
Acute exposure to vaporized CBD with THC

Experimental: Vaporized high CBD with THC
200mg pure CBD paired with 5mg THC
Drug: Vaporized CBD with THC
Acute exposure to vaporized CBD with THC




Primary Outcome Measures :
  1. Change in blood cortisol levels [ Time Frame: Prior to drug exposure and for 4 hours post-exposure. ]
    Peak change in blood cortisol levels in micrograms per deciliter (ug/dl) will be measured

  2. Change in blood Adrenocorticotropic hormone (ACTH) levels [ Time Frame: Prior to drug exposure and for 4 hours post-exposure. ]
    Peak change in blood ACTH levels in picograms per milliliter (pg/ml) will be measured

  3. Change in heart rate [ Time Frame: Prior to drug exposure and for 4 hours post-exposure. ]
    Peak change in rate (in beats per minute)

  4. Change in State Anxiety levels as assessed by the State-Trait Anxiety Inventory (STAI) [ Time Frame: Prior to drug exposure and for 4 hours post-exposure. ]
    Peak change in composite STAI score. Scale consists of 20 items assessing state anxiety levels; each item is on 4 point Likert scale ranging from 1 (not at all) to 4 (almost always). Items are summed to obtain a composite score which can range from 20 to 80 (higher scores indicate more anxiety).

  5. Change in Mood state as assessed by the The Profile of Mood States (POMS) [ Time Frame: Prior to drug exposure and for 4 hours post-exposure. ]
    Peak change in total tension-anxiety sub-scale score for POMS. This sub-scale of the POMS consists of 9 items, each on a 4-point Likert scale ranging from 1 (not at all) to 4 (extremely) which are summed to create a total score of 9 to 36 (higher scores indicate more tension/anxiety).

  6. Change in Positive affect levels as assessed by The Positive and Negative Affect Schedule (PANAS) [ Time Frame: Prior to drug exposure and for 4 hours post-exposure. ]
    Peak change in total positive affect score. This PANAS consists of 20 items assessing positive affect (10 items) and negative affect (10 items). Each item is on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). 10 positive affect items are summed to create a total positive affect score while the 10 negative affect items are summed to create a total negative affect score; higher total scores indicate more positive affect or more negative (i.e., worse) affect.

  7. Change in Negative affect levels as assessed by The Positive and Negative Affect Schedule (PANAS) [ Time Frame: Prior to drug exposure and for 4 hours post-exposure. ]
    Peak change in total negative affect score. This PANAS consists of 20 items assessing positive affect (10 items) and negative affect (10 items). Each item is on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). 10 positive affect items are summed to create a total positive affect score while the 10 negative affect items are summed to create a total negative affect score; higher total scores indicate more positive affect or more negative (i.e., worse) affect.

  8. Subjective rating of "Drug Effect" as assessed via the Drug Effect Questionnaire [ Time Frame: Prior to drug exposure and for 4 hours post-exposure. ]
    Visual Analog Scale rating of subjective drug effect. Score ranges from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have provided written informed consent
  • Be between the ages of 18 and 50
  • Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
  • Willingness to provide urine sample at the screening visit and again upon admission for the experimental session
  • Test negative for recent drug or alcohol use at the screening visit and upon arrival for each experimental session.
  • Not be pregnant or nursing (if female). All females must have a negative pregnancy test at the screening visit and at clinic admission.
  • BMI 18-36
  • 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
  • Occasional/Intermittent cannabis users.
  • Have not donated blood in the prior 30 days.

Exclusion Criteria:

  • Recent non-medical use of psychoactive drugs;
  • History of or current evidence of significant medical or psychiatric illness
  • any condition (as determined by the study physician or investigator) that puts the participant at greater risk.
  • Recent use of an over the counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
  • Recent use of a prescription medication (with the exception of hormonal birth control prescriptions) 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.
  • Recent use of hemp seeds or hemp oil.
  • Recent use of dronabinol (Marinol).
  • History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
  • Recently enrolled in another clinical trial or have recently received any drug as part of a research study.
  • 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
  • 5th grade reading level or lower.
  • Clinically relevant anxiety.
  • Individuals who are night shift workers

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): NCT03832816


Locations
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United States, Maryland
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Elise Weerts, PhD Johns Hopkins University
Principal Investigator: Ryan Vandrey, PhD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03832816     History of Changes
Other Study ID Numbers: IRB00199386
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
cortisol
ACTH
Heart rate
delta9-Tetrahydrocannabinol
cannabidiol
Additional relevant MeSH terms:
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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