Clinical trial NCT03832816: Behavioral and Physiological Effects of THC and CBD
Official title: Behavioral and Physiological Effects of delta9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: cortisol
ACTH
Heart rate
delta9-Tetrahydrocannabinol
cannabidiol
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility 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

Primary outcomes:
measure: Change in blood cortisol levels
timeFrame: Prior to drug exposure and for 4 hours post-exposure.
measure: Change in blood Adrenocorticotropic hormone (ACTH) levels
timeFrame: Prior to drug exposure and for 4 hours post-exposure.
measure: Change in heart rate
timeFrame: Prior to drug exposure and for 4 hours post-exposure.
measure: Change in State Anxiety levels as assessed by the State-Trait Anxiety Inventory (STAI)
timeFrame: Prior to drug exposure and for 4 hours post-exposure.
measure: Change in Mood state as assessed by the The Profile of Mood States (POMS)
timeFrame: Prior to drug exposure and for 4 hours post-exposure.
measure: Change in Positive affect levels as assessed by The Positive and Negative Affect Schedule (PANAS)
timeFrame: Prior to drug exposure and for 4 hours post-exposure.
measure: Change in Negative affect levels as assessed by The Positive and Negative Affect Schedule (PANAS)
timeFrame: Prior to drug exposure and for 4 hours post-exposure.
measure: Subjective rating of "Drug Effect" as assessed via the Drug Effect Questionnaire
timeFrame: Prior to drug exposure and for 4 hours post-exposure.
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Elise Weerts, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Ryan Vandrey, PhD
role: PRINCIPAL_INVESTIGATOR
References: