Behavioral and Physiological Effects of THC and CBD

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.

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

- Provide negative urine test for recent cannabis use at the screening visit and again
upon admission for the experimental session

- Test negative for other drugs of abuse (via urine sample) and alcohol (via breath
sample) 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 18 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.

Exclusion Criteria:

- Non-medical use of psychoactive drugs (including cannabis/CBD) 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 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 hemp seeds or hemp oil in any form in the past 3 months.

- Use of dronabinol (Marinol) within the past 3 months.

- 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

- 5th grade reading level or lower as determined by the Shipley-2 vocabulary score < 18

- Score of 36 or higher on Beck Anxiety Inventory (BAI) at screening.

- Individuals who are night shift workers