Behavioral and Physiological Effects of THC and CBD

Sponsor

Johns Hopkins University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03832816

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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)

Anticipated Study Start Date :

Dec 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Distilled Water	Drug: Placebo Placebo vapor (distilled water) Other Names: 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

Outcome Measures

Primary Outcome Measures

Change in blood cortisol levels [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
Change in blood Adrenocorticotropic hormone (ACTH) levels [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
Change in heart rate [Prior to drug exposure and for 4 hours post-exposure.]
Peak change in rate (in beats per minute)
Change in State Anxiety levels as assessed by the State-Trait Anxiety Inventory (STAI) [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).
Change in Mood state as assessed by the The Profile of Mood States (POMS) [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).
Change in Positive affect levels as assessed by The Positive and Negative Affect Schedule (PANAS) [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.
Change in Negative affect levels as assessed by The Positive and Negative Affect Schedule (PANAS) [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.
Subjective rating of "Drug Effect" as assessed via the Drug Effect Questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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