Behavioral and Physiological Effects of THC and CBD

NCT03832816 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: IRB00199386
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

cortisol; ACTH; Heart rate; delta9-Tetrahydrocannabinol; cannabidiol

Outcome Measures

Primary Outcomes (8)

• Change in blood cortisol levels

  Peak change in blood cortisol levels in micrograms per deciliter (ug/dl) will be measured

  Prior to drug exposure and for 4 hours post-exposure.

• Change in blood Adrenocorticotropic hormone (ACTH) levels

  Peak change in blood ACTH levels in picograms per milliliter (pg/ml) will be measured

  Prior to drug exposure and for 4 hours post-exposure.

• Change in heart rate

  Peak change in rate (in beats per minute)

  Prior to drug exposure and for 4 hours post-exposure.

• Change in State Anxiety levels as assessed by the State-Trait Anxiety Inventory (STAI)

  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).

  Prior to drug exposure and for 4 hours post-exposure.

• Change in Mood state as assessed by the The Profile of Mood States (POMS)

  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).

  Prior to drug exposure and for 4 hours post-exposure.

• Change in Positive affect levels as assessed by The Positive and Negative Affect Schedule (PANAS)

  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.

  Prior to drug exposure and for 4 hours post-exposure.

• Change in Negative affect levels as assessed by The Positive and Negative Affect Schedule (PANAS)

  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.

  Prior to drug exposure and for 4 hours post-exposure.

• Subjective rating of "Drug Effect" as assessed via the Drug Effect Questionnaire

  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.

  Prior to drug exposure and for 4 hours post-exposure.

Study Arms (8)

Placebo

PLACEBO COMPARATOR

Distilled Water

Drug: Placebo

Vaporized THC alone

EXPERIMENTAL

5mg pure THC

Drug: Vaporized THC alone

Vaporized low CBD alone

EXPERIMENTAL

50mg pure CBD

Drug: Vaporized CBD alone

Vaporized medium CBD alone

EXPERIMENTAL

100mg pure CBD

Drug: Vaporized CBD alone

Vaporized high CBD alone

EXPERIMENTAL

200mg pure CBD

Drug: Vaporized CBD alone

Vaporized low CBD with THC

EXPERIMENTAL

50mg pure CBD paired with 5mg THC

Drug: Vaporized CBD with THC

Vaporized medium CBD with THC

EXPERIMENTAL

100mg pure CBD paired with 5mg THC

Drug: Vaporized CBD with THC

Vaporized high CBD with THC

EXPERIMENTAL

200mg pure CBD paired with 5mg THC

Drug: Vaporized CBD with THC

Interventions

Placebo DRUG

Placebo vapor (distilled water)

Also known as: distilled water

Placebo

Vaporized THC alone DRUG

Acute exposure to vaporized THC

Vaporized THC alone

Vaporized CBD alone DRUG

Acute exposure to vaporized CBD

Vaporized high CBD alone; Vaporized low CBD alone; Vaporized medium CBD alone

Vaporized CBD with THC DRUG

Acute exposure to vaporized CBD with THC

Vaporized high CBD with THC; Vaporized low CBD with THC; Vaporized medium CBD with THC

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• th grade reading level or lower.
• Clinically relevant anxiety.
• Individuals who are night shift workers

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Interventions

Dronabinol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Elise Weerts, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Ryan Vandrey, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: placebo controlled, double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 6, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 5, 2019

Record last verified: 2019-08

Locations

US (1)