Behavioral and Physiological Effects of THC and CBD

August 1, 2019 updated by: Johns Hopkins University

Behavioral and Physiological Effects of delta9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Behavioral Pharmacology Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Prior to drug exposure and for 4 hours post-exposure.
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
Prior to drug exposure and for 4 hours post-exposure.
Change in heart rate
Time Frame: Prior to drug exposure and for 4 hours post-exposure.
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)
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).
Prior to drug exposure and for 4 hours post-exposure.
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).
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)
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.
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)
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.
Prior to drug exposure and for 4 hours post-exposure.
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.
Prior to drug exposure and for 4 hours post-exposure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elise Weerts, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00199386

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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