Characterization of the Pharmacodynamic Response to Vaped THC

February 9, 2022 updated by: A. Eden Evins, Massachusetts General Hospital
This study aims to characterize the pharmacodynamic response to vaped THC in young adult, occasional cannabis users with respect to outcomes such as stimulation and sedative effects, mood, anxiety, and craving, as well as cognitive and objective outcomes such as heart rate and cortisol changes with THC vs placebo.

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Withdrawn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

Enrollees will include 120 healthy, weekly or greater MJ users, aged 18-55. The study will be conducted according to a double-blind, placebo-controlled, random order, cross-over design, consisting of one 3-hour screening visit and 2 randomized, approximately 6-hour laboratory sessions. At the latter visits (following confirmation of eligibility), subjects will complete baseline questionnaires and assessments, including a driver simulator test, a blood draw, vitals, and an imaging session using functional near-infrared spectroscopy (fNIRS). Subjects will then vape a first dose (either THC or placebo based on randomization). Vitals and questionnaires will then be administered throughout the visit, at baseline, and at approximately 15, 60, 90, 130, 165, and 210 minutes post initial dose. Subjects will also perform fNIRS testing at baseline, 30, and 180 minutes and driver simulator at baseline, 60, and 90 minutes post initial THC/placebo administration. A drug recognition expert (DRE) will conduct a standard field sobriety test to identify impairment at approximately 130 minutes post dose. Following the initial dose vaped at 0 minutes, standardized reduced doses will be vaped approximately 30, 60, and 90 minutes later. Given the cross-over design of this study, participants will be assigned to receive THC or placebo at the first laboratory visit and will receive the other substance at the second laboratory visit.

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 3

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women aged 18-55 years, inclusive.
  • Competent and willing to provide written informed consent.
  • Able to communicate in English language.
  • Regular, at least weekly on average, marijuana use
  • Self-reported ability to abstain from cannabis for 24 hours without withdrawal.

Exclusion Criteria:

  • Any unstable, serious medical illness or cardiovascular disease/events.
  • New or unstable psychiatric symptoms, schizophrenia, or bipolar I disorder.
  • Diabetes, cirrhosis, renal failure, Hepatitis C, or HIV.
  • History of syncope without an identified situational stressor, migraines >1x/month, or head injury with prolonged unconsciousness (> 24 hours).
  • Daily use of benzodiazepines or barbiturates, antihistamines, atropine, scopolamine, or other strong anticholinergic agents.
  • Current pregnancy, lactation or trying to become pregnant (confirmed by urine pregnancy test).
  • History of substance abuse treatment and intent to quit or receiving treatment for cannabis use.
  • Affective disorder in the past month or history of panic attacks.
  • Smoking more than 10 tobacco cigarettes or equivalent e-cigarettes a day.
  • In the opinion of the investigator, not able to safely participate in this study.

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: Crossover Assignment
  • Masking: Triple

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.
Experimental: THC
A standard dose of THC (8 mg or 2 mg) will be placed in a Volcano Vaporizer chamber. The first THC dose is 8 mg, followed by approximately three doses of 2 mg each.
Drug: THC or Placebo
A standard dose of THC (8 mg or 2 mg) will be placed in a Volcano Vaporizer chamber. The first THC dose is 8 mg, followed by approximately three doses of 2 mg each. Placebo will also be administered through a Volcano Vaporizer via inhalation. The first placebo dose is 8 mg, followed by approximately three doses of 2 mg each to match the THC procedures.
Placebo Comparator: Placebo
Placebo will also be administered through a Volcano Vaporizer via inhalation. The first placebo dose is 8 mg, followed by approximately three doses of 2 mg each to match the THC procedures.
Drug: THC or Placebo
A standard dose of THC (8 mg or 2 mg) will be placed in a Volcano Vaporizer chamber. The first THC dose is 8 mg, followed by approximately three doses of 2 mg each. Placebo will also be administered through a Volcano Vaporizer via inhalation. The first placebo dose is 8 mg, followed by approximately three doses of 2 mg each to match the THC procedures.

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 Drug Effects Questionnaire
Time Frame: Pre-dose, and 15, 60, 90, 130, 165, 210 minutes post dose
This 15-item questionnaire measures drug effects, behavioral/mood states, and craving. Each item is scored from 0-100, and all items are averaged for a total score from 0-100 with higher scores indicating greater drug effect.
Pre-dose, and 15, 60, 90, 130, 165, 210 minutes post dose
Change in Biphasic Alcohol Effects Scale (Modified for THC)
Time Frame: Pre-dose, and 15, 60, 90, 130, 165, 210 minutes post dose
This 14-item questionnaire measures stimulation and sedation. The Stimulation subscale scores range from 7-70 with higher scores indicating greater stimulation. The Sedation subscale scores range from 7-70 with higher scores indicating greater sedation.
Pre-dose, and 15, 60, 90, 130, 165, 210 minutes post dose
Change in The Spielberger State Anxiety Inventory
Time Frame: Pre-dose, and 15, 60, 90, 130, 165, 210 minutes post dose
This 20-item questionnaire measures state/current anxiety. Scores range from 20-80 with higher scores indicating greater state anxiety.
Pre-dose, and 15, 60, 90, 130, 165, 210 minutes post dose
Change in Driving Simulation Performance on the Divided Attention Task (DAT)
Time Frame: Pre-dose, and 60 and 90 minutes post dose
A computer-programmed driving simulator will assess DAT performance using percentage impaired (from 0-100%).
Pre-dose, and 60 and 90 minutes post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Functional Near-Infrared Spectroscopy (fNIRS) Brain Signal
Time Frame: Pre-dose, and 30 and 180 minutes post dose
fNIRS measures oxygenated hemoglobin (HbO) during both resting state and a working memory task in both THC and placebo conditions.
Pre-dose, and 30 and 180 minutes post dose

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.
Massachusetts General Hospital

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: Eden Evins, MD, MPH, Massachusetts General Hospital

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.
November 1, 2022

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.
October 1, 2025

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.
October 1, 2025

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).
March 23, 2020

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.
April 7, 2020

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.
April 9, 2020

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.
February 11, 2022

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.
February 9, 2022

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.
February 1, 2022

More Information

Terms related to this study

Keywords

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.
  • 2020P000055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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