Characterization of the Pharmacodynamic Response to Vaped THC

NCT04340700 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 2020P000055
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Vaping; THC

Keywords

Vaping; THC; fNIRS; Cannabis; Imaging

Outcome Measures

Primary Outcomes (4)

• Change in Drug Effects Questionnaire

  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)

  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

  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)

  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 Outcomes (1)

• Change in Functional Near-Infrared Spectroscopy (fNIRS) Brain Signal

  Pre-dose, and 30 and 180 minutes post dose

Study Arms (2)

THC

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

THC or Placebo DRUG

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; THC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Vaping; Marijuana Abuse

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Smoking; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Eden Evins, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Addiction Medicine; Professor in Psychiatry

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 9, 2020
• Study Start: November 1, 2022
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share