Characterization of the Pharmacodynamic Response to Vaped THC

NCT ID: NCT04340700

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2025-10-01

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.

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.

Conditions

Vaping; THC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

THC or Placebo

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

THC or Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

A. Eden Evins

Director, Center for Addiction Medicine; Professor in Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eden Evins, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Other Identifiers

2020P000055

Identifier Type: -

Identifier Source: org_study_id