Clinical trial NCT04340700: Characterization of the Pharmacodynamic Response to Vaped THC
Official title: Characterization of the Pharmacodynamic Response to Vaped THC
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Vaping
THC
Keywords: Vaping
THC
fNIRS
Cannabis
Imaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change in Drug Effects Questionnaire
timeFrame: Pre-dose, and 15, 60, 90, 130, 165, 210 minutes post dose
measure: Change in Biphasic Alcohol Effects Scale (Modified for THC)
timeFrame: Pre-dose, and 15, 60, 90, 130, 165, 210 minutes post dose
measure: Change in The Spielberger State Anxiety Inventory
timeFrame: Pre-dose, and 15, 60, 90, 130, 165, 210 minutes post dose
measure: Change in Driving Simulation Performance on the Divided Attention Task (DAT)
timeFrame: Pre-dose, and 60 and 90 minutes post dose
Secondary outcomes:
measure: Change in Functional Near-Infrared Spectroscopy (fNIRS) Brain Signal
timeFrame: Pre-dose, and 30 and 180 minutes post dose
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Eden Evins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: