Status:
WITHDRAWN
Characterization of the Pharmacodynamic Response to Vaped THC
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Vaping
THC
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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, an...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04340700
Start Date
November 1 2022
End Date
October 1 2025
Last Update
February 11 2022
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