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Not Yet RecruitingNCT07346690

A Study Testing the Effects of Different THC Doses on Psychological and Biological Function

Acute Dose-Dependent Effects of Oral THC on Physiological and Subjective Responses in Healthy Cannabis-Experienced Adults

Status
Not Yet Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
24 (estimated)
Sponsor
University of Calgary · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

The goal of this clinical trial is to learn how a investigational medicinal product (THC) affects psychological and physical responses in healthy adults with prior cannabis use experience. The main questions it aims to answer are: \- How do different dose levels of the investigational medicinal product (THC) influence short-term subjective and physiological responses? Researchers will compare three dose levels of the study drug to a placebo (a look-alike substance with no active ingredient) to see how responses vary across sessions. Participants will: * Attend four in-person study visits, each involving a single dose of either the study drug or placebo * Complete questionnaires about their moment-to-moment experiences * Have their heart rate, blood pressure, and other physical measures monitored * Undergo serial blood sampling to measure circulating biomarkers

Conditions

Interventions

TypeNameDescription
DRUGAVCN319301b (6mg)AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
DRUGAVCN319301b (9mg)AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
DRUGAVCN319301b (15mg)AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
DRUGPlaceboThe matched placebo is an oral capsule identical in appearance to the active study drug and contains the same non-medicinal ingredients but no Δ9-THC. It is manufactured to match the active capsules in size, color, taste, and packaging to maintain blinding for participants and study staff.

Timeline

Start date
2026-02-01
Primary completion
2028-02-01
Completion
2028-02-01
First posted
2026-01-16
Last updated
2026-01-16

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT07346690. Inclusion in this directory is not an endorsement.