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

NCT07346690 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-16

No results posted yet for this study

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

  • Evaluate PK Profile
  • Evaluate PD Profile
  • Healthy Adults
  • Safety and Tolerability in Healthy Volunteers

Interventions

DRUG

AVCN319301b (6mg)

AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.

DRUG

AVCN319301b (9mg)

AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.

DRUG

AVCN319301b (15mg)

AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.

DRUG

Placebo

The 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.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2028-02-01
Completion
2028-02-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07346690 on ClinicalTrials.gov