THC Doses for Psychological and Biological Function

(DRATT Trial)

Overseen By Leah M Mayo, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Calgary

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for healthy adults who have used cannabis before. Participants will need to attend four study visits and be comfortable with questionnaires, heart rate monitoring, blood pressure checks, and giving blood samples. Specific eligibility details are not provided.

Inclusion Criteria

* Adults aged 18-55

* No major medical or psychiatric conditions

* At least one previous, well-tolerated experience with cannabis

What Are the Treatments Tested in This Trial?

Interventions

• AVCN319301b

Trial Overview

The study tests how different doses of a THC-based drug (6mg, 9mg, or 15mg) affect psychological and physical responses compared to a placebo. It involves single-dose sessions with monitoring of subjective experiences and physiological measures.

How Is the Trial Designed?

Group I: Oral Study Drug: Placebo -> AVCN6mg -> AVCN9mg -> AVCN15mg Experimental Treatment 4 Interventions

3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by \>1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.

Group II: Oral Study Drug: AVCN9mg -> AVCN15mg -> Placebo -> AVCN6mg Experimental Treatment 4 Interventions

3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by \>1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.

Group III: Oral Study Drug: AVCN6mg -> AVCN9mg -> AVCN15mg -> Placebo Experimental Treatment 4 Interventions

3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by \>1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.

Group IV: Oral Study Drug: AVCN15mg -> Placebo -> AVCN6mg -> AVCN9mg Experimental Treatment 4 Interventions

3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by \>1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+