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

Disqualifiers: Bipolar, Psychosis, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different doses of THC, an active ingredient in cannabis, affect psychological and physical responses. Researchers will compare three levels of THC to a placebo to assess effects on mood and heart rate. Individuals who have used cannabis without major issues and are in good health might be suitable for this study. Participants will attend four sessions to receive either THC or a placebo and report their experiences. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that THC, the main ingredient in the investigational treatment AVCN319301b, has been studied in many situations. Past studies indicate that participants generally tolerate THC well, especially those with prior cannabis use. Most side effects are mild, such as dizziness or dry mouth, while serious side effects are rare.

In this trial, participants will take different doses of THC at various times to help manage any side effects. Researchers will monitor heart rate, blood pressure, and other vital signs to ensure safety. Additionally, using a placebo (a non-active look-alike) allows researchers to compare the real effects of THC to no treatment.

While any treatment can have side effects, previous studies suggest that THC is relatively safe for those familiar with cannabis. Researchers will closely monitor participants to ensure their safety and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about AVCN319301b because it uses a unique approach involving THC doses to potentially improve both psychological and biological functions. Unlike traditional treatments that may focus solely on psychological symptoms, AVCN319301b is exploring the synergistic effects of THC on the body and mind. This treatment stands out due to its varied dosing strategy, allowing researchers to observe effects at different concentrations, and its innovative crossover design, which helps ensure that results are comprehensive and reliable.

What evidence suggests that this trial's treatments could be effective?

Research has shown that THC, the main ingredient in cannabis, affects both mood and physical responses. Studies have found that varying amounts of THC change heart rate and blood pressure. Sometimes, THC links to changes in anxiety and mood. Early results suggest that higher amounts might have stronger effects on the body and mind. This trial will examine these effects by testing three different doses of the investigational treatment AVCN319301b, alongside a placebo. Understanding these reactions can help determine how THC might be used in medical treatments. ^{6 7}

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

I am between 18 and 55 years old.

I do not have any major medical or mental health conditions.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different doses of THC or placebo across four in-person visits, with physiological and subjective responses monitored

4 weeks

4 visits (in-person)

Washout

A washout period of more than 1 week between each dose to clear the previous dose from the system

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after the last dose

1 week

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+

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT07346690?aggFilters=status%3A%2Cphase%3A

A Study Testing the Effects of Different THC Doses ...

The goal of this clinical trial is to learn how a investigational medicinal product (THC) affects psychological and physical responses in ...

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Cardiac Nursing CEU - Free CEU Courses Online For Nurses

A Study Testing the Effects of Different THC Doses on Psychological and Biological Function. January 16, 2026. Conditions: Evaluate PK Profile; Evaluate PD ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07346690?term=physio+OR+physical+therapy+OR+exercise+therapy+OR+physiotherapy

A Study Testing the Effects of Different THC Doses ...

The goal of this clinical trial is to learn how a investigational medicinal product (THC) affects psychological and physical responses in ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06878417

Cannabinoids for Osteoarthritis Pain Effectiveness Trial

This study aims to investigate whether oral cannabis extracts can effectively manage pain caused by osteoarthritis (OA), a common joint condition affecting ...

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ir.avicanna.com/wp-content/uploads/2024/07/AVCN-18-July-2024.pdf

AVCN 18 July 2024

Patient education on product selection, dosing, and side effects. • Adverse reaction guidance and drug interactions check. • Patient ...

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medium.com/@paola_25068/cannabinoid-clinical-trial-in-canada-what-is-the-landscape-after-the-canada-act-b7a3c8cc5cc4

Cannabinoid clinical trials in Canada: the landscape after ...

Cannabinoid clinical trials in Canada: the landscape after the Canada Act Adult-use cannabis became legal in in Canada on October 17, 2018.

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