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

University of Calgary

Status and phase: Not yet enrolling; Phase 1

Conditions: Safety and Tolerability in Healthy Volunteers; Evaluate PD Profile; Healthy Adults; Evaluate PK Profile

Treatments: Drug: AVCN319301b (15mg); Drug: Placebo; Drug: AVCN319301b (9mg); Drug: AVCN319301b (6mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT07346690

DRATT

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged 18-55
• No major medical or psychiatric conditions
• At least one previous, well-tolerated experience with cannabis
• Not currently pregnant or breastfeeding

Exclusion criteria

• Family history (first- or second-degree relatives) of bipolar disorder, psychosis, or schizophrenia
• Significant negative reaction to cannabis in the past or known allergy to cannabis products
• Currently using recreational drugs

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 4 patient groups

Oral Study Drug: AVCN6mg -> AVCN9mg -> AVCN15mg -> Placebo

Experimental group

Description:

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.

Treatment:

Drug: AVCN319301b (6mg)

Drug: AVCN319301b (9mg)

Drug: Placebo

Drug: AVCN319301b (15mg)

Oral Study Drug: AVCN9mg -> AVCN15mg -> Placebo -> AVCN6mg

Experimental group

Description:

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.

Treatment:

Drug: AVCN319301b (6mg)

Drug: AVCN319301b (9mg)

Drug: Placebo

Drug: AVCN319301b (15mg)

Oral Study Drug: AVCN15mg -> Placebo -> AVCN6mg -> AVCN9mg

Experimental group

Description:

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.

Treatment:

Drug: AVCN319301b (6mg)

Drug: AVCN319301b (9mg)

Drug: Placebo

Drug: AVCN319301b (15mg)

Oral Study Drug: Placebo -> AVCN6mg -> AVCN9mg -> AVCN15mg

Experimental group

Description:

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.

Treatment:

Drug: AVCN319301b (6mg)

Drug: AVCN319301b (9mg)

Drug: Placebo

Drug: AVCN319301b (15mg)