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

NCT07346690 | Not Yet Recruiting Phase 1

• 1 other identifier: DRATT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cannabinoid; Cannabis

Outcome Measures

Primary Outcomes (1)

• State Trait Anxiety Inventory - State

  The STAI-S is a validated self-report questionnaire that measures how anxious or calm a person feels "right now." Participants rate statements about current stress, worry, or relaxation on a 4-point scale. Scores are summed to provide a total anxiety rating. Higher scores reflect greater momentary anxiety. This measure is repeated throughout each session to track short-term changes in emotional state following study drug or placebo.

  Baseline and multiple points up to 300 minutes post-dose.

Secondary Outcomes (11)

• Subjective Drug Effects (Drug Effects Questionnaire; DEQ)

  Baseline and multiple points up to 300 minutes post-dose.

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Adverse event recording begins with receiving the first dose of investigational medicinal product and ends one week following the last dose of investigational medicinal product (end of study).

• Mood States (Profile of Mood States; POMS)

  Baseline and multiple points up to 300 minutes post-dose.

• Positive and Negative Affect (PANAS-SF)

  Baseline and multiple points up to 300 minutes post-dose.

• Heart Rate

  Continuous measurements from baseline to 300 minutes post-dose.

Study Arms (4)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

Interventions

AVCN319301b (9mg) DRUG

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

Also known as: Medium Dose

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

AVCN319301b (15mg) DRUG

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

Also known as: High Dose

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

Placebo DRUG

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.

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

AVCN319301b (6mg) DRUG

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

Also known as: Low Dose

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary, Heritage Medical Research Building

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Contraceptives, Oral

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Central Study Contacts

Leah M Mayo, PhD

CONTACT

587-893-0257; leah.mayo@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 16, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2025-12

Locations

CA (1)