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

NCT ID: NCT07346690

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2028-02-01

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

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 Type EXPERIMENTAL

AVCN319301b (6mg)

Intervention Type DRUG

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

AVCN319301b (9mg)

Intervention Type DRUG

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

AVCN319301b (15mg)

Intervention Type DRUG

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

Placebo

Intervention Type 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: AVCN9mg -> AVCN15mg -> Placebo -> AVCN6mg

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 Type EXPERIMENTAL

AVCN319301b (6mg)

Intervention Type DRUG

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

AVCN319301b (9mg)

Intervention Type DRUG

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

AVCN319301b (15mg)

Intervention Type DRUG

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

Placebo

Intervention Type 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

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 Type EXPERIMENTAL

AVCN319301b (6mg)

Intervention Type DRUG

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

AVCN319301b (9mg)

Intervention Type DRUG

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

AVCN319301b (15mg)

Intervention Type DRUG

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

Placebo

Intervention Type 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: Placebo -> AVCN6mg -> AVCN9mg -> AVCN15mg

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 Type EXPERIMENTAL

AVCN319301b (6mg)

Intervention Type DRUG

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

AVCN319301b (9mg)

Intervention Type DRUG

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

AVCN319301b (15mg)

Intervention Type DRUG

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

Placebo

Intervention Type 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.

Interventions

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AVCN319301b (6mg)

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

Intervention Type DRUG

AVCN319301b (9mg)

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

Intervention Type DRUG

AVCN319301b (15mg)

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Low Dose Medium Dose High Dose

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Calgary, Heritage Medical Research Building

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Central Contacts

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Leah M Mayo, PhD

Role: CONTACT

587-893-0257

Facility Contacts

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Gavin N Petrie, PhD

Role: primary

5194009323

Other Identifiers

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DRATT

Identifier Type: -

Identifier Source: org_study_id

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