A Study Testing the Effects of Different THC Doses on Psychological and Biological Function
NCT ID: NCT07346690
Last Updated: 2026-01-16
Study Results
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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NOT_YET_RECRUITING
PHASE1
24 participants
INTERVENTIONAL
2026-02-01
2028-02-01
Brief Summary
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\- 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
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.
AVCN319301b (6mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
AVCN319301b (9mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
AVCN319301b (15mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
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.
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.
AVCN319301b (6mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
AVCN319301b (9mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
AVCN319301b (15mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
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.
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.
AVCN319301b (6mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
AVCN319301b (9mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
AVCN319301b (15mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
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.
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.
AVCN319301b (6mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
AVCN319301b (9mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
AVCN319301b (15mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
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.
Interventions
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AVCN319301b (6mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
AVCN319301b (9mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
AVCN319301b (15mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No major medical or psychiatric conditions
* At least one previous, well-tolerated experience with cannabis
* Not currently pregnant or breastfeeding
Exclusion Criteria
* Significant negative reaction to cannabis in the past or known allergy to cannabis products
* Currently using recreational drugs
18 Years
55 Years
ALL
Yes
Sponsors
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University of Calgary
OTHER
Responsible Party
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Locations
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University of Calgary, Heritage Medical Research Building
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DRATT
Identifier Type: -
Identifier Source: org_study_id
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