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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Eligibility

Primary outcome measure(s)

• State Trait Anxiety Inventory - State — Baseline and multiple points up to 300 minutes post-dose.
  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.

Trial sites (1)

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