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
Adults aged 18-55
No major medical or psychiatric conditions
At least one previous, well-tolerated experience with cannabis
Not currently pregnant or breastfeeding
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
Crossover
AVCN319301b (6mg)
DrugAVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
AVCN319301b (9mg)
DrugAVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
AVCN319301b (15mg)
DrugAVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
Placebo
DrugThe 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.
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.
Subjective Drug Effects (Drug Effects Questionnaire; DEQ)
The DEQ is a brief self-report scale assessing immediate subjective reactions to the study drug. Participants rate sensations such as "feel drug effects," "feel high," or "like the drug" on visual analog scales. This measure captures moment-to-moment changes in subjective experience across the session.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
All adverse events reported by participants or observed by study staff are recorded and categorized by severity and relatedness to the investigational medicinal product
Mood States (Profile of Mood States; POMS)
The POMS measures transient emotional states such as tension, calmness, fatigue, and well-being. Participants rate how they feel using a list of adjectives. Scores reflect current mood and allow researchers to track short-lived emotional changes across the study period.
Positive and Negative Affect (PANAS-SF)
The PANAS-SF asks participants to rate the extent to which they feel various positive and negative emotions. Scores give a snapshot of emotional tone during the session.
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