A Phase 1 interventional study of AVCN319301b (6mg) and AVCN319301b (9mg) in Evaluate PK Profile, Evaluate PD Profile and Healthy Adults, sponsored by University of Calgary. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by University of Calgary · Phase 1, Interventional, and Basic science
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:
517 studies on the registry are indexed under Marijuana Abuse; 114 are open to participants now.
This study's planned enrollment of 24 is below the median of 60 across 421 interventional studies indexed under Marijuana Abuse.
Browse Marijuana Abuse studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
Also known as: Low Dose
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
Also known as: Medium Dose
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
Also known as: High Dose
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.
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.
Time frame: Baseline and multiple points up to 300 minutes post-dose.
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.
Time frame: Baseline and multiple points up to 300 minutes post-dose.
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
Time frame: 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)
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.
Time frame: Baseline and multiple points up to 300 minutes post-dose.
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.
Time frame: Baseline and multiple points up to 300 minutes post-dose.
Heart Rate
Heart rate is measured using an automated vital-signs monitor while the participant is seated.
Time frame: Continuous measurements from baseline to 300 minutes post-dose.
Heart Rate Variability
Heart Rate Variability represents natural variation in the time between heartbeats and is calculated from continuous pulse or ECG-based data. \- Systolic and diastolic blood pressure are obtained with an automated cuff.
Time frame: Continuous measurements from baseline to 300 minutes post-dose.
Blood Pressure
Systolic and diastolic blood pressure are obtained with an automated cuff.
Time frame: Continuous measurements from baseline to 300 minutes post-dose.
Cortisol Levels
Cortisol is a hormone released during stress. Plasma cortisol concentrations are measured from venous blood samples using laboratory assays.
Time frame: Blood samples collected at multiple points from baseline to 300 minutes post-dose.
Endocannabinoid Levels
Endocannabinoids (AEA, 2-AG, PEA, OEA) and related lipids are naturally occurring signaling molecules. Plasma endocannabinoids are measured from venous blood samples using specialized laboratory techniques (e.g., LC-MS/MS).
Time frame: Blood samples collected at multiple points from baseline to 300 minutes post-dose.
Cmax of Δ9-THC and its Metabolites
Plasma Δ9-THC and its Metabolites (THC, 11-OH-THC, THC-COOH) are measured from venous blood samples using specialized laboratory techniques (e.g., LC-MS/MS) to calculate Cmax.
Time frame: Blood samples collected at multiple points from baseline to 300 minutes post-dose.
Tmax of Δ9-THC and its Metabolites
Plasma Δ9-THC and its Metabolites (THC, 11-OH-THC, THC-COOH) are measured from venous blood samples using specialized laboratory techniques (e.g., LC-MS/MS) to calculate Tmax.
Time frame: Blood samples collected at multiple points from baseline to 300 minutes post-dose.
Plan to share: Undecided
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University of Calgary