Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Study Drug: AVCN6mg -> AVCN9mg -> AVCN15mg -> Placebo | Experimental | 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. |
|
| Oral Study Drug: AVCN9mg -> AVCN15mg -> Placebo -> AVCN6mg | Experimental | 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. |
|
| Oral Study Drug: AVCN15mg -> Placebo -> AVCN6mg -> AVCN9mg | Experimental | 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. |
|
| Oral Study Drug: Placebo -> AVCN6mg -> AVCN9mg -> AVCN15mg | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVCN319301b (6mg) | Drug | AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and multiple points up to 300 minutes post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and multiple points up to 300 minutes post-dose. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leah M Mayo, PhD | Contact | 587-893-0257 | leah.mayo@ucalgary.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary, Heritage Medical Research Building | Calgary | Alberta | T2N 4N1 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| AVCN319301b (9mg) | Drug | AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC. |
|
|
| AVCN319301b (15mg) | Drug | AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC. |
|
|
| Placebo | 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. |
|
| 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 | 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. | 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. | 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. | 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. | Continuous measurements from baseline to 300 minutes post-dose. |
| Blood Pressure | Systolic and diastolic blood pressure are obtained with an automated cuff. | 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. | 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). | 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. | 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. | Blood samples collected at multiple points from baseline to 300 minutes post-dose. |
| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
Not provided
Not provided