Evaluate PK ProfilePhase 1DRATTNCT07346690
A Study Testing the Effects of Different THC Doses on Psychological and Biological Function
A Phase 1 study testing AVCN319301b (6mg), AVCN319301b (9mg) and AVCN319301b (15mg) in people with Evaluate PK Profile and Evaluate PD Profile, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluate PK Profile, Evaluate PD Profile, Healthy Adults
- What is being tested?
- AVCN319301b (6mg), AVCN319301b (9mg) and AVCN319301b (15mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2026to 1 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-55
- No major medical or psychiatric conditions
- At least one previous, well-tolerated experience with cannabis
- Not currently pregnant or breastfeeding
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of Calgary, Heritage Medical Research Building
Calgary, Alberta, T2N 4N1
Gavin N Petrie, PhD, 5194009323, gavin.petrie@ucalgary.ca
About this study
Official title: Acute Dose-Dependent Effects of Oral THC on Physiological and Subjective Responses in Healthy Cannabis-Experienced Adults
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?
Read more
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
- Conditions
- Evaluate PK Profile, Evaluate PD Profile, Healthy Adults, Safety and Tolerability in Healthy Volunteers
- Being tested
- AVCN319301b (6mg), AVCN319301b (9mg), AVCN319301b (15mg), Placebo
- Keywords
- Cannabinoid, Cannabis
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVCN319301b (6mg)Drug
Also called Low Dose
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
AVCN319301b (9mg)Drug
Also called Medium Dose
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
AVCN319301b (15mg)Drug
Also called High Dose
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: AVCN319301b (6mg); Drug: AVCN319301b (9mg); Drug: AVCN319301b (15mg); Drug: Placebo |
| 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. Receives: Drug: AVCN319301b (6mg); Drug: AVCN319301b (9mg); Drug: AVCN319301b (15mg); Drug: Placebo |
| 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. Receives: Drug: AVCN319301b (6mg); Drug: AVCN319301b (9mg); Drug: AVCN319301b (15mg); Drug: Placebo |
| 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. Receives: Drug: AVCN319301b (6mg); Drug: AVCN319301b (9mg); Drug: AVCN319301b (15mg); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and multiple points up to 300 minutes post-dose.
Secondary outcomes (11)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Continuous measurements from baseline to 300 minutes post-dose.
Blood Pressure
Systolic and diastolic blood pressure are obtained with an automated cuff.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Blood samples collected at multiple points from baseline to 300 minutes post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate PK ProfileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346690
- Sponsor's protocol ID
- DRATT
- Acronym
- DRATT
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Dose-Dependent Effects of Oral THC on Physiological and Subjective Responses in Healthy Cannabis-Experienced Adults
- ClinicalTrials.gov ID
- NCT07346690
- Acronym / sponsor ID
- DRATT / DRATT
- Conditions
- Evaluate PK Profile, Evaluate PD Profile, Healthy Adults, Safety and Tolerability in Healthy Volunteers
- Keywords
- Cannabinoid, Cannabis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral Study Drug: AVCN6mg -> AVCN9mg -> AVCN15mg -> Placebo | Experimental | Drug: AVCN319301b (6mg), Drug: AVCN319301b (9mg), Drug: AVCN319301b (15mg), Drug: Placebo3 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 | Drug: AVCN319301b (6mg), Drug: AVCN319301b (9mg), Drug: AVCN319301b (15mg), Drug: Placebo3 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 | Drug: AVCN319301b (6mg), Drug: AVCN319301b (9mg), Drug: AVCN319301b (15mg), Drug: Placebo3 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 | Drug: AVCN319301b (6mg), Drug: AVCN319301b (9mg), Drug: AVCN319301b (15mg), Drug: Placebo3 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18-55
- No major medical or psychiatric conditions
- At least one previous, well-tolerated experience with cannabis
- Not currently pregnant or breastfeeding
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVCN319301b (6mg)Also: Low DoseAVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC. | Drug | Oral Study Drug: AVCN15mg -> Placebo -> AVCN6mg -> AVCN9mg, Oral Study Drug: AVCN6mg -> AVCN9mg -> AVCN15mg -> Placebo, Oral Study Drug: AVCN9mg -> AVCN15mg -> Placebo -> AVCN6mg, Oral Study Drug: Placebo -> AVCN6mg -> AVCN9mg -> AVCN15mg |
| AVCN319301b (9mg)Also: Medium DoseAVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC. | Drug | Oral Study Drug: AVCN15mg -> Placebo -> AVCN6mg -> AVCN9mg, Oral Study Drug: AVCN6mg -> AVCN9mg -> AVCN15mg -> Placebo, Oral Study Drug: AVCN9mg -> AVCN15mg -> Placebo -> AVCN6mg, Oral Study Drug: Placebo -> AVCN6mg -> AVCN9mg -> AVCN15mg |
| AVCN319301b (15mg)Also: High DoseAVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC. | Drug | Oral Study Drug: AVCN15mg -> Placebo -> AVCN6mg -> AVCN9mg, Oral Study Drug: AVCN6mg -> AVCN9mg -> AVCN15mg -> Placebo, Oral Study Drug: AVCN9mg -> AVCN15mg -> Placebo -> AVCN6mg, Oral Study Drug: Placebo -> AVCN6mg -> AVCN9mg -> AVCN15mg |
| PlaceboThe 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. | Drug | Oral Study Drug: AVCN15mg -> Placebo -> AVCN6mg -> AVCN9mg, Oral Study Drug: AVCN6mg -> AVCN9mg -> AVCN15mg -> Placebo, Oral Study Drug: AVCN9mg -> AVCN15mg -> Placebo -> AVCN6mg, Oral Study Drug: Placebo -> AVCN6mg -> AVCN9mg -> AVCN15mg |
Primary outcome
State Trait Anxiety Inventory - State
Time frame: 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.
11 secondary outcomes
Subjective Drug Effects (Drug Effects Questionnaire; DEQ)
Time frame: Baseline and multiple points up to 300 minutes post-dose.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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)
Time frame: Baseline and multiple points up to 300 minutes post-dose.
Positive and Negative Affect (PANAS-SF)
Time frame: Baseline and multiple points up to 300 minutes post-dose.
Heart Rate
Time frame: Continuous measurements from baseline to 300 minutes post-dose.
Heart Rate Variability
Time frame: Continuous measurements from baseline to 300 minutes post-dose.
Blood Pressure
Time frame: Continuous measurements from baseline to 300 minutes post-dose.
Cortisol Levels
Time frame: Blood samples collected at multiple points from baseline to 300 minutes post-dose.
Endocannabinoid Levels
Time frame: Blood samples collected at multiple points from baseline to 300 minutes post-dose.
Cmax of Δ9-THC and its Metabolites
Time frame: Blood samples collected at multiple points from baseline to 300 minutes post-dose.
Tmax of Δ9-THC and its Metabolites
Time frame: Blood samples collected at multiple points from baseline to 300 minutes post-dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVCN319301b (6mg), AVCN319301b (9mg) and AVCN319301b (15mg) in people with Evaluate PK Profile and Evaluate PD Profile, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leah M Mayo, PhD (587-893-0257, leah.mayo@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Trait Anxiety Inventory - State (time frame: Baseline and multiple points up to 300 minutes post-dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.