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

January 7, 2026 updated by: University of Calgary

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?

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary, Heritage Medical Research Building
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 18-55
  • No major medical or psychiatric conditions
  • At least one previous, well-tolerated experience with cannabis
  • Not currently pregnant or breastfeeding

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Study Drug: AVCN6mg -> AVCN9mg -> AVCN15mg -> 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)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
Other Names:
  • Low Dose
Drug: AVCN319301b (9mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
Other Names:
  • Medium Dose
Drug: AVCN319301b (15mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
Other Names:
  • High Dose
Drug: 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.
Experimental: Oral Study Drug: AVCN9mg -> AVCN15mg -> Placebo -> AVCN6mg
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)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
Other Names:
  • Low Dose
Drug: AVCN319301b (9mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
Other Names:
  • Medium Dose
Drug: AVCN319301b (15mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
Other Names:
  • High Dose
Drug: 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.
Experimental: Oral Study Drug: AVCN15mg -> Placebo -> AVCN6mg -> AVCN9mg
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)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
Other Names:
  • Low Dose
Drug: AVCN319301b (9mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
Other Names:
  • Medium Dose
Drug: AVCN319301b (15mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
Other Names:
  • High Dose
Drug: 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.
Experimental: Oral Study Drug: Placebo -> AVCN6mg -> AVCN9mg -> AVCN15mg
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)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
Other Names:
  • Low Dose
Drug: AVCN319301b (9mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
Other Names:
  • Medium Dose
Drug: AVCN319301b (15mg)
AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
Other Names:
  • High Dose
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and multiple points up to 300 minutes post-dose.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Drug Effects (Drug Effects Questionnaire; DEQ)
Time Frame: Baseline and multiple points up to 300 minutes post-dose.
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.
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).
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)
Time Frame: Baseline and multiple points up to 300 minutes post-dose.
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)
Time Frame: Baseline and multiple points up to 300 minutes post-dose.
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
Time Frame: Continuous measurements from baseline to 300 minutes post-dose.
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
Time Frame: Continuous measurements from baseline to 300 minutes post-dose.

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
Time Frame: Continuous measurements from baseline to 300 minutes post-dose.
Systolic and diastolic blood pressure are obtained with an automated cuff.
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.
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
Time Frame: Blood samples collected at multiple points from baseline to 300 minutes post-dose.
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
Time Frame: Blood samples collected at multiple points from baseline to 300 minutes post-dose.
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
Time Frame: Blood samples collected at multiple points from baseline to 300 minutes post-dose.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRATT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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