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NCT Number: NCT07346690

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

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

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Key information

Conditions

Evaluate PK Profile Chemically-Induced Disorders Evaluate PD Profile Healthy Adults Marijuana Abuse Mental Disorders Safety and Tolerability in Healthy Volunteers Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Calgary, Heritage Medical Research Building

Calgary, Alberta, T2N 4N1, Canada

Location contact

Gavin N Petrie, PhD

CONTACT

[email protected]

5194009323

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVCN319301b (6mg)

Drug

AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.

Other names: Low Dose

AVCN319301b (9mg)

Drug

AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.

Other names: Medium Dose

AVCN319301b (15mg)

Drug

AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.

Other names: High Dose

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Blood Pressure

    Time frame: Continuous measurements from baseline to 300 minutes post-dose.

    Systolic and diastolic blood pressure are obtained with an automated cuff.

  8. 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.

  9. 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).

  10. 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.

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Leah M Mayo, PhD

CONTACT

[email protected]

587-893-0257

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

Acute Dose-Dependent Effects of Oral THC on Physiological and Subjective Responses in Healthy Cannabis-Experienced Adults

Acronym: DRATT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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