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Not yet recruiting NCT07346690

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

Phase I Interventional Evaluate PK Profile Evaluate PD Profile Healthy Adults Safety and Tolerability in Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AVCN319301b (6mg), AVCN319301b (9mg), AVCN319301b (15mg), Placebo.
Who it may be relevant to
Registry conditions: Evaluate PK Profile, Evaluate PD Profile, Healthy Adults, Safety and Tolerability in Healthy Volunteers. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Drug AVCN319301b (6mg)
    AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
  • Drug AVCN319301b (9mg)
    AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
  • Drug AVCN319301b (15mg)
    AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.
  • 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.

Primary outcome measures

  • State Trait Anxiety Inventory - State [Time frame: Baseline and multiple points up to 300 minutes post-dose.]
Secondary outcome measures (11)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

Canada · 1 center
  • University of Calgary, Heritage Medical Research Building — Calgary

Identifiers

NCT: NCT07346690 · DRATT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗