Skip to main content
OpenTrials
Completed

NCT Number: NCT05407285

A Study of Ingested Cannabidiol in Healthy Occasional Cannabis Users

The purposes of this study are 1) to determine if the administration of different low doses of oral CBD (20 mg, 50 mg, 100 mg and 200 mg) result in detectable subjective pleasant drug effect compared to placebo and 2) to qualitatively explore whether low dose of oral CBD is associated with effects that are not detected with the available research tools.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cannabis Chemically-Induced Disorders Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centre de recherche du Centre Hospitalier Universitaire de Montréal

Montreal, Quebec, H2X0A9, Canada

About this study

Cannabis contains over 100 cannabinoids, the two most prominent being Δ-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). A growing body of evidence exists surrounding the effects of both THC and CBD, however, less is known about the specific effects of CBD concentrations alone. Most existing data regarding the effects of CBD come from studies where this compound is administered in high doses in a therapeutic context, and where the subject can be administered either CBD, THC or both together. These contexts are not representative of the current use by many consumers. Indeed, several available products contain CBD at much lower doses. The overall objective of this study is to evaluate the acute behavioral and biological effects of low doses of ingested CBD (between 20-200mg) and placebo in occasional cannabis users. Potential outcomes not detected with usual assessment tools designed to evaluate THC-induced effects will also be explored.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between 21 and 65 years of age, inclusively;
  • Occasional users, having used cannabis three days or less in the 28 days prior to enrollment;
  • Be able to provide a signed informed consent;
  • Willing to comply with study procedures and requirements as per protocol, including to abstain from using other cannabis products or any drugs (except alcohol or nicotine) 7 days prior to study visits;
  • Able to communicate and understand English or French language;
  • For female participants:

a. Without childbearing potential, defined as: i. postmenopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age); or ii. Documented surgically sterilized (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or b. With childbearing potential: i. Must have negative pregnancy test result at screening and at subsequent visits.

ii. AND have no pregnancy plan while on the trial. iii. AND agree to use a medically accepted method of birth control throughout the study.

Exclusion criteria

  • Any disabling medical condition, as assessed by medical history, physical exam, vital signs and/or laboratory assessments that, in the opinion of the study physician, precludes safe participation in the study or the ability to provide fully informed consent;
  • Known chronic liver disease or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >ULN (Upper Limit of Normal) at screening visit;
  • Mean systolic blood pressure >180 mmHg (millimeter of mercury);
  • Resting heart rate over 100 beats per minute (bpm);
  • Current body mass index (BMI) of over 40;
  • Must not have any clinically significant ECG abnormalities at screening visit;
  • Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or bipolar disorder; current acute psychosis, mania or current suicidality based on the Mini International Neuropsychiatric Interview);
  • Any other disabling, unstable or acute mental condition that, in the opinion of the study physician, precludes safe participation in the study or ability to provide fully informed consent;
  • Current substance use disorder (except nicotine) according to Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders ( SCID-V);
  • Currently pregnant, breastfeeding or planning to become pregnant either at screening or while enrolled in the study;
  • Pending legal action or other reason that, in the opinion of the study physician, might prevent study completion;
  • Use of medication within 7 days of experimental sessions; which, in the opinion of the Investigator, may interact with CBD,
  • Participation in clinical trials or undergoing other investigational procedure related to cannabis or cannabinoid administration within 30 days prior to randomization.

Treatment and study plan

cannabis 0 mg, placebo

Drug

Eligible participant will be randomize 1:1:1:1:1 to receive study products in a prefilled single syringe with 2 ml of product solution with varying amounts of CBD (0 - 20 mg - 50 mg -100 mg - 200 mg. Only one research product will be ingested at each visit. The sequence will depend on the assigned randomization group.

Other names: CBD, placebo

Cannabis 20 mg,

Drug

Eligible participant will be randomize 1:1:1:1:1 to receive study products in a prefilled single syringe with 2 ml of product solution with varying amounts of CBD (0 - 20 mg - 50 mg -100 mg - 200 mg. Only one research product will be ingested at each visit. The sequence will depend on the assigned randomization group.

Other names: CBD

Cannabis 50 mg

Drug

Eligible participant will be randomize 1:1:1:1:1 to receive study products in a prefilled single syringe with 2 ml of product solution with varying amounts of CBD (0 - 20 mg - 50 mg -100 mg - 200 mg. Only one research product will be ingested at each visit. The sequence will depend on the assigned randomization group.

Other names: CBD

Cannabis 100 mg

Drug

Eligible participant will be randomize 1:1:1:1:1 to receive study products in a prefilled single syringe with 2 ml of product solution with varying amounts of CBD (0 - 20 mg - 50 mg -100 mg - 200 mg. Only one research product will be ingested at each visit. The sequence will depend on the assigned randomization group.

Other names: CBD

Cannabis 200 mg

Drug

Eligible participant will be randomize 1:1:1:1:1 to receive study products in a prefilled single syringe with 2 ml of product solution with varying amounts of CBD (0 - 20 mg - 50 mg -100 mg - 200 mg. Only one research product will be ingested at each visit. The sequence will depend on the assigned randomization group.

Other names: CBD

Primary outcomes

  1. Pleasant drug effect

    Time frame: T1 (60 minutes after ingestion)

    Pleasant drug effect will be assessed using a single item, visual analog scale, administered following administration of the study product at each study visit. It is rated on a continuous scale ranging from 0 (not at all) to 100 (extremely).

  2. Pleasant drug effect

    Time frame: T2 (120 minutes after ingestion)

    Pleasant drug effect will be assessed using a single item, visual analog scale, administered following administration of the study product at each study visit. It is rated on a continuous scale ranging from 0 (not at all) to 100 (extremely).

  3. Pleasant drug effect

    Time frame: T3 (210 minutes after ingestion)

    Pleasant drug effect will be assessed using a single item, visual analog scale, administered following administration of the study product at each study visit. It is rated on a continuous scale ranging from 0 (not at all) to 100 (extremely).

  4. Pleasant drug effect

    Time frame: T4 (300 minutes after ingestion)

    Pleasant drug effect will be assessed using a single item, visual analog scale, administered following administration of the study product at each study visit. It is rated on a continuous scale ranging from 0 (not at all) to 100 (extremely).

  5. Pleasant drug effect

    Time frame: T5 (360 minutes after ingestion)

    Pleasant drug effect will be assessed using a single item, visual analog scale, administered following administration of the study product at each study visit. It is rated on a continuous scale ranging from 0 (not at all) to 100 (extremely).

Secondary outcomes

  1. Drug Effects associated with cannabis ingestion

    Time frame: T1 (60 minutes after ingestion)

    Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis ingestion and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).

  2. Drug Effects associated with cannabis ingestion

    Time frame: T2 (120 minutes after ingestion)

    Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis ingestion and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).

  3. Drug Effects associated with cannabis ingestion

    Time frame: T3 (210 minutes after ingestion)

    Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis ingestion and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).

  4. Drug Effects associated with cannabis ingestion

    Time frame: T4 (300 minutes after ingestion)

    Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis ingestion and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).

  5. Drug Effects associated with cannabis ingestion

    Time frame: T5 (360 minutes after ingestion)

    Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis ingestion and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).

  6. Change in dissociation

    Time frame: Baseline and after ingestion at (120 minutes, 300 minutes)

    Dissociation will be assessed using the Clinician Administered Dissociative States Scale administered at Baseline (T0) and following administration of the study product (T2- 120 minutes, T4-300 minutes) at each study visit. The Clinician Administered Dissociative States Scale, a 28-items validated instrument, includes 5 observer items and 23 participant self-report items rated on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). Minimum score :0 not at all; Maximum score 92 extremely dissociate

  7. Cannabis-Specific Subjective Effects

    Time frame: T5 (360 minutes after ingestion)

    Subjective effects of cannabis will be assessed using both the positive and negative subscales of the Cannabis Experience Questionnaire administered following administration study product. Each item is rated on a 5-point scale, ranging from 1 (not at all) to 5 (severely).The positive subscale includes16 items related to euphoric experiences (maximum 90 and minimum 16). The negative subscale includes 25 items related to paranoid-dysphoric experiences (Maximum 125 and minimum 25).

  8. Change in Affect

    Time frame: Baseline and after ingestion at (120 minutes, 300 minutes)

    Affect will be measured using the Positive and Negative Affect Schedule administered at Baseline (T0) and following administration of the study product at each study visit. The Positive and Negative Affect Schedule is a 20-item validated questionnaire divided into subscales of positive (10 items) and negative affect (10 items). Each item is rated on a 5-point scale ranging from 1 (not at all) to 5 (extremely). For each subscale minimum is 10 and maximum 50.

  9. Change in Anxiety Symptoms

    Time frame: Baseline and after ingestion at (120 minutes, 300 minutes)

    Symptoms of anxiety will be assessed using the States-Trait-Anxiety-Inventory, a 20-item validated self-report scale that measures the severity of anxiety in adults. Each symptom is rated on a 4-point scale ranging from 1 (not at all) to 4 (very much).

  10. Change in the incidence of Treatment Emergent-adverse Events

    Time frame: Baseline and after ingestion at (60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)

    Adverse events will be collected prior to administration of the study product (T0) and following administration of the study product (T1, T2, T3,T4, T5)

  11. Change on cognition

    Time frame: Baseline and after ingestion at 210 minutes

    The Cambridge Neuropsychological Test Automated Battery tests will be used for the rapid assessment of multiple cognitive components.

  12. Visit Intoxication Assessment

    Time frame: End of the visit, approximatively 360 minutes after ingestion

    Signs of intoxication will be assess using the modified Standardized Field Sobriety Test.

Other outcomes

  1. Change in plasma concentration of CBD

    Time frame: Baseline and after ingestion at ( 60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)

    Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after ingestion.

  2. Change in plasma concentration of 7-Hydroxy-cannabidiol

    Time frame: Baseline and after ingestion at ( 60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)

    Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after ingestion.

  3. Change in plasma concentration of 7-Carboxy-Cannabidiol

    Time frame: Baseline and after ingestion at ( 60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)

    Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after ingestion.

  4. Change in plasma concentration of Anandamide

    Time frame: Baseline and after ingestion at ( 60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)

    Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after ingestion.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

A Triple-blind, Placebo-controlled, Randomized, Crossover Study of Low Dose Oral Synthetic Cannabidiol Effects in Healthy Cannabis Occasional Users

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 7, 2022
Registry last updated
Apr 22, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.