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A Study of Ingested Cannabidiol in Healthy Occasional Cannabis Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05407285
Recruitment Status : Not yet recruiting
First Posted : June 7, 2022
Last Update Posted : June 7, 2022
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cannabis Drug: Cannabis, placebo Phase 1 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover Assignment In this crossover design, participants will be administered both dosages of CBD and placebo during participation in the study. Participant will be randomly assigned to one of ten pre-determined sequences with a CBD or placebo product at 5 dosages (0 mg, 20 mg, 50 mg, 100 mg and 200 mg). Participants will be randomized based on a completely balanced 5 by 5 latin square.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Triple-blind, Placebo-controlled, Randomized, Crossover Study of Low Dose Oral Synthetic Cannabidiol Effects in Healthy Cannabis Occasional Users
Estimated Study Start Date : July 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: CBD (Group 1)
Group will receive four CBD doses (20 mg, 50 mg, 100 mg, 200 mg), and placebo (0 mg). Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
Drug: Cannabis, placebo
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.

Experimental: CBD (Group 2)
Group will receive four CBD doses (20 mg, 50 mg, 100 mg, 200 mg), and placebo (0 mg). Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
Drug: Cannabis, placebo
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.

Experimental: CBD (Group 3)
Group will receive four CBD doses (20 mg, 50 mg, 100 mg, 200 mg), and placebo (0 mg). Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
Drug: Cannabis, placebo
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.

Experimental: CBD (Group 4)
Group will receive four CBD doses (20 mg, 50 mg, 100 mg, 200 mg), and placebo (0 mg). Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
Drug: Cannabis, placebo
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.

Experimental: CBD (Group 5)
Group will receive four CBD doses (20 mg, 50 mg, 100 mg, 200 mg), and placebo (0 mg). Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
Drug: Cannabis, placebo
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Safety [ 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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Between 21 and 65 years of age, inclusively;
  2. Occasional users, having used cannabis three days or less in the 28 days prior to enrollment;
  3. Be able to provide a signed informed consent;
  4. 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;
  5. Able to communicate and understand English or French language;
  6. 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:

  1. 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;
  2. Known chronic liver disease or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >ULN (upper limit of normal) at screening visit;
  3. Mean systolic blood pressure >180 mmHg (millimètre de mercure);
  4. Resting heart rate over 100 beats per minute (bpm);
  5. Current body mass index (BMI) of over 40;
  6. Must not have any clinically significant ECG abnormalities at screening visit;
  7. 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);
  8. 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;
  9. Current substance use disorder (except nicotine) according to SCID-V (Structured Clinical Interview for the DSM-5);
  10. Currently pregnant, breastfeeding or planning to become pregnant either at screening or while enrolled in the study;
  11. Pending legal action or other reason that, in the opinion of the study physician, might prevent study completion;
  12. Use of medication within 7 days of experimental sessions; which, in the opinion of the Investigator, may interact with CBD,
  13. Participation in clinical trials or undergoing other investigational procedure related to cannabis or cannabinoid administration within 30 days prior to randomization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05407285


Contacts
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Contact: Pamela Lachance-Touchette, Ph.D. 514-890-8000 ext 30938 pamela.lachance-touchette.chum@ssss.gouv.qc.ca
Contact: Didier Jutras-Aswad, MD,MS 514-890-8000 ext 35703 didier.jutras-aswad@umontreal.ca

Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Didier Jutras-Aswad, MD,MS Centre hospitalier de l'Université de Montréal (CHUM)
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT05407285    
Other Study ID Numbers: 22.049
First Posted: June 7, 2022    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders