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A Study of Inhaled 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: NCT05320367
Recruitment Status : Not yet recruiting
First Posted : April 11, 2022
Last Update Posted : November 15, 2022
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Tracking Information
First Submitted Date  ICMJE March 20, 2022
First Posted Date  ICMJE April 11, 2022
Last Update Posted Date November 15, 2022
Estimated Study Start Date  ICMJE April 2023
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2022)
  • Pleasant drug effect [ Time Frame: T1(10 minutes after inhalation) ]
    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).
  • Pleasant drug effect [ Time Frame: T2 (60 minutes after inhalation) ]
    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).
  • Pleasant drug effect [ Time Frame: T3 (120 minutes after inhalation) ]
    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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2022)
  • Drug Effects associated with cannabis administration [ Time Frame: T1 (10 minutes after inhalation) ]
    Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis administration and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
  • Drug Effects associated with cannabis administration [ Time Frame: T2 (60 minutes after inhalation) ]
    Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis administration and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
  • Drug Effects associated with cannabis administration [ Time Frame: T3 (120 minutes after inhalation) ]
    Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis administration and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
  • Change in dissociation [ Time Frame: Baseline and after inhalation at (10 minutes, 60 minutes) ]
    Dissociation will be assessed using the Clinician Administered Dissociative States Scale (CADSS) administered at Baseline (T0) and following administration of the study product (T1- 10 minutes, T2-60 minutes) at each study visit. The CADSS, 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 72 extremely dissociate.
  • Cannabis-Specific Subjective Effects [ Time Frame: T3 (120 minutes after inhalation) ]
    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).
  • Change in Affect [ Time Frame: Baseline and after inhalation at (10 minutes, 60 minutes, 120 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.
  • Change in Anxiety Symptoms [ Time Frame: Baseline and after inhalation at (10 minutes, 60 minutes and 120 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).
  • Change in Safety [ Time Frame: Baseline and after inhalation at (10 minutes, 60 minutes, 120 minutes) ]
    Adverse events will be collected prior to administration of the study product (T0) and following administration of the study product (T1, T2 and T3)
  • Change on cognition [ Time Frame: Baseline and after inhalation at T2 (60 minutes). ]
    The Cambridge Neuropsychological Test Automated Battery tests will be used for the rapid assessment of multiple cognitive components.
  • Visit Intoxication Assessment [ Time Frame: End of the visit, approximatively 180 minutes after inhalation ]
    Signs of intoxication will be assess using the modified Standardized Field Sobriety Test.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2022)
  • Drug Effectss associated with cannabis admistration [ Time Frame: T1 (10 minutes after inhalation) ]
    Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis administration and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
  • Drug Effects associated with cannabis admistration [ Time Frame: T2 (60 minutes after inhalation) ]
    Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis administration and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
  • Drug Effects associated with cannabis admistration [ Time Frame: T3 (120 minutes after inhalation) ]
    Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis administration and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
  • Change in dissociation [ Time Frame: Baseline and after inhalation at (10 minutes, 60 minutes) ]
    Dissociation will be assessed using the Clinician Administered Dissociative States Scale (CADSS) administered at Baseline (T0) and following administration of the study product (T1- 10 minutes, T2-60 minutes) at each study visit. The CADSS, 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 72 extremely dissociate.
  • Cannabis-Specific Subjective Effects [ Time Frame: T3 (120 minutes after inhalation) ]
    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).
  • Change in Affect [ Time Frame: Baseline and after inhalation at (10 minutes, 60 minutes, 120 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.
  • Change in Anxiety Symptoms [ Time Frame: Baseline and after inhalation at (10 minutes, 60 minutes and 120 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).
  • Change in Safety [ Time Frame: Baseline and after inhalation at (10 minutes, 60 minutes, 120 minutes) ]
    Adverse events will be collected prior to administration of the study product (T0) and following administration of the study product (T1, T2 and T3)
  • Change on cognition [ Time Frame: Baseline and after inhalation at T2 (60 minutes). ]
    The Cambridge Neuropsychological Test Automated Battery tests will be used for the rapid assessment of multiple cognitive components.
  • Visit Intoxication Assessment [ Time Frame: End of the visit, aproximatively 180 minutes after inhalation ]
    Signs of intoxication will be assess using the modified Standardized Field Sobriety Test.
Current Other Pre-specified Outcome Measures
 (submitted: April 1, 2022)
  • Change in plasma concentration of CBD [ Time Frame: Baseline and after inhalation at ( 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes) ]
    Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after inhalation.
  • Change in plasma concentration of 7-Hydroxycannabidiol [ Time Frame: Baseline and after inhalation at ( 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes) ]
    Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after inhalation.
  • Change in plasma concentration of 7-Carboxy-Cannabidiol [ Time Frame: Baseline and after inhalation at ( 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes) ]
    Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after inhalation.
  • Change in plasma concentration of Anandamide [ Time Frame: Baseline and after inhalation at ( 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes) ]
    Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after inhalation.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study of Inhaled Cannabidiol in Healthy Occasional Cannabis Users
Official Title  ICMJE A Randomized, Triple Blinded Cross-over Placebo Controlled Study of Effects of Inhaled Cannabidiol in Healthy Occasional Cannabis Users
Brief Summary The purposes of this study are 1) to determine if the administration of different low doses of CBD (5 mg, 17 mg, 50 mg and 100 mg) result in detectable subjective pleasant drug effect compared to placebo and 2) to qualitatively explore whether low dose CBD is associated with effects that are not detected with the available research tools.
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 CBD (between 5-100mg) and placebo in occasional cannabis users. Potential outcomes not detected with usual assessment tools designed to evaluate THC-induced effects will also be explored.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
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, 5 mg, 17 mg, 50 mg and 100 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
Condition  ICMJE Cannabis
Intervention  ICMJE Drug: Cannabis, placebo
Eligible participant will be randomize 1:1:1:1:1 to receive placebo, CBD (5mg, 17mg, 50mg and 100mg). Only one research product will be inhaled for each visit. The sequence will depend on the assigned randomization group.
Study Arms  ICMJE
  • Experimental: CBD (Group 1)

    Group will receive four CBD doses (5 mg, 17 mg, 50 mg and 100 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

    Intervention: Drug: Cannabis, placebo
  • Experimental: CBD (Group 2)

    Group will receive four CBD doses (5 mg, 17 mg, 50 mg and 100 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

    Intervention: Drug: Cannabis, placebo
  • Experimental: CBD (Group 3)

    Group will receive four CBD doses (5 mg, 17 mg, 50 mg and 100 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.

    Intervention: Drug: Cannabis, placebo
  • Experimental: CBD (Group 4)

    Group will receive four CBD doses (5 mg, 17 mg, 50 mg and 100 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.

    Intervention: Drug: Cannabis, placebo
  • Experimental: CBD (Group 5)

    Group will receive four CBD doses (5 mg, 17 mg, 50 mg and 100 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.

    Intervention: Drug: Cannabis, placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2022)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Between 21 and 65 years of age, inclusively;
  2. Have used cannabis at least once in lifetime AND have 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;
  5. Have a forced expiratory volume in first second (FEV) sup 90 %;
  6. Able to communicate and understand English or French language;
  7. 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 must 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. 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);
  3. 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;
  4. Current substance use disorder (except nicotine) according to Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-V );
  5. Currently pregnant, breastfeeding or planning to become pregnant either at screening or while enrolled in the study;
  6. Pending legal action or other reason that, in the opinion of the study physician, might prevent study completion;
  7. Use of medication within 7 days of experimental sessions, which, in the opinion of the Investigator, may interact with cannabis.
  8. Participation in clinical trials or undergoing other investigational procedure involving cannabis or cannabinoids administration within 30 days prior to randomization
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pamela Lachance, PhD 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
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05320367
Other Study ID Numbers  ICMJE 21.361
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Centre hospitalier de l'Université de Montréal (CHUM)
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centre hospitalier de l'Université de Montréal (CHUM)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Didier Jutras-Aswad, MD,MS Centre hospitalier de l'Université de Montréal (CHUM)
PRS Account Centre hospitalier de l'Université de Montréal (CHUM)
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP