Back to resultsA Study of Inhaled Cannabidiol in Healthy Occasional Cannabis Users
Primary Purpose
Cannabis
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Cannabis, placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cannabis
Eligibility Criteria
Inclusion Criteria:
- Between 21 and 65 years of age, inclusively;
- Have used cannabis at least once in lifetime AND have 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;
- Have a forced expiratory volume in first second (FEV) sup 90 %;
- 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 must 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;
- 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-5 (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 cannabis.
- Participation in clinical trials or undergoing other investigational procedure involving cannabis or cannabinoids administration within 30 days prior to randomization
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
CBD (Group 1)
CBD (Group 2)
CBD (Group 3)
CBD (Group 4)
CBD (Group 5)
Arm Description
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
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
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.
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.
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.
Outcomes
Primary Outcome Measures
Pleasant drug effect
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
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
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
Drug Effects associated with cannabis administration
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
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
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
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
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
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
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
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
The Cambridge Neuropsychological Test Automated Battery tests will be used for the rapid assessment of multiple cognitive components.
Visit Intoxication Assessment
Signs of intoxication will be assess using the modified Standardized Field Sobriety Test.
Full Information
NCT ID
NCT05320367
First Posted
March 20, 2022
Last Updated
May 15, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT05320367
Brief Title
A Study of Inhaled Cannabidiol in Healthy Occasional Cannabis Users
Official Title
A Randomized, Triple Blinded Cross-over Placebo Controlled Study of Effects of Inhaled Cannabidiol in Healthy Occasional Cannabis Users
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBD (Group 1)
Arm Type
Experimental
Arm Description
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
Arm Title
CBD (Group 2)
Arm Type
Experimental
Arm Description
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
Arm Title
CBD (Group 3)
Arm Type
Experimental
Arm Description
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.
Arm Title
CBD (Group 4)
Arm Type
Experimental
Arm Description
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.
Arm Title
CBD (Group 5)
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Cannabis, placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pleasant drug effect
Description
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).
Time Frame
T1(10 minutes after inhalation)
Title
Pleasant drug effect
Description
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).
Time Frame
T2 (60 minutes after inhalation)
Title
Pleasant drug effect
Description
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).
Time Frame
T3 (120 minutes after inhalation)
Secondary Outcome Measure Information:
Title
Drug Effects associated with cannabis administration
Description
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).
Time Frame
T1 (10 minutes after inhalation)
Title
Drug Effects associated with cannabis administration
Description
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).
Time Frame
T2 (60 minutes after inhalation)
Title
Drug Effects associated with cannabis administration
Description
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).
Time Frame
T3 (120 minutes after inhalation)
Title
Change in dissociation
Description
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.
Time Frame
Baseline and after inhalation at (10 minutes, 60 minutes)
Title
Cannabis-Specific Subjective Effects
Description
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).
Time Frame
T3 (120 minutes after inhalation)
Title
Change in Affect
Description
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.
Time Frame
Baseline and after inhalation at (10 minutes, 60 minutes, 120 minutes)
Title
Change in Anxiety Symptoms
Description
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).
Time Frame
Baseline and after inhalation at (10 minutes, 60 minutes and 120 minutes)
Title
Change in Safety
Description
Adverse events will be collected prior to administration of the study product (T0) and following administration of the study product (T1, T2 and T3)
Time Frame
Baseline and after inhalation at (10 minutes, 60 minutes, 120 minutes)
Title
Change on cognition
Description
The Cambridge Neuropsychological Test Automated Battery tests will be used for the rapid assessment of multiple cognitive components.
Time Frame
Baseline and after inhalation at T2 (60 minutes).
Title
Visit Intoxication Assessment
Description
Signs of intoxication will be assess using the modified Standardized Field Sobriety Test.
Time Frame
End of the visit, approximatively 180 minutes after inhalation
Other Pre-specified Outcome Measures:
Title
Change in plasma concentration of CBD
Description
Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after inhalation.
Time Frame
Baseline and after inhalation at ( 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes)
Title
Change in plasma concentration of 7-Hydroxycannabidiol
Description
Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after inhalation.
Time Frame
Baseline and after inhalation at ( 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes)
Title
Change in plasma concentration of 7-Carboxy-Cannabidiol
Description
Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after inhalation.
Time Frame
Baseline and after inhalation at ( 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes)
Title
Change in plasma concentration of Anandamide
Description
Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after inhalation.
Time Frame
Baseline and after inhalation at ( 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Between 21 and 65 years of age, inclusively;
Have used cannabis at least once in lifetime AND have 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;
Have a forced expiratory volume in first second (FEV) sup 90 %;
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 must 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;
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-5 (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 cannabis.
Participation in clinical trials or undergoing other investigational procedure involving cannabis or cannabinoids administration within 30 days prior to randomization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Lachance, PhD
Phone
514-890-8000
Ext
30938
Email
pamela.lachance-touchette.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Didier Jutras-Aswad, MD,MS
Phone
514-890-8000
Ext
35703
Email
didier.jutras-aswad@umontreal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Jutras-Aswad, MD,MS
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Inhaled Cannabidiol in Healthy Occasional Cannabis Users
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