search
Back to results

A Study of Ingested Cannabidiol in Healthy Occasional Cannabis Users

Primary Purpose

Cannabis

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
cannabis 0 mg, placebo
Cannabis 20 mg,
Cannabis 50 mg
Cannabis 100 mg
Cannabis 200 mg
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 (millimeter of mercury);
  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 Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders ( SCID-V);
  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.

Sites / Locations

  • Centre de recherche du Centre Hospitalier Universitaire de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

0 mg CBD, ingested placebo

20 mg CBD, ingested CBD

50 mg CBD, ingested CBD

100 mg CBD, ingested CBD

200 mg CBD, ingested CBD

Arm Description

Ingested placebo containing 0 mg CBD. 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.

Ingested cannabis containing 20 mg CBD. 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.

Ingested cannabis containing 50 mg CBD. 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.

Ingested cannabis containing 100 mg CBD. 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.

Ingested cannabis containing 200 mg CBD 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).
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 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).
Drug Effects associated with cannabis 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).
Drug Effects associated with cannabis 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).
Drug Effects associated with cannabis 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).
Drug Effects associated with cannabis 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).
Change in dissociation
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
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 the incidence of Treatment Emergent-adverse Events
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)
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

First Posted
June 2, 2022
Last Updated
October 13, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
search

1. Study Identification

Unique Protocol Identification Number
NCT05407285
Brief Title
A Study of Ingested Cannabidiol in Healthy Occasional Cannabis Users
Official Title
A Triple-blind, Placebo-controlled, Randomized, Crossover Study of Low Dose Oral Synthetic Cannabidiol Effects in Healthy Cannabis Occasional Users
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
February 2024 (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 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.
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.

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
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0 mg CBD, ingested placebo
Arm Type
Experimental
Arm Description
Ingested placebo containing 0 mg CBD. 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
20 mg CBD, ingested CBD
Arm Type
Experimental
Arm Description
Ingested cannabis containing 20 mg CBD. 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
50 mg CBD, ingested CBD
Arm Type
Experimental
Arm Description
Ingested cannabis containing 50 mg CBD. 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
100 mg CBD, ingested CBD
Arm Type
Experimental
Arm Description
Ingested cannabis containing 100 mg CBD. 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
200 mg CBD, ingested CBD
Arm Type
Experimental
Arm Description
Ingested cannabis containing 200 mg CBD 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 0 mg, placebo
Other Intervention Name(s)
CBD, placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cannabis 20 mg,
Other Intervention Name(s)
CBD
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cannabis 50 mg
Other Intervention Name(s)
CBD
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cannabis 100 mg
Other Intervention Name(s)
CBD
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cannabis 200 mg
Other Intervention Name(s)
CBD
Intervention Description
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 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 (60 minutes after ingestion)
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 (120 minutes after ingestion)
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 (210 minutes after ingestion)
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
T4 (300 minutes after ingestion)
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
T5 (360 minutes after ingestion)
Secondary Outcome Measure Information:
Title
Drug Effects associated with cannabis ingestion
Description
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).
Time Frame
T1 (60 minutes after ingestion)
Title
Drug Effects associated with cannabis ingestion
Description
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).
Time Frame
T2 (120 minutes after ingestion)
Title
Drug Effects associated with cannabis ingestion
Description
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).
Time Frame
T3 (210 minutes after ingestion)
Title
Drug Effects associated with cannabis ingestion
Description
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).
Time Frame
T4 (300 minutes after ingestion)
Title
Drug Effects associated with cannabis ingestion
Description
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).
Time Frame
T5 (360 minutes after ingestion)
Title
Change in dissociation
Description
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
Time Frame
Baseline and after ingestion at (120 minutes, 300 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
T5 (360 minutes after ingestion)
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 ingestion at (120 minutes, 300 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 ingestion at (120 minutes, 300 minutes)
Title
Change in the incidence of Treatment Emergent-adverse Events
Description
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)
Time Frame
Baseline and after ingestion at (60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 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 ingestion at 210 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 360 minutes after ingestion
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 ingestion.
Time Frame
Baseline and after ingestion at ( 60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)
Title
Change in plasma concentration of 7-Hydroxy-cannabidiol
Description
Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after ingestion.
Time Frame
Baseline and after ingestion at ( 60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 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 ingestion.
Time Frame
Baseline and after ingestion at ( 60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 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 ingestion.
Time Frame
Baseline and after ingestion at ( 60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Lachance-Touchette, Ph.D.
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
Facility Information:
Facility Name
Centre de recherche du Centre Hospitalier Universitaire de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X0A9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Lachance-Touchette, Ph.D
Phone
514 995 5338
Email
pamela.lachance-touchette.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Amina Sow, Ph.D
Phone
514 890 8000
Ext
21491
Email
amina.sow.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Didier Jutras-Aswad, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Ingested Cannabidiol in Healthy Occasional Cannabis Users

We'll reach out to this number within 24 hrs