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Cannabinoid

Ingested Cannabidiol for Cannabis Abuse

Phase 1 & 2
Waitlist Available
Led By Didier Jutras-Aswad, MD,MS
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and after ingestion at (60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)
Awards & highlights

Study Summary

This trialexamines the effects of 4 different doses of CBD on the body, to see if they produce a pleasant effect that can't be detected with current research tools.

Who is the study for?
This trial is for healthy adults aged 21-65 who occasionally use cannabis (3 days or less in the past month). They must understand English or French, not be pregnant or planning pregnancy, and agree to birth control if applicable. Participants can't join if they have serious medical conditions, liver disease, high blood pressure, a fast heart rate, extreme obesity (BMI over 40), severe psychiatric disorders, current substance abuse (other than nicotine), or are taking certain medications.Check my eligibility
What is being tested?
The study tests whether low doses of oral CBD (20 mg to 200 mg) cause any pleasant effects compared to a placebo. It also explores whether these doses produce effects that aren't picked up by current research tools. The participants will receive varying amounts of CBD including a placebo randomly.See study design
What are the potential side effects?
While the trial aims to assess low-dose CBD's effects which may include mild side effects such as drowsiness or dry mouth; it doesn’t specify them. However, common side effects of higher dose CBD can include changes in appetite and mood swings.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and after ingestion at (60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and after ingestion at (60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pleasant drug effect
Secondary outcome measures
Cannabis-Specific Subjective Effects
Change in Affect
Change in Anxiety Symptoms
+5 more
Other outcome measures
Change in plasma concentration of 7-Carboxy-Cannabidiol
Change in plasma concentration of 7-Hydroxy-cannabidiol
Change in plasma concentration of Anandamide
+1 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: 50 mg CBD, ingested CBDExperimental Treatment5 Interventions
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.
Group II: 200 mg CBD, ingested CBDExperimental Treatment5 Interventions
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.
Group III: 20 mg CBD, ingested CBDExperimental Treatment5 Interventions
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.
Group IV: 100 mg CBD, ingested CBDExperimental Treatment5 Interventions
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.
Group V: 0 mg CBD, ingested placeboExperimental Treatment5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cannabis 0 mg, placebo
2022
Completed Phase 2
~70
Cannabis 20 mg,
2022
Completed Phase 2
~70
Cannabis 50 mg
2022
Completed Phase 2
~70
Cannabis 100 mg
2022
Completed Phase 2
~70
Cannabis 200 mg
2022
Completed Phase 2
~70

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
369 Previous Clinical Trials
129,767 Total Patients Enrolled
3 Trials studying Cannabis
980 Patients Enrolled for Cannabis
Didier Jutras-Aswad, MD,MSPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
1 Previous Clinical Trials
80 Total Patients Enrolled
1 Trials studying Cannabis
80 Patients Enrolled for Cannabis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to become a participant in this experiment?

"This medical investigation will include 70 people who are of age between 21 and 65, and have only used cannabis infrequently (3 days or less) in the four weeks prior to enrollment. To be considered for participation, a signed informed consent must be produced by all applicants as well as their agreement to abstain from any non-alcoholic/nicotine drugs during the study period. Furthermore, those with childbearing potential must present a negative pregnancy test at screening and subsequent visits along with a promise not to become pregnant while on trial; they also need to use an accepted contraceptive method throughout the duration of this research. Finally, fluency in either"

Answered by AI

Is this study actively enrolling participants?

"This study, as displayed on clinicaltrials.gov, is still enrolling participants and was first announced in late July 2022 before undergoing a significant edit towards the end of November that same year."

Answered by AI

Is the age eligibility for this clinical trial restricted to individuals 50 and over?

"This investigation has imposed an age restriction of between 21 to 65. Conversely, there are 16 separate trials tailored for people who have not reached the legal age and 53 studies designated for those above retirement-age."

Answered by AI

What is the participant capacity for this research project?

"Affirmative. The clinicaltrials.gov platform attests to the fact that this medical trial, initiated on July 22nd 2022, is in an active recruitment phase. 70 volunteers need to be sourced from a single location for the study's completion."

Answered by AI

Who else is applying?

What state do they live in?
Quebec
What site did they apply to?
Centre de recherche du Centre Hospitalier Universitaire de Montréal
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

i have raging adhd and anxiety.
PatientReceived 2+ prior treatments
~25 spots leftby May 2025