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Cannabinoid
Cannabidiol for Cannabis Use Disorder
Phase 1 & 2
Recruiting
Led By Kevin M Gray, M.D.
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured as the time span from laboratory session to time of resumption of ad lib cannabis use (maximum of 10 days)
Awards & highlights
Study Summary
This trial will study the effects of cannabis use and stress among young adults with cannabis use disorder to create tailored treatments. #cannabis #mentalhealth
Who is the study for?
This trial is for young adults aged 18-25 with Cannabis Use Disorder (CUD), using cannabis at least five times a week. They must see cannabis as their main substance, have normal liver function tests, and agree to use birth control if applicable. Participants can't be pregnant or on certain medications that interact with CBD, and should not have severe mental health issues or other serious substance abuse problems.Check my eligibility
What is being tested?
The study is testing the effects of Cannabidiol (CBD) oral solution versus a placebo in managing stress related to cannabis use in emerging adults. It aims to understand sex differences in this context to develop better treatments for CUD.See study design
What are the potential side effects?
While specific side effects are not listed here, CBD may cause tiredness, diarrhea, changes in appetite/weight. However, since it's being compared with a placebo which has no active ingredients, any additional side effects would be closely monitored.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured as the time span from laboratory session to time of resumption of ad lib cannabis use (maximum of 10 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured as the time span from laboratory session to time of resumption of ad lib cannabis use (maximum of 10 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cannabis withdrawal symptoms
Stress reactivity
Time to resumption of cannabis use
Side effects data
From 2015 Phase 3 trial • 120 Patients • NCT0209137531%
Diarrhoea
31%
Somnolence
26%
Decreased appetite
18%
Fatigue
15%
Vomiting
15%
Pyrexia
11%
Upper respiratory tract infection
11%
Lethargy
8%
Convulsion
7%
Weight decreased
7%
Gamma-glutamyltransferase increased
7%
Irritability
7%
Cough
7%
Transaminases increased
5%
Status epilepticus
5%
Nasopharyngitis
2%
Pneumonia
2%
Oral herpes
2%
Platelet count
2%
Abdominal distension
2%
Abdominal pain
2%
Gastrointestinal haemorrhage
2%
Asthenia
2%
Lower respiratory tract infection
2%
Gamma-glutamyltransferase
2%
Hypophagia
2%
Hypotonia
2%
Myoclonus
2%
Respiratory failure
2%
Epistaxis
2%
Hypovolaemic shock
2%
Aspartate aminotransferase increased
2%
Liver function test abnormal
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
GWP42003-P 20 mg/kg/Day Dose
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: cannabidiol 800 mgExperimental Treatment1 Intervention
Cannabidiol 800 mg will be administered orally once in the laboratory prior to a stress induction paradigm.
Group II: placeboPlacebo Group1 Intervention
Placebo (formulated to appear identical to active condition) administered orally once in the laboratory prior to a stress induction paradigm.
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,488 Total Patients Enrolled
Kevin M Gray, M.D.Principal InvestigatorMedical University of South Carolina
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, nursing, or planning to become pregnant during the study.I am not taking any medications or supplements that interact with cannabidiol.I can understand and agree to the study's requirements.I use effective birth control methods.I am between 18 and 25 years old.
Research Study Groups:
This trial has the following groups:- Group 1: placebo
- Group 2: cannabidiol 800 mg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research study require participants to be of legal age?
"According to the established requirements, participants must be 18 or older but no more than 25 years old."
Answered by AI
How can I get involved in this clinical research endeavor?
"Patients who are between 18 and 25 years old, with a diagnosis of cannabis use disorder, may be eligible for acceptance into this clinical trial. The team behind the study aims to recruit 148 participants in total."
Answered by AI
Does this research endeavor currently require additional participants?
"According to the data hosted at clinicaltrials.gov, this particular study is not currently accepting applications from patients. The trial was originally posted on August 1st 2023 and last edited on May 30th 2023. Fortunately, there are still 118 other trials open for recruitment right now."
Answered by AI
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