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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

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.
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.
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 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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured as the time span from laboratory session to time of resumption of ad lib cannabis use (maximum of 10 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cannabis withdrawal symptoms
Stress reactivity
Time to resumption of cannabis use

Side effects data

From 2015 Phase 3 trial • 120 Patients • NCT02091375
31%
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%
Oral herpes
2%
Pneumonia
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
GWP42003-P 20 mg/kg/Day Dose
Placebo

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol oral solution
2022
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
960 Previous Clinical Trials
7,399,412 Total Patients Enrolled
Kevin M Gray, M.D.Principal InvestigatorMedical University of South Carolina

Media Library

Cannabidiol oral solution (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05885542 — Phase 1 & 2
Cannabis Use Disorder Research Study Groups: placebo, cannabidiol 800 mg
Cannabis Use Disorder Clinical Trial 2023: Cannabidiol oral solution Highlights & Side Effects. Trial Name: NCT05885542 — Phase 1 & 2
Cannabidiol oral solution (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05885542 — Phase 1 & 2
~99 spots leftby Jul 2028
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