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Cannabinoid

Cannabidiol for Cannabis Use Disorder

Phase 2
Recruiting
Led By Joseph P Schacht, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 25-60
Be between 18 and 65 years old
Must not have
Current use of strong or moderate CYP3A4 inhibitors or inducers
Currently use of anti-epileptic medications or medications known to have major interactions with Epidiolex or a history of seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Summary

This trial is testing if plant-derived cannabidiol (CBD) can reduce cannabis concentrate use and cravings among regular cannabis concentrate users. Participants will take either CBD (200 mg or 400 mg per

Who is the study for?
This trial is for individuals who regularly use cannabis concentrates but aren't looking to reduce their usage. Participants must be willing to take CBD or a placebo and attend three study visits using a mobile lab.
What is being tested?
The study tests if plant-derived CBD at doses of 200 mg or 400 mg per day can lower the use, effects, or craving of cannabis compared to a placebo. It's randomized and controlled, meaning participants are put into groups by chance.
What are the potential side effects?
While not explicitly listed here, common side effects of CBD may include tiredness, diarrhea, changes in appetite/weight. However, specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 25 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medication that strongly affects liver enzymes.
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I am taking anti-epileptic drugs or drugs that interact with Epidiolex, or I have a history of seizures.
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I have or had liver disease.
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I am not pregnant nor trying to become pregnant.
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I am not willing to use birth control while on the study medication.
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I have been diagnosed or treated for a serious mental health condition.
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I have a heart or lung condition.
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I am currently taking medication for mental health or liver-affecting drugs.
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I am currently taking medication that strongly affects liver enzyme CYP2C19.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in blood 11-Nor-9-carboxy-THC (THC-COOH) levels
Difference in blood delta-9-tetrahydrocannabinol (THC) levels
Difference in cannabis use
Secondary study objectives
Difference in cannabis craving
Difference in cannabis-induced anxiety and negative affect
Difference in cannabis-induced intoxication
+2 more
Other study objectives
Adverse effects
Difference in blood cannabidiol (CBD) levels

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Broad Spectrum Cannabidiol (bsCBD) 400 mgActive Control1 Intervention
bsCBD in a 400 mg dose will be used as described in the study arms.
Group II: Broad Spectrum Cannabidiol (bsCBD) 200 mgActive Control1 Intervention
bsCBD in a 200 mg dose will be used as described in the study arms.
Group III: PlaceboPlacebo Group1 Intervention
A medically inert placebo medication will be used as described in the study arms.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,256 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,786 Previous Clinical Trials
2,787,488 Total Patients Enrolled
Joseph P Schacht, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus
4 Previous Clinical Trials
447 Total Patients Enrolled
~80 spots leftby Jun 2028
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