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Cannabinoid

Cannabidiol for Cannabis Use Disorder

Phase 2

Recruiting

Led By Christian J Hopfer, MD

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

Ages 18-25

Be between 18 and 65 years old

Must not have

Current use of strong or moderate CYP2C19 inhibitors or inducers

For female participants, pregnancy or trying to become pregnant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 hour pre and post thc self-administration at baseline, 4 weeks, and 8 weeks

Awards & highlights

Summary

This trial will look at how hemp-derived CBD can reduce harm in young adults who regularly use cannabis. The study will use a unique method to observe how participants use cannabis in a natural setting, using a

Who is the study for?

This trial is for young adults who regularly use cannabis but aren't seeking treatment. Participants must be users of either flower or concentrate cannabis products and will be randomly assigned to receive either hemp-derived CBD or a placebo.

What is being tested?

The study is testing the effects of Broad Spectrum Cannabidiol (bsCBD) at a dose of 400 mg compared to a placebo in reducing harm from regular cannabis use. The research involves using a mobile lab to monitor real-world consumption patterns.

What are the potential side effects?

While specific side effects are not listed, typical CBD-related side effects may include tiredness, diarrhea, changes in appetite/weight, and potential interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 25 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 enzyme CYP2C19.

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I am not pregnant nor trying to become pregnant.

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I am currently breastfeeding.

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I have or had liver disease.

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I have a heart or lung condition.

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I have been diagnosed or treated for a serious mental health condition.

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I am currently taking medication for mental health or liver-affecting drugs.

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I am not taking any strong or moderate drugs that affect 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 hour pre and post thc self-administration at baseline, 4 weeks, and 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 hour pre and post thc self-administration at baseline, 4 weeks, and 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour pre and post thc self-administration at baseline, 4 weeks, and 8 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 THC levels

Difference in blood THC-COOH levels

Difference in cannabis use

Other study objectives

Adverse effects

Difference in blood CBD levels

Trial Design

2Treatment 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: PlaceboPlacebo Group1 Intervention

A medically inert placebo medication will be used as described in the study arms.

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,543 Previous Clinical Trials

3,249,176 Total Patients Enrolled

University of Colorado, DenverLead Sponsor

1,786 Previous Clinical Trials

2,787,408 Total Patients Enrolled

Christian J Hopfer, MDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus

~133 spots leftby Jun 2028

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