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Cannabinoid

Cannabidiol for Liver Injury

Phase 1

Recruiting

Led By Michaela Wood, MD

Research Sponsored by Food and Drug Administration (FDA)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is a healthy, non-smoking man or woman, 18 to 55 years of age, inclusive, who weighs at least 50 kg (110 lbs) and has a body mass index of 18.5 to 33.0 kg/m2, inclusive, at Screening.

Participants must agree to refrain from using any of the following for the duration of the study: alcohol, nicotine containing products, marijuana or marijuana-derived products, hemp or hemp-derived products, including CBD (except for provided study drug), and illicit drugs of any kind.

Must not have

Subjects with a documented medical history of clinical disorders related to mood, anxiety or panic, including diagnosed depression, generalized anxiety disorder or panic attacks.

Subject has a mean systolic blood pressure <90 or >140 mmHg or a mean diastolic blood pressure <50 or >90 mmHg at either Screening or Check-in. Blood pressure will be measured in triplicate after the subject has been resting in a supine position for a minimum of 5 minutes.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours after each morphine dose (days 1, 4, and 11)

Summary

This trial aims to study the effects of daily use of CBD at a dose similar to what people are taking with unapproved CBD products. The study will specifically look at the impact on liver enzymes, potential

Who is the study for?

This trial is for individuals who are using or considering the use of CBD products. It's important that participants have not experienced severe liver injury in the past and are not currently taking medications known to interact with CBD.

What is being tested?

The study aims to understand how daily use of low-dose CBD affects liver enzymes, potential drug interactions, especially with citalopram and morphine, and endocrine functions. Some participants will receive a placebo instead of actual CBD.

What are the potential side effects?

Possible side effects may include elevated liver enzymes indicating stress on the liver, interactions with other drugs like citalopram or morphine which could alter their effects, and changes in hormone levels.

Eligibility Criteria

Inclusion Criteria

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

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I am a healthy, non-smoking adult between 18-55, weigh at least 110 lbs, and my BMI is between 18.5 to 33.

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I agree not to use alcohol, nicotine, marijuana, hemp products, or illicit drugs during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of mood, anxiety, or panic disorders, including depression or generalized anxiety.

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My blood pressure is not between 90/50 and 140/90 mmHg.

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I am not pregnant, breastfeeding, or have been in the last 3 months.

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I have thought about or attempted suicide in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours after each morphine dose (days 1, 4, and 11)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours after each morphine dose (days 1, 4, and 11)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours after each morphine dose (days 1, 4, and 11) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1 - Percentage of participants with an alanine transaminase (ALT) or aspartate aminotransferase (AST) liver enzyme elevation greater than three times the upper limit of normal (> 3 × ULN).

Part 2 - Comparison of the area under the plasma concentration-time curve (AUC) of citalopram when administered alone versus when co-administered with cannabidiol after 7 days of CBD dosing.

Part 2 - Comparison of the maximum concentration (Cmax) of citalopram when administered alone versus when co-administered with CBD after 7 days of cannabidiol dosing.

+2 more

Secondary study objectives

Part 1 - Change from baseline in free T4 after cannabidiol administration compared to placebo.

Part 1 - Change from baseline in inhibin B in male participants after cannabidiol administration compared to placebo.

Part 1 - Change from baseline in thyroid stimulating hormone (TSH) after cannabidiol administration compared to placebo.

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Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Cannabidiol and Citalopram Drug Interaction (Part 2)Active Control2 Interventions

Subjects in this arm will receive citalopram (20 mg) on Day 1 and Day 13 and oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg cannabidiol daily) for 12 days (Day 6-17).

Group II: Cannabidiol and Morphine Drug Interaction (Part 2)Active Control2 Interventions

Subjects in this arm will receive morphine (15 mg) on Day 1, Day 4, and Day 11 and oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day (5 mg/kg CBD daily) for 9 days (Day 4-12).

Group III: Cannabidiol (Part 1)Active Control1 Intervention

Subjects in this arm will receive oral solution cannabidiol at a dosage of 2.5 mg/kg twice a day, for a total of 5 mg/kg cannabidiol daily for 28 days.

Group IV: Placebo (Part 1)Placebo Group1 Intervention

Subjects in this arm will receive oral solution placebo twice a day for 28 days.

0 / 6Eligibility criteria met