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Cannabinoid

Cannabidiol and Citalopram Drug Interaction (Part 2) 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.

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)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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.

+7 more

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 / 2Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Spaulding Clinical Research LLCOTHER

22 Previous Clinical Trials

1,060 Total Patients Enrolled

Food and Drug Administration (FDA)Lead Sponsor

171 Previous Clinical Trials

1,331,366 Total Patients Enrolled

Michaela Wood, MDPrincipal InvestigatorSpaulding Clinical Research LLC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently eligible to participate in this ongoing medical study?

"According to the information available on clinicaltrials.gov, this particular study is not currently seeking participants. The original posting date was February 1st, 2024, and the most recent update occurred on December 18th, 2023. However, it's important to note that there are currently 17 other ongoing clinical trials accepting new patients at this time."

Answered by AI

Are individuals older than 20 years eligible to participate in this medical trial?

"In adherence to the eligibility requirements, potential participants must be at least 18 years old and no older than 55."

Answered by AI

Is it possible for me to participate in this medical study as a subject?

"To be eligible for this medical investigation, potential participants should have no drug interactions and fall between the ages of 18 and 55. A total of 240 individuals will be recruited for this study."

Answered by AI

Has the Food and Drug Administration granted official approval for the use of Cannabidiol (Part 1)?

"Our team at Power assigns a safety rating of 1 to Cannabidiol (Part 1) based on its Phase 1 trial status. This indicates that there is currently limited data available regarding both the safety and efficacy of this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions

2024. "Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06192589.

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