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Happy Lane Hemp Extract/CBD soft gels (25 mg/capsule) for Healthy Subjects

Q: Are there any vacancies available for participants of this trial?

Clinicaltrials.gov states that this research initiative, which was initially published on December 1st 2022 and revised most recently in January 10th of the same year, is not accepting applicants currently. However, 839 other trials are actively seeking participants right now.

Q: Are octogenarians being granted admittance to this experiment?

The current clinical trial is only open to individuals aged between 18 and 45. By contrast, there are 50 experiments available for minors and 371 studies intended for seniors.

Q: Are there any criteria that would permit me to partake in this clinical trial?

This clinical trial seeks 20 participants aged 18 to 45 who self-identify as healthy subjects (HS). Eligible candidates must also attest that they will not use any prescription or OTC drugs and/or supplements during the study period, abstain from using other cannabinoid products for duration of the research, and meet age requirements.

Phase < 1

Waitlist Available

Led By Igor Koturbash, MD, PhD

Research Sponsored by University of Arkansas

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 13 days

Awards & highlights

Study Summary

This trial will determine the levels of major cannabinoids and cannabinoid metabolites in the plasma of healthy volunteers following 10 days of supplementation with 25 mg CBD soft gels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 13 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~13 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Amount of 11-OH-THC in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS

Amount of CBD in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS

Amount of CBD-OH in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: 50 mg/day dose of Happy Lane CBD (Larger Dose)Experimental Treatment1 Intervention

Two 25 mg Happy Lane CBD gel capsules per day (50 mg/day total dose) for 10 consecutive days at approximately the same time of day (±1 hour) on each of these days. Both capsules will be taken at the same time as each other.

Group II: 25 mg/day dose of Happy Lane CBD (Lower Dose)Experimental Treatment1 Intervention

One 25 mg Happy Lane CBD gel capsule per day (25 mg/day total dose) for 10 consecutive days at approximately the same time of day (±1 hour) on each of these days.

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Who is running the clinical trial?

University of ArkansasLead Sponsor

486 Previous Clinical Trials

150,353 Total Patients Enrolled

Igor Koturbash, MD, PhDPrincipal InvestigatorUniversity of Arkansas

Frequently Asked Questions

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

Are there any vacancies available for participants of this trial?

"Clinicaltrials.gov states that this research initiative, which was initially published on December 1st 2022 and revised most recently in January 10th of the same year, is not accepting applicants currently. However, 839 other trials are actively seeking participants right now."

Answered by AI

Are octogenarians being granted admittance to this experiment?

"The current clinical trial is only open to individuals aged between 18 and 45. By contrast, there are 50 experiments available for minors and 371 studies intended for seniors."

Answered by AI

Are there any criteria that would permit me to partake in this clinical trial?

"This clinical trial seeks 20 participants aged 18 to 45 who self-identify as healthy subjects (HS). Eligible candidates must also attest that they will not use any prescription or OTC drugs and/or supplements during the study period, abstain from using other cannabinoid products for duration of the research, and meet age requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Determination of Cannabinoid and Cannabinoid Metabolite Levels in Healthy Volunteers

2023. "Determination of Cannabinoid and Cannabinoid Metabolite Levels in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04997616.