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Kavalactones

Kava (Piper methysticum) extract for Sleep

N/A
Waitlist Available
Led By Michael A Schmidt, PhD, MPhil
Research Sponsored by Thorne HealthTech, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or older
Provides consent to participate in the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 8, and 15
Awards & highlights

Study Summary

This research study is being done to better understand the effects of kava supplementation on sleep quality and salivary cortisol in the context of the acute physical and psychological stress of military special forces preparation training. Kava is a botanical dietary supplement derived from the plant Piper methysticum. Cortisol is a hormone associated with stress.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 8, and 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 8, and 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Salivary Cortisol - Phase 1
Change in Salivary Cortisol - Phase 2
Change in Sleep Latency, Duration, and Quality - Phase 1
+1 more
Secondary outcome measures
Change in General Mood - Phase 1
Change in General Mood - Phase 2
Change in Motivation and Volition - Phase 1
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo to Active (Cohort 2)Experimental Treatment1 Intervention
Participants randomly allocated to Cohort 2 for Phase 1 will begin the study taking the placebo and will cross-over to taking the active ingredient in Phase 2 of the study after a washout period.
Group II: Active to Placebo (Cohort 1)Experimental Treatment1 Intervention
Participants randomly allocated to Cohort 1 for Phase 1 will begin the study taking the active ingredient and will cross-over to taking placebo in Phase 2 of the study after a washout period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Kava (Piper methysticum) extract
2022
N/A
~20

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Who is running the clinical trial?

Thorne HealthTech, IncLead Sponsor
10 Previous Clinical Trials
665 Total Patients Enrolled
1 Trials studying Sleep
201 Patients Enrolled for Sleep
Thorne Research Inc.Lead Sponsor
10 Previous Clinical Trials
665 Total Patients Enrolled
1 Trials studying Sleep
201 Patients Enrolled for Sleep
Performance FirstUNKNOWN

Frequently Asked Questions

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~5 spots leftby Mar 2025