The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT05814055
Phase
PHASE2
Status
Recruiting
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Conditions

  • Smoking

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Participants on this arm will take one placebo capsule orally three times daily for 4 weeks.
  • AB-free kava — DRUG
    Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 4 weeks.

Study Details

This study will evaluate the compliance with a daily kava regimen among active smokers who have an intention to quit smoking. This study will also investigate whether kava use can facilitate tobacco cessation, reduce stress, and improve sleep.

Key Dates

Start date
Jun 6, 2024
Status verified
Dec 2025
Primary completion
Jan 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: AB-free kava
  • Placebo Comparator: Placebo control

Primary Outcome Measure

Subject Compliance with Intervention [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32608
Melissa Malham
[email protected]
352-294-5892
Ramzi Salloum, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Florida· Gainesville, FL

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