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

NCT05814055 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-01-27

No results posted yet for this study

Summary

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.

Conditions

  • Smoking

Interventions

DRUG

Placebo

Participants on this arm will take one placebo capsule orally three times daily for 4 weeks.

DRUG

AB-free kava

Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 4 weeks.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Ramzi Salloum, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-06
Primary Completion
2027-01-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05814055 on ClinicalTrials.gov