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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking
• Intervention / Treatment: Drug: AB-free kava; Drug: AB-free kava; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adults aged 21 years or above (legal age for smoking in the U.S.);
• self-reported smoking at least 10 cigarette/day for the past year with INTENTION to quit;
• expired carbon monoxide level of more than 8 ppm at recruitment;
• willingness to participate in the proposed study;
• access to a functional telephone;
• expected presence in the study's geographical area for the next 4 months;
• not currently enrolled in any smoking cessation programs; and
• female subjects of childbearing potential will be required to practice acceptable methods of birth control (the acceptable methods of birth control include birth control pills, Birth Control Shot, Birth Control Implant, IUD, Diaphragm, and cervical cap).

Exclusion Criteria:

• diagnosed with cancer (other than non-melanoma skin cancer);
• diagnosed with liver dysfunction or with previous liver diseases;
• levels of alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin over limit of normal (ULN) range at prescreen;
• inability to refrain from acetaminophen, alcohol (no more than one drink daily via self-report), or other potentially hepatotoxic substances;
• use any other non-cigarette nicotine containing products such as smokeless tobacco, cigar or e-cigarettes; or
• are pregnant or nursing (lactating) or of childbearing age planning to become pregnant or unwilling to use adequate contraception during the study;
• participant answered "Yes" to any of the ASQ questions 1 through 4, or refuses to answer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo control	Drug: Placebo; Participants on this arm will take one placebo capsule orally three times daily for 4 weeks.
Experimental: Full dose kava intervention	Drug: AB-free kava; Participants on this arm will take one kava capsule (each capsule contains 37.5 mg of kavalactones) 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.
Experimental: Half dose kava intervention	Drug: AB-free kava; Participants on this arm will take one kava capsule (each capsule contains 37.5 mg of kavalactones) 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Compliance with Intervention	Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses	4 weeks
Subject Compliance with Intervention	Evaluate subject compliance with the kava intervention, as measured by detection of dihydromethysticin in participant urine by urine testing	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco cessation	Examine whether kava has the potential to help facilitate tobacco cessation, as measured by participant reported number of cigarettes smoked	12 weeks
Tobacco cessation	Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Fagerström Test for Nicotine Dependence (FTND)	12 weeks
Tobacco cessation	Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Modified Cigarette Evaluation Questionnaire (mCEQ)	12 weeks
Tobacco cessation	Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Brief Questionnaire on Smoking Urges (QSU-Brief)	12 weeks
Tobacco cessation	Examine whether kava has the potential to help facilitate tobacco cessation, as measured by urinary total nicotine equivalents	12 weeks
Effect on stress	Examine whether kava has the potential to reduce stress, as measured by plasma PRKACA	12 weeks
Effect on stress	Examine whether kava has the potential to reduce stress, as measured by plasma cortisol	12 weeks
Effect on stress	Examine whether kava has the potential to reduce stress, as measured by urinary TCE	12 weeks
Effect on stress	Examine whether kava has the potential to reduce stress, as measured by total cortisol equivalents	12 weeks
Effect on sleep	Examine whether kava has the potential to improve sleep, as measured by the Pittsburgh Sleep Quality Index (PSQI)	12 weeks
Effect on sleep	Examine whether kava has the potential to improve sleep, as measured by urinary 6-hydroxymelatonin	12 weeks
Effect on sleep	Examine whether kava has the potential to improve sleep, as measured by urinary N-acetyl serotonin	12 weeks
Effect on sleep	Examine whether kava has the potential to improve sleep, as measured by urinary NAS	12 weeks
Effect on stress	Examine whether kava has the potential to reduce stress, as measured by the Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 items that are each scored on a scale of 0-4. The maximum possible score for this instrument is 40 and the minimum score is 0. A higher score indicates greater perceived stress.	12 weeks
Effect on sleep	Examine whether kava has the potential to improve sleep, as measured by the Insomnia Severity Scale. The Insomnia Severity Scale instrument consists of 7 items that are each scored on a scale of 0-4. The maximum possible score for this instrument is 28 and the minimum score is 0. A higher score indicates more severe insomnia.	12 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Ramzi Salloum, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: smoking cessation; tobacco dependence; kava
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: Kava 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No