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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05814055
• Other study ID #: Kava 2
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2024
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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 Modified Ask Suicide Screening Questions questions 1 through 4, or refuses to answer. If subject answers 'Yes' to question 4 but the most recent suicide attempt took place >12 months from screening visit then subject is still eligible.

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders
• Smoking

Intervention

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

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject Compliance with Intervention	Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses	4 weeks
Primary	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	Tobacco cessation	Examine whether kava has the potential to help facilitate tobacco cessation, as measured by participant reported number of cigarettes smoked	12 weeks
Secondary	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
Secondary	Tobacco cessation	Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Modified Cigarette Evaluation Questionnaire (mCEQ)	12 weeks
Secondary	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
Secondary	Tobacco cessation	Examine whether kava has the potential to help facilitate tobacco cessation, as measured by urinary total nicotine equivalents	12 weeks
Secondary	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
Secondary	Effect on stress	Examine whether kava has the potential to reduce stress, as measured by plasma PRKACA	12 weeks
Secondary	Effect on stress	Examine whether kava has the potential to reduce stress, as measured by plasma cortisol	12 weeks
Secondary	Effect on stress	Examine whether kava has the potential to reduce stress, as measured by urinary TCE	12 weeks
Secondary	Effect on stress	Examine whether kava has the potential to reduce stress, as measured by total cortisol equivalents	12 weeks
Secondary	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
Secondary	Effect on sleep	Examine whether kava has the potential to improve sleep, as measured by the Pittsburgh Sleep Quality Index (PSQI)	12 weeks
Secondary	Effect on sleep	Examine whether kava has the potential to improve sleep, as measured by urinary 6-hydroxymelatonin	12 weeks
Secondary	Effect on sleep	Examine whether kava has the potential to improve sleep, as measured by urinary N-acetyl serotonin	12 weeks
Secondary	Effect on sleep	Examine whether kava has the potential to improve sleep, as measured by urinary NAS	12 weeks