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New treatment option for Smoking
Official title The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence
ClinicalTrials.gov ID: NCT05814055
What this study is testing
What is AB-free kava?
AB-free kava is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for smoking.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 75
You may be able to join if
- adults aged 21 years or above (legal age for smoking in the U.S.) up to 75 years old;
- self-reported smoking at least 5 cigarettes/day for the past year with INTENTION to quit at time of screening visit;
- expired carbon monoxide level of more than 8 ppm at recruitment;
- willingness to participate in the proposed study, as indicated by signed informed consent;
- access to a functional telephone;
You likely can't join if
- history of active cancer (other than non-melanoma skin cancer) within the past 2 years;
- 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;
- 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 3, or refuses to answer all of the questions...
See the full eligibility criteria
- adults aged 21 years or above (legal age for smoking in the U.S.) up to 75 years old;
- self-reported smoking at least 5 cigarettes/day for the past year with INTENTION to quit at time of screening visit;
- expired carbon monoxide level of more than 8 ppm at recruitment;
- willingness to participate in the proposed study, as indicated by signed informed consent;
- 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 per self report; and
- female people 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...
- if a participant takes kava dietary supplement, a 2-week washout period is needed for the participant to initiate this study or if a participant participated in a kava trial before, such as the kava JEK trial, the...
- history of active cancer (other than non-melanoma skin cancer) within the past 2 years;
- 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;
- 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 3, or refuses to answer all of the questions. If subject answers 'Yes' to question 4 but the most recent suicide...
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.