Recruiting NCT05814055
The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, AB-free kava.
- Who it may be relevant to
- Registry conditions: Smoking. Basic parameters: 21 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Primary outcome measures
- Subject Compliance with Intervention [Time frame: 4 weeks]
- Subject Compliance with Intervention [Time frame: 4 weeks]
Secondary outcome measures (12)
- Tobacco cessation [Time frame: 12 weeks]
- Tobacco cessation [Time frame: 12 weeks]
- Tobacco cessation [Time frame: 12 weeks]
- Tobacco cessation [Time frame: 12 weeks]
- Tobacco cessation [Time frame: 12 weeks]
- Effect on stress [Time frame: 12 weeks]
- Effect on stress [Time frame: 12 weeks]
- Effect on stress [Time frame: 12 weeks]
- Effect on stress [Time frame: 12 weeks]
- Effect on stress [Time frame: 12 weeks]
- Effect on sleep [Time frame: 12 weeks]
- Effect on sleep [Time frame: 12 weeks]
Eligibility criteria
Inclusion 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 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).
- 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 participant could be enrolled if the inclusion criteria above are met, including the 2-week washout period.
Exclusion criteria
- 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 attempt took place >12 months from screening visit then subject is still eligible.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Florida — Gainesville
Publications
- Xing C, Malaty J, Malham MB, Orlando FA, Lynch A, Huo Z, Francois M, Firpi-Morell R, Fisher CL, Christou DD, Salloum RG. The potential of AB-free kava in enabling tobacco cessation via management of abstinence-related stress and insomnia: study protocol for a randomized clinical trial. BMC Complement Med Ther. 2024 Dec 21;24(1):422. doi: 10.1186/s12906-024-04722-9. PMID 39709468
Identifiers
NCT: NCT05814055 · Kava 2 · OCR44061 · IRB202300887 · 1R33AT012328-01