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The majority of smokers know the health risks associated with smoking and intend to quit. However, quitting is very difficult partly because of insomnia and stress associated with it. Current tobacco cessation medications are not designed to address these problems, which may have contributed to their limited success in enabling cessation. Novel interventions are thus urgently needed to enhance success rates in tobacco cessation. Based on its historical usage and our preliminary data, kava is such a candidate. Kava, customarily enjoyed by South Pacific Islanders, is known for its relaxing effects, stress-relieving properties, and ability to enhance sleep. In the US, it is marketed and distributed as a dietary supplement due to its recognized calming properties. A pilot trial was performed among active smokers with a one-week ingestion of a kava supplement. The results for the first-time revealed kava\u2019s potential in enabling tobacco cessation with effects on a panel of biological signatures. The primary goal of this trial is to replicate kava\u2019s effects on the biological signatures of tobacco use, stress, and sleep in addition to its compliance and safety among those who smoke.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>A double-blind randomized placebo controlled two-arm trial will enroll 76 smokers with intention to quit, who will consume AB-free kava at a dietary supplement dose or placebo, 3 times per day for 4 weeks with two follow-ups.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>The study will (1) monitor the adherence to and safety of AB-free kava consumption among smokers and evaluate changes in smoking habits, and (2) quantify a panel of non-invasive translatable biomarkers to objectively evaluate AB-free kava\u2019s holistic effects on biological signatures associated with tobacco use, stress, and sleep. We hypothesize that AB-free kava is a novel and promising intervention to facilitate tobacco cessation via its holistic effects associated with managing stress and insomnia during abstinence. If the results from this study support our hypothesis, kava could emerge as an affordable and accessible dietary supplement candidate for tobacco cessation.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial Registration<\/jats:title>\n                <jats:p>registered on 04\/14\/2023 in ClinicalTrials.gov with the identifier NCT05814055.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12906-024-04722-9","type":"journal-article","created":{"date-parts":[[2024,12,21]],"date-time":"2024-12-21T08:17:37Z","timestamp":1734769057000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["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"],"prefix":"10.1186","volume":"24","author":[{"given":"Chengguo","family":"Xing","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Malaty","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa Bou","family":"Malham","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank A.","family":"Orlando","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allison","family":"Lynch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiguang","family":"Huo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magda","family":"Fran\u00e7ois","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Firpi-Morell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carla L.","family":"Fisher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Demetra D.","family":"Christou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramzi G.","family":"Salloum","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,12,21]]},"reference":[{"key":"4722_CR1","unstructured":"CDC. 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Eur J Gastroenterol Hepatol. 2008;20:1182\u201393.","journal-title":"Eur J Gastroenterol Hepatol"}],"container-title":["BMC Complementary Medicine and Therapies"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12906-024-04722-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12906-024-04722-9\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12906-024-04722-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,12,21]],"date-time":"2024-12-21T09:02:10Z","timestamp":1734771730000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmccomplementalternmed.biomedcentral.com\/articles\/10.1186\/s12906-024-04722-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12,21]]},"references-count":44,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["4722"],"URL":"https:\/\/doi.org\/10.1186\/s12906-024-04722-9","relation":{},"ISSN":["2662-7671"],"issn-type":[{"value":"2662-7671","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,12,21]]},"assertion":[{"value":"10 July 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 December 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 December 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The trial received approval from the UF IRB approval on 30\/06\/2023 with the IRB number IRB202300887. It is registered in the Clinical Trials Registry under the identifier: NCT05814055 . Prior to enrollment, study coordinators will secure consent from all participants. The informed consent form contains details about data and biological specimen collection, as well as procedures for transcribing interview recordings, in addition to study information.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Thorne used the intellectual properties (IPs) owned by Kuality Herbceutics (KH) to develop the AB-free kava product under investigation. Chengguo Xing, the grant\u2019s PI, holds a 55% ownership stake in KH. Additionally, he offers advises KH regarding its strategic direction and development. As of now, KH has not generated any product or profit from his KH stock. He offers KH with development consultations.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Thorne used the intellectual properties (IPs) owned by Kuality Herbceutics (KH) to develop the AB-free kava product under investigation. Chengguo Xing, the grant\u2019s PI, holds a 55% ownership stake in KH. Additionally, he offers advises KH regarding its strategic direction and development. As of now, KH has not generated any product or profit from his KH stock. He offers KH with development consultations.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declaration of interests"}},{"value":"The study staff are extensively trained in research procedures aimed at safeguarding participants\u2019 privacy and are accustomed to upholding confidentiality in all their activities. Additionally, all team members will complete a human subject training course before the study commences. Any reported or suspected privacy concerns will promptly be communicated to the PI.Multiple measures are implemented to protect the identities of participants. Data files will be coded, and numerical identification codes will be assigned to participants to prevent any potential identification. Informed consent documents will be kept in locked filing cabinets behind closed doors, accessible only to authorized study personnel. Information that includes identifiers will be maintained at a separate site from the study data. Furthermore, the data storage facility will have restricted, key-controlled access, adding an extra layer of security. Data collected during the study will be entered into the HIPAA-compliant REDCap application.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Minimizing potential risk to confidentiality"}},{"value":"No significant adverse events are anticipated from this study; therefore, participants who may experience harm during the trial will not receive compensation.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Post-trial and ancillary care"}},{"value":"All findings will be documented in ClinicalTrials.gov. The results of the trial will be distributed through academic journals that are both open-access and peer-reviewed to ensure broad accessibility will be published in open-access scholarly journals to ensure broad accessibility. The full protocol, complete statistical code and participant-level dataset can be granted via the corresponding author. Additionally, the results will be shared with the public through poster and conference presentations.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Dissemination policy"}},{"value":"0002.0","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Protocol version number"}},{"value":"National Institute of Health: National Center for Complementary and Integrative Health. Recruitment is anticipated to conclude on 06\/2026.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Study Sponsor"}}],"article-number":"422"}}