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.

Autor:	Xing C; College of Pharmacy, University of Florida, Gainesville, FL, USA. chengguoxing@cop.ufl.edu., Malaty J; College of Medicine, University of Florida, Gainesville, FL, USA., Malham MB; College of Medicine, University of Florida, Gainesville, FL, USA., Orlando FA; College of Medicine, University of Florida, Gainesville, FL, USA., Lynch A; College of Pharmacy, University of Florida, Gainesville, FL, USA., Huo Z; College of Medicine, University of Florida, Gainesville, FL, USA., François M; College of Medicine, University of Florida, Gainesville, FL, USA., Firpi-Morell R; College of Medicine, University of Florida, Gainesville, FL, USA., Fisher CL; College of Medicine, University of Florida, Gainesville, FL, USA., Christou DD; College of Health and Human Performance, University of Florida, Gainesville, FL, USA., Salloum RG; College of Medicine, University of Florida, Gainesville, FL, USA. rsalloum@ufl.edu.
Jazyk:	angličtina
Zdroj:	BMC complementary medicine and therapies [BMC Complement Med Ther] 2024 Dec 21; Vol. 24 (1), pp. 422. Date of Electronic Publication: 2024 Dec 21.
DOI:	10.1186/s12906-024-04722-9
Abstrakt:	Background: As the primary cause of various preventable illnesses, smoking results in approximately five million premature deaths each year in the US and a multitude of adults living with serious illness. 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's potential in enabling tobacco cessation with effects on a panel of biological signatures. The primary goal of this trial is to replicate kava's effects on the biological signatures of tobacco use, stress, and sleep in addition to its compliance and safety among those who smoke. Methods: 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. Discussion: 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's 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. Trial Registration: registered on 04/14/2023 in ClinicalTrials.gov with the identifier NCT05814055. Competing Interests: Declarations. Ethics approval and consent to participate: 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 https://clinicaltrials.gov/study/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. Competing interests: Thorne used the intellectual properties (IPs) owned by Kuality Herbceutics (KH) to develop the AB-free kava product under investigation. Chengguo Xing, the grant’s 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. Declaration of interests: Thorne used the intellectual properties (IPs) owned by Kuality Herbceutics (KH) to develop the AB-free kava product under investigation. Chengguo Xing, the grant’s 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. Minimizing potential risk to confidentiality: The study staff are extensively trained in research procedures aimed at safeguarding participants’ 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. Post-trial and ancillary care: No significant adverse events are anticipated from this study; therefore, participants who may experience harm during the trial will not receive compensation. Dissemination policy: 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. Protocol version number: 0002.0 Study Sponsor: National Institute of Health: National Center for Complementary and Integrative Health. Recruitment is anticipated to conclude on 06/2026. (© 2024. The Author(s).)
Databáze:	MEDLINE
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