Grant Abstract: The potential of kava in enabling tobacco cessation - its holistic effects in managing stress and insomnia associated with abstinence
Grant Number: 1R33AT012328-01
PI Name: Xing
Project Title: The potential of kava in enabling tobacco cessation - its holistic effects in managing stress and insomnia associated with abstinence
Abstract: As the leading cause of numerous preventable diseases, smoking results in half a million premature deaths each year in the US and another 16 million American adults living with a serious illness. Indeed, about half of smokers will die of smoking-related problems if they do not quit. Most smokers are aware of such deleterious health effects and have the intention to quit. Tobacco cessation, however, is very challenging, partly due to abstinence- associated stress and insomnia. Current tobacco cessation medications are not designed to address these problems, which have contributed to their limited success in enabling tobacco cessation. There are currently about 34 million American adult smokers and the number is not expected to decrease significantly in the near future. Novel interventions are thus urgently needed that would resolve these challenges, which may significantly improve the success rate of tobacco cessation. On the basis of its traditional history and our preliminary data, kava is such a candidate. Kava is a traditional beverage consumed among the South Pacific Islanders for relaxation, stress reduction, and sleep improvement. It is also marketed as a dietary supplement in the US. Incorporating rigorous safety measures, we completed a pilot trial 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 promising effects on a panel of biological signatures associated with tobacco use, stress, and sleep. The main goal of this R33 application is to replicate the effects of kava on the biological signatures of tobacco use, stress, and sleep in addition to its compliance and safety among smokers. We propose to perform a double-blind randomized placebo controlled three-arm trial among 75 smokers with intention to quit, who will consume AB-free kava at a dietary supplement dose, half of that dose, or placebo, 3 times per day for 4 weeks with two follow-ups. Aim 1 will evaluate the compliance and safety of AB-free kava use among smokers and assess changes in smoking behaviors. Aim 2 will 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 in managing stress and insomnia associated with abstinence. If the results from this study support our hypothesis, kava could emerge as an affordable and accessible dietary supplement candidate for tobacco cessation. PUBLIC HEALTH RELEVANCE: Tobacco use is the leading cause of numerous preventable diseases. Given the limited success of existing tobacco cessation therapies, this proposal aims to evaluate the effects of a specific dietary supplement (kava) on a panel of biological signatures associated with tobacco use, stress, and sleep via a double-blind randomized placebo-controlled three-arm clinical trial with the long-term goal of developing a kava-based tobacco cessation intervention.
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