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The potential of kava in enabling tobacco cessation - its holistic effects in managing stress and insomnia associated with abstinence

Award Number: R33AT012328
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2023
PERIOD OF PERFORMANCE END DATE: 01/31/2027

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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 two-arm trial among 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. 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $505,477 )
2026	2026	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Research and Training in Complementary and Integrative Health	000	3	4/21/2026	NON-COMPETING CONTINUATION	$505,477
														Subtotal = $505,477

Issue Date FY: 2025 ( Subtotal = $461,592 )
2025	2025	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Research and Training in Complementary and Integrative Health	000	2	2/13/2025	NON-COMPETING CONTINUATION	$461,592
														Subtotal = $461,592

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Research and Training in Complementary and Integrative Health	000	1	5/8/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $522,987 )
2023	2023	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Research and Training in Complementary and Integrative Health	000	1	7/20/2023	NEW	$522,987
2023	2023	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Research and Training in Complementary and Integrative Health	001	1	7/21/2023	NEW	$0
														Subtotal = $522,987

Grand Total All Awards = $1,490,056

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The potential of kava in enabling tobacco cessation - its holistic effects in managing stress and insomnia associated with abstinence

Award Number: R33AT012328

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2023

PERIOD OF PERFORMANCE END DATE: 01/31/2027

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