Kava for Smoking Cessation
Recruiting in Palo Alto (17 mi)
RS
Overseen byRamzi Salloum, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Florida
Must not be taking: Acetaminophen, Alcohol
Disqualifiers: Cancer, Liver dysfunction, Pregnancy, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking a kava dietary supplement, you will need to stop for a 2-week period before starting the study.
Is kava safe for human use?
How does the treatment Kava differ from other smoking cessation treatments?
Kava is unique as a smoking cessation treatment because it is a herbal product, which is a type of complementary and alternative medicine (CAM). Unlike nicotine replacement therapies like patches or gum, Kava may appeal to those interested in herbal and natural remedies, although its effectiveness for smoking cessation is not well-documented.678910
Research Team
RS
Ramzi Salloum, PhD
Principal Investigator
University of Florida
Eligibility Criteria
This trial is for adults over 21 who smoke at least 10 cigarettes a day, want to quit, and have high carbon monoxide levels from smoking. They must live in the study area for 4 months, not be in other quit programs, and if they can become pregnant, use reliable birth control.Inclusion Criteria
I am willing to participate in this study.
Access to a functional telephone
Not currently enrolled in any smoking cessation programs
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Exclusion Criteria
Levels of alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin over limit of normal (ULN) range at prescreen
I have liver problems or a history of liver disease.
Use any other non-cigarette nicotine containing products such as smokeless tobacco, cigar or e-cigarettes
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a daily kava regimen to evaluate compliance and its effects on tobacco cessation, stress, and sleep
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Kava (Herbal Supplement)
- Placebo (Placebo)
Trial OverviewThe study tests if kava helps smokers quit by reducing stress and improving sleep. Participants will follow a daily kava regimen or take a placebo without knowing which one they're getting to compare the effects on quitting success.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AB-free kavaExperimental Treatment1 Intervention
Group II: Placebo controlPlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of FloridaGainesville, FL
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Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
Trials
1428
Patients Recruited
987,000+
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Trials
886
Patients Recruited
677,000+
National Institutes of Health (NIH)
Collaborator
Trials
2896
Patients Recruited
8,053,000+
References
Measuring the chemical and cytotoxic variability of commercially available kava (Piper methysticum G. Forster). [2021]Formerly used world-wide as a popular botanical medicine to reduce anxiety, reports of hepatotoxicity linked to consuming kava extracts in the late 1990s have resulted in global restrictions on kava use and have hindered kava-related research. Despite its presence on the United States Food and Drug Administration consumer advisory list for the past decade, export data from kava producing countries implies that US kava imports, which are not publicly reported, are both increasing and of a fairly high volume. We have measured the variability in extract chemical composition and cytotoxicity towards human lung adenocarcinoma A549 cancer cells of 25 commercially available kava products. Results reveal a high level of variation in chemical content and cytotoxicity of currently available kava products. As public interest and use of kava products continues to increase in the United States, efforts to characterize products and expedite research of this potentially useful botanical medicine are necessary.
Kava-Kava extract LI 150 is as effective as Opipramol and Buspirone in Generalised Anxiety Disorder--an 8-week randomized, double-blind multi-centre clinical trial in 129 out-patients. [2019]An 8-week randomized, reference-controlled, double-blind, multi-centre clinical trial investigated Kava-Kava LI 150 in Generalized Anxiety Disorder (GAD; ICD-10: F41.1).
An Updated Review on the Psychoactive, Toxic and Anticancer Properties of Kava. [2022]Kava (Piper methysticum) has been widely consumed for many years in the South Pacific Islands and displays psychoactive properties, especially soothing and calming effects. This plant has been used in Western countries as a natural anxiolytic in recent decades. Kava has also been used to treat symptoms associated with depression, menopause, insomnia, and convulsions, among others. Along with its putative beneficial health effects, kava has been associated with liver injury and other toxic effects, including skin toxicity in heavy consumers, possibly related to its metabolic profile or interference in the metabolism of other xenobiotics. Kava extracts and kavalactones generally displayed negative results in genetic toxicology assays although there is sufficient evidence for carcinogenicity in experimental animals, most likely through a non-genotoxic mode of action. Nevertheless, the chemotherapeutic/chemopreventive potential of kava against cancer has also been suggested. Both in vitro and in vivo studies have evaluated the effects of flavokavains, kavalactones and/or kava extracts in different cancer models, showing the induction of apoptosis, cell cycle arrest and other antiproliferative effects in several types of cancer, including breast, prostate, bladder, and lung. Overall, in this scoping review, several aspects of kava efficacy and safety are discussed and some pertinent issues related to kava consumption are identified.
A systematic review of the safety of kava extract in the treatment of anxiety. [2018]This paper systematically reviews the clinical evidence relating to the safety of extracts of the herbal anxiolytic kava (Piper methysticum). Literature searches were conducted in four electronic databases and the reference lists of all papers located were checked for further relevant publications. Information was also sought from the spontaneous reporting schemes of the WHO and national drug safety bodies and ten manufacturers of kava preparations were contacted. Data from short-term post-marketing surveillance studies and clinical trials suggest that adverse events are, in general, rare, mild and reversible. However, published case reports indicate that serious adverse events are possible including dermatological reactions, neurological complications and, of greatest concern, liver damage. Spontaneous reporting schemes also suggest that the most common adverse events are mild, but that serious ones occur. Controlled trials suggest that kava extracts do not impair cognitive performance and vigilance or potentiate the effects of central nervous system depressants. However, a possible interaction with benzodiazepines has been reported. It is concluded that when taken as a short-term monotherapy at recommended doses, kava extracts appear to be well tolerated by most users. Serious adverse events have been reported and further research is required to determine the nature and frequency of such events.
Kava as a Clinical Nutrient: Promises and Challenges. [2021]Kava beverages are typically prepared from the root of Piper methysticum. They have been consumed among Pacific Islanders for centuries. Kava extract preparations were once used as herbal drugs to treat anxiety in Europe. Kava is also marketed as a dietary supplement in the U.S. and is gaining popularity as a recreational drink in Western countries. Recent studies suggest that kava and its key phytochemicals have anti-inflammatory and anticancer effects, in addition to the well-documented neurological benefits. While its beneficial effects are widely recognized, rare hepatotoxicity had been associated with use of certain kava preparations, but there are no validations nor consistent mechanisms. Major challenges lie in the diversity of kava products and the lack of standardization, which has produced an unmet need for quality initiatives. This review aims to provide the scientific community and consumers, as well as regulatory agencies, with a broad overview on kava use and its related research. We first provide a historical background for its different uses and then discuss the current state of the research, including its chemical composition, possible mechanisms of action, and its therapeutic potential in treating inflammatory and neurological conditions, as well as cancer. We then discuss the challenges associated with kava use and research, focusing on the need for the detailed characterization of kava components and associated risks such as its reported hepatotoxicity. Lastly, given its growing popularity in clinical and recreational use, we emphasize the urgent need for quality control and quality assurance of kava products, pharmacokinetics, absorption, distribution, metabolism, excretion, and foundational pharmacology. These are essential in order to inform research into the molecular targets, cellular mechanisms, and creative use of early stage human clinical trials for designer kava modalities to inform and guide the design and execution of future randomized placebo controlled trials to maximize kava's clinical efficacy and to minimize its risks.
Complementary treatments for tobacco cessation: a survey. [2022]Little information is available regarding the prevalence of use and interest in future use of complementary and alternative medicine (CAM) for tobacco cessation among tobacco users. We conducted a self-administered anonymous survey among 1,175 patients seen at a midwestern outpatient tobacco treatment specialty clinic between November 2003 and July 2005. Patient use of CAM for tobacco cessation, perceived efficacy of these treatments, and interest in future use of CAM were ascertained. Data were summarized using descriptive statistics, and logistic regression models were used to determine the characteristics associated with past CAM use or interest in future use of CAM for tobacco cessation. All of the patients who received the survey completed it. A total of 27% of patients reported previous use of CAM for tobacco cessation. The interventions most commonly used were hypnosis, relaxation, acupuncture, and meditation. CAM treatments most commonly perceived to be efficacious were yoga, relaxation, meditation, and massage therapy. A total of 67% of the patients reported interest in future use of CAM for tobacco cessation. The treatments of greatest interest for use in the future were hypnosis, herbal products, acupuncture, relaxation, and massage therapy. Female gender, previous use of conventional tobacco cessation products, previous use of CAM treatments, and a higher level of education were significantly associated with interest in future CAM use. The high level of interest in CAM among tobacco users underscores the need to conduct further research in this field.
Smoking cessation products and programs. [2007]Behavioral treatment techniques have facilitated smoking cessation, with intensive multicomponent interventions sometimes producing long-term abstinence rates approaching 50%. There is little evidence that either hypnosis or acupuncture are effective. Both nicotine gum and nicotine patch significantly improve treatment outcomes, although patch is easier for patients to use correctly. Self-help programs may be of benefit, however, smoking cessation products other than nicotine replacement show little evidence of effectiveness. Health professionals should be informed consumers and should be skeptical in evaluating claims for commercial programs or products. Additional information and materials are available from a number of sources including the National Cancer Institute, the U.S. Office on Smoking and Health, and the voluntary health organizations.
Meta-analysis of studies investigating one-year effectiveness of transdermal nicotine patches for smoking cessation. [2019]The one-year effectiveness of transdermal nicotine patches versus placebo patches for smoking cessation based on continuous or sustained abstinence was studied.
Alternative smoking cessation aids: a meta-analysis of randomized controlled trials. [2019]Acupuncture, hypnotherapy, and aversive smoking are the most frequently studied alternative smoking cessation aids. These aids are often used as alternatives to pharmacotherapies for smoking cessation; however, their efficacy is unclear.
Three year continuous abstinence in a smoking cessation study using the nicotine transdermal patch. [2019]A total of 305 subjects from Sydney were randomly allocated to receive either an active (24 hour transdermal nicotine patch over a 10 week course) or placebo nicotine patch. All subjects participated in a multicomponent cognitive-behavioural smoking cessation programme over five weeks in two-hour group sessions. The continuous abstinence rates at three years (validated by expired carbon monoxide) were 13.8% for the active group and 5.2% for placebo group (p = 0.011). The active nicotine patch with behavioural therapy achieved more than double the abstinence rates early in treatment compared with placebo and this difference was maintained throughout the three year follow up.