Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05081882 · ClinicalTrials.gov registry record · Phase 2
Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava
A Phase 2 study of Smoking, sponsored by University of Florida.
- Active
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05081882: Active Phase 2 study of Smoking, sponsored by University of Florida.
NCT05081882 is a Phase 2 study of Smoking that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 20 participants, below the 455-participant average among 123 other Smoking trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05081882, a Phase 2 study of Smoking, is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Tobacco use is the leading cause of many preventable diseases, particularly lung cancer. Based on the national cancer data in 2020, Florida has the highest lung cancer incidence (18,150 cases) with the most deaths (10,580 deaths) among all the states in the United States. Unfortunately, around 16% of adults in Florida continue to smoke cigarettes due to its addictive nature and the limited success of current cessation strategies. Therefore, there is an unmet and urgent need for novel interventions to improve the success of tobacco cessation. If such an intervention can reduce tobacco-associated lung carcinogenesis, that will be more desirable. The ultimate goal of this study is to develop a safe and effective kava-based intervention to enable tobacco cessation and reduce lung cancer risk, which will improve the health of Floridians. This study will evaluate the compliance with a daily kava regimen among active smokers who have no intention to quit smoking. This study will also investigate whether kava use can reduce tobacco use and dependence, as well as tobacco-associated lung carcinogenesis.
Primary Outcome
Measure urinary total nicotine equivalents (TNE). TNE is the sum of nicotine and its metabolites in a participant's urine. TNE was measured at baseline (on Day 1 of treatment), after 1 and 2 weeks on treatment, at the end of treatment, at 4 weeks after end of treatment and at 8 weeks after end of treatment.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Kava
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-06-09 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What the registry record for NCT05081882 still lists
NCT05081882 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 455-participant average among 123 other Smoking trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Smoking appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05081882 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05081882 about?
NCT05081882 is a clinical study titled "Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava". Tobacco use is the leading cause of many preventable diseases, particularly lung cancer. Based on the national cancer data in 2020, Florida has the highest lung cancer incidence (18,150 cases) with the most deaths (10,580 deaths) among all the states in the United States. Unfortunately, around 16% o...
What is the current status of trial NCT05081882?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2022-06-09. Estimated completion is 2026-12.
What conditions does trial NCT05081882 study?
This clinical trial studies the following conditions: Smoking.
What interventions are being tested in trial NCT05081882?
The interventions under investigation include: Placebo (DRUG), Kava (DRUG).
Who is sponsoring clinical trial NCT05081882?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05081882 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Smoking
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05081882's enrollment target sits among peer trials
20 117th of 123 higher than 6 of 123 other Smoking trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Smoking trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence
RECRUITING · Phase 2
-
A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse
RECRUITING · Phase 2
-
App for Reducing Cravings to Smoke
RECRUITING · Phase 2
-
Proactive Health Intervention for Tobacco Users (Get PHIT)
COMPLETED · Phase 2
-
Computer-Assisted Intervention for Smoking During Pregnancy
COMPLETED · Phase 2
-
Oxidative Stress and Vitamin E Requirements
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI