Trials / Recruiting
RecruitingNCT05814055
The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- Sponsor
- University of Florida · Academic / Other
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Participants on this arm will take one placebo capsule orally three times daily for 4 weeks. |
| DRUG | AB-free kava | Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 4 weeks. |
Timeline
- Start date
- 2024-06-06
- Primary completion
- 2027-01-31
- Completion
- 2027-10-31
- First posted
- 2023-04-14
- Last updated
- 2026-01-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05814055. Inclusion in this directory is not an endorsement.