Phase 2 Sleep Disorders Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Adults between 21 and 75 years old
- People who report smoking at least 5 cigarettes per day for the past year and want to quit at the time of screening
- People whose breath test shows a carbon monoxide level above 8 ppm at the time of recruitment
- People who are willing to take part and sign a consent form
- People who have access to a working telephone
- People who expect to remain in the trial's local area for the next 4 months
- People who are not currently enrolled in any other stop-smoking programs
- Women who could become pregnant must agree to use an accepted form of birth control during the study (accepted methods include birth control pills, a birth control shot, a birth control implant, an IUD, a diaphragm, or a cervical cap)
- People who currently take a kava dietary supplement, or who have previously taken part in a kava-related trial, may still be considered eligible if all other criteria are met and at least 2 weeks have passed since their last use of kava
Who may not be able to join:
- People who have had an active cancer diagnosis (other than a common type of non-serious skin cancer) within the past 2 years
- People who have been diagnosed with liver problems or who have a history of liver disease
- People whose blood test results for certain liver-related markers fall outside the normal range at the pre-screening stage (confirm with trial site)
- People who are unable to avoid taking paracetamol (acetaminophen), drinking more than one alcoholic drink per day, or using other substances that may affect the liver
- People who are pregnant, breastfeeding, planning to become pregnant during the study, or who are of childbearing age and unwilling to use adequate contraception
- People whose responses to a standard set of suicide screening questions (called the Modified Ask Suicide Screening Questions) indicate current risk — specifically, anyone who answers "Yes" to questions 1 through 3, or who refuses to answer all questions. People who answered "Yes" to question 4 but whose most recent suicide attempt was more than 12 months before screening may still be considered eligible
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Ramzi Salloum, PhD, University of Florida
Phone: 352-294-4997
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Subject Compliance with Intervention; Subject Compliance with Intervention
Can't join this trial?
Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.