Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation (NCT01341938) | Clinical Trial Compass
CompletedNot Applicable
Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation
United States1,067 participantsStarted 2011-07
Plain-language summary
This research study will determine if using a combination of 4-mg nicotine lozenges, self-help materials, and/or telephone tobacco cessation counseling will help smokeless tobacco users stop using tobacco. The study will consist of three interventions:
1. The Lozenge Assisted Self-help intervention - lozenge nicotine replacement therapy, phone counseling, and self help materials
2. Assisted Self-Help intervention - self-help materials and phone counseling without lozenges
3. Lozenge Self Help intervention - self help materials and lozenge nicotine replacement therapy.
Hypothesis: The Lozenge Assisted Self-help intervention will significantly increase both the prolonged and point prevalence for all tobacco and smokeless tobacco (ST) abstinence rates at 6 months among ST users who are interested in achieving tobacco abstinence, compared to those in the Assisted Self-Help intervention and the Lozenge Self Help intervention.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years old or over
* Currently using smokeless tobacco products as primary tobacco product
* Use smokeless tobacco for the last 6 months
* Currently want to quit
* Able to read and write English; and
* Willing to share phone number, e-mail, and mailing address with the research project
* complete informed consent process
Exclusion Criteria:
* have used behavioral or pharmacologic tobacco treatment in last 30 days
* medical history of unstable angina, myocardial infarction within the past 6 months, cardiac dysrhythmia other than medication-controlled atrial fibrillation or PSVT or medically treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic
* have phenylketonuria (PKU)
* have another member of their household already participating in this study
* currently pregnant or nursing
* score of ≥ 15 on the Patient Health Questionnaire (PHQ-8)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.