Acceptability of Less Harmful Alternatives to Cigarettes

Study Overview
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Brief Summary
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RATIONALE: A study that evaluates participants' beliefs about smokeless tobacco products and nicotine replacement therapy may be useful in helping smokers stop smoking. PURPOSE: This clinical trial is studying the acceptability of less harmful alternatives to cigarettes.

Detailed Description
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OBJECTIVES: Primary To assess the impact of factual information (a fact sheet) about the relative harms of smokeless (SL)/nicotine replacement (NR) products on participants' beliefs about relative harmfulness. To assess the impact of trying samples of NR and/or SL products on intentions to use such products as alternatives to cigarettes. Secondary To explore the effects of factual information in regard to smoked tobacco on smokers' intentions to use such products as alternatives to cigarettes. To assess potential barriers to use of both NR and SL products as substitutes for cigarettes. To obtain estimates of possible effect sizes for powering a proposed comprehensive test of the likely outcomes of using these products in preference to cigarettes (and other smoked products). OUTLINE: Participants undergo a 10-15 minute web-based survey on a computer in the Tobacco Research Laboratory to assess basic demographic information; beliefs about the relative harmfulness of nicotine replacement (NR) and smokeless (SL) products, including use of relevant questions from the International Tobacco Control (ITC) 4 country survey; past experiences with NR and SL products and perceptions about them; and willingness to try samples of NR/SL products they have not previously used, or, if not willing, reasons for refusal. Participants also receive an information sheet while simultaneously hearing an audio recording of it. Participants complete questionnaires at 2, 3, and 4 weeks. Beginning 2 weeks after study intervention, some participants receive a day's supply of ≤ 4 smokeless tobacco or nicotine products and periodically undergo a breath CO and saliva and buccal cell sample collection. Surveys are completed and samples collected at 3 and 4 weeks.

Official Title
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International Study of the Acceptability of Less Harmful Alternatives to Cigarettes (ISALHAC) - A Pilot Study

Conditions
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Tobacco Use Disorder, Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer

Intervention / Treatment
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* Behavioral: telephone-based intervention
* Drug: nicotine replacement therapy
* Other: informational intervention
* Other: internet-based intervention
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Currently smokes ≥ 10 cigarettes per day Not planning to quit smoking in the next 30 days and has not tried to quit in the past 30 days Medically eligible to receive nicotine-replacement products, based on the NYS Smokers Quitline eligibility criteria PATIENT CHARACTERISTICS: Not pregnant or nursing Able to read and speak English In good general health No history of heart attack or stroke in the past 2 weeks No history of chest pains in the past month No report of physician-diagnosed arrhythmia/irregular heartbeat or use of pacemaker No report of physician-diagnosed heart disease/coronary artery disease, uncontrolled hypertension, stomach ulcer, diabetes, depression, or asthma PRIOR CONCURRENT THERAPY: No other concurrent tobacco products or nicotine medications No concurrent Zyban, Bupropion, Wellbutrin, Chantix, or other smoking cessation medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Overall<br>Single-armed study | Behavioral: telephone-based intervention<br>* 10-15 minute web-based survey on a computer<br>Drug: nicotine replacement therapy<br>* One week supply<br>Other: informational intervention<br> <br> Other: internet-based intervention<br> <br> Other: questionnaire administration<br>* Given out week 2, 3 and 4.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs) |  | Baseline | 
| Number of Participants Willing to Try HRPs |  | Baseline | 
| Number of Participants That Completed 1-week Trial |  | One week | 
| Number of Participants Willing to Continue With Preferred HRP |  | 1 week follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco use disorder, bladder cancer, cervical cancer, esophageal cancer, gastric cancer, renal cell carcinoma, adult primary liver cancer, non-small cell lung cancer, small cell lung cancer, pancreatic cancer, hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, adult acute myeloid leukemia