Acceptability of Less Harmful Alternatives to Cigarettes
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|ClinicalTrials.gov Identifier: NCT00957424|
Recruitment Status : Completed
First Posted : August 12, 2009
Results First Posted : December 14, 2016
Last Update Posted : February 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Cervical Cancer Esophageal Cancer Gastric Cancer Head and Neck Cancer Kidney Cancer Leukemia Liver Cancer Lung Cancer Pancreatic Cancer Tobacco Use Disorder||Behavioral: telephone-based intervention Drug: nicotine replacement therapy Other: informational intervention Other: internet-based intervention Other: questionnaire administration||Not Applicable|
- 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.
- 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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||International Study of the Acceptability of Less Harmful Alternatives to Cigarettes (ISALHAC) - A Pilot Study|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||November 2011|
Behavioral: telephone-based intervention
10-15 minute web-based survey on a computer
Drug: nicotine replacement therapy
One week supply
Other: informational intervention
Other: internet-based intervention
Other: questionnaire administration
Given out week 2, 3 and 4.
- Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs) [ Time Frame: Baseline ]
- Number of Participants Willing to Try HRPs [ Time Frame: Baseline ]
- Number of Participants That Completed 1-week Trial [ Time Frame: One week ]
- Number of Participants Willing to Continue With Preferred HRP [ Time Frame: 1 week follow up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957424
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Martin Mahoney, MD||Roswell Park Cancer Institute|