Acceptability of Less Harmful Alternatives to Cigarettes
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | International Study of the Acceptability of Less Harmful Alternatives to Cigarettes (ISALHAC) - A Pilot Study |
- Percent of participants with no interest in trial of harm-reduction products (HRPs) [ Time Frame: A 10-15 minute web-based survey on a computer ] [ Designated as safety issue: No ]
- Percent of participants willing to try HRPs [ Time Frame: A 10-15 minute web-based survey on a computer ] [ Designated as safety issue: No ]
- Percent of participants that completed 1-week trial [ Time Frame: One week ] [ Designated as safety issue: No ]
- Percent of participants willing to continue with preferred HRP [ Time Frame: 6 months follow up ] [ Designated as safety issue: No ]
| Enrollment: | 67 |
| Study Start Date: | June 2009 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
-
Behavioral: telephone-based intervention
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: This is a multicenter study.
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 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, 4, and 6 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 4 and 6 weeks.
After completion of study intervention, participants are followed up at 6 months by telephone.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Principal Investigator: | Martin Mahoney, MD | Roswell Park Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00957424 History of Changes |
| Other Study ID Numbers: | CDR0000648665, P30CA016056, RPCI-I-118207 |
| Study First Received: | August 11, 2009 |
| Last Updated: | March 5, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Roswell Park Cancer Institute:
|
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 |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Uterine Cervical Neoplasms Esophageal Diseases Esophageal Neoplasms Head and Neck Neoplasms Leukemia Liver Neoplasms Lung Neoplasms Stomach Neoplasms Pancreatic Neoplasms Tobacco Use Disorder Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Kidney Diseases Uterine Neoplasms Genital Neoplasms, Female Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013