Acceptability of Less Harmful Alternatives to Cigarettes

Roswell Park Comprehensive Cancer Center

Status

Completed

Conditions

Tobacco Use Disorder

Bladder Cancer

Gastric Cancer

Esophageal Cancer

Lung Cancer

Kidney Cancer

Leukemia

Head and Neck Cancer

Liver Cancer

Cervical Cancer

Pancreatic Cancer

Treatments

Other: questionnaire administration

Other: informational intervention

Behavioral: telephone-based intervention

Other: internet-based intervention

Drug: nicotine replacement therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00957424

P30CA016056 (U.S. NIH Grant/Contract)

RPCI-I-118207

CDR0000648665

Details and patient eligibility

About

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.

Full description

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.

Enrollment

67 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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