Acceptability of Less Harmful Alternatives to Cigarettes

NCT00957424 | Completed Results

• 3 other identifiers: CDR0000648665P30CA016056RPCI-I-118207
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Overall

OTHER

Single-armed study

Behavioral: telephone-based intervention; Drug: nicotine replacement therapy; Other: informational intervention; Other: internet-based intervention; Other: questionnaire administration

Interventions

telephone-based intervention BEHAVIORAL

10-15 minute web-based survey on a computer

Overall

nicotine replacement therapy DRUG

One week supply

Overall

informational intervention OTHER

Overall

internet-based intervention OTHER

Overall

questionnaire administration OTHER

Given out week 2, 3 and 4.

Overall

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Uterine Cervical Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Head and Neck Neoplasms; Kidney Neoplasms; Leukemia; Liver Neoplasms; Lung Neoplasms; Pancreatic Neoplasms; Tobacco Use Disorder; Carcinoma, Renal Cell; Carcinoma, Hepatocellular; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Mouth Neoplasms; Nasopharyngeal Neoplasms; Oropharyngeal Neoplasms; Leukemia, Myeloid, Acute

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Kidney Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Mouth Diseases; Nasopharyngeal Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Limitations and Caveats

About 1/3 of initial participants did not complete this study. The limited number of participants precludes identifying demographic predictors of willingness or patterns of substitution. Single armed study lacks comparison group.

Results Point of Contact

• Title: Richard O'Connor
• Organization: Roswell Park Cancer Institute

richard.oconnor@roswellpark.org

716-845-4517

Study Officials

• Martin Mahoney, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 12, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: November 1, 2011
• Last Updated: February 7, 2017
• Results First Posted: December 14, 2016

Record last verified: 2016-12

Locations

US (1)