Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

NCT00365508 | Completed Phase 4 Results

• 3 other identifiers: CDR0000491296FCCC-FCRB-04-003-P05-818
• Study Type: interventional
• Target: 642
• Locations: 1 country
• Sites: 10

Brief Summary

RATIONALE: Stop-smoking plans, including counseling and nicotine replacement therapy, may help smokers quit smoking. It is not yet known whether counseling and the nicotine lozenge is more effective than counseling and the nicotine patch in helping adult smokers quit smoking. PURPOSE: This randomized phase III trial is studying counseling and the nicotine lozenge to see how well they work compared to counseling and the nicotine patch in helping smokers quit smoking.

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

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; tongue cancer; tobacco use disorder

Outcome Measures

Primary Outcomes (1)

• 24-hour Point Prevalence Abstinence at the 6-month Follow up

  6-months

Secondary Outcomes (1)

• Rate of Compliance During the First 2 Weeks

  2 weeks

Study Arms (2)

Arm I

EXPERIMENTAL

Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.

Drug: nicotine patch

Arm II

EXPERIMENTAL

Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).

Drug: nicotine lozenge

Interventions

nicotine lozenge DRUG

nicotine lozenge

Arm II

nicotine patch DRUG

transdermal nicotine patch

Also known as: transdermal nicotine patch

Arm I

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Smokes at least 10 cigarettes a day on average for the past year * No prior diagnosis of cancer (unless completed treatment AND no evidence of disease within the past 5 years) * Able to use nicotine replacement therapy PATIENT CHARACTERISTICS: * Able to communicate in English * Must reside in the geographic area for ≥ 6 months * Current asthma, ulcer, or diabetes allowed provided medical clearance from the participant's physician is obtained * No evidence of drug or alcohol abuse * No known HIV positivity * No heart disease, including any of the following: * Current diagnosis of coronary artery disease * Abnormal heart rhythm or an arrhythmia * Heart failure * Heart valve disease * Congenital heart disease * Heart muscle disease or cardiomyopathy * Pericardial disease * Aorta disease * Vascular disease * Myocardial infarction * High blood pressure (defined as blood pressure \> 140/90 mm Hg) not receiving antihypertensive medication * History of or current high blood pressure controlled by antihypertensive medication and having medical clearance from physician allowed * No allergy to adhesive tape or latex * Not pregnant or nursing * Negative pregnancy test * Fertile participants must use effective contraception during and for ≥ 1 month prior to and after completion of study treatment PRIOR CONCURRENT THERAPY: * At least 30 days since prior and no concurrent benzodiazepine (e.g., diazepam, alprazolam, or lorazepam) * At least 6 months since prior antiretroviral medications * At least 6 months since prior and no concurrent medication for depression (e.g., phenelzine sulfate, pargyline hydrochloride, tranylcypromine sulfate, paroxetine hydrochloride, sertraline hydrochloride, fluoxetine hydrochloride) * No concurrent antipsychotics (e.g., lithium) or theophylline * No concurrent substance abuse treatment * No concurrent bupropion hydrochloride * No other concurrent pharmacologic aid or any other form of formal assistance for smoking cessation

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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (10)

Howard University Cancer Center

Washington D.C., District of Columbia, 20060, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Medical College of Georgia Cancer Center

Augusta, Georgia, 30912-3500, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Burlington County

Mount Holly, New Jersey, 08060-2099, United States

Location

Hematology Oncology Associates of Central New York, PC - Northeast Center

East Syracuse, New York, 13057-4510, United States

Location

Don Monti Comprehensive Cancer Center at North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, 17822-0001, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

CCOP - Main Line Health

Wynnewood, Pennsylvania, 19096, United States

Location

Nashville General Hospital at Meharry

Nashville, Tennessee, 37208, United States

Location

Related Publications (1)

• Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

  PMID: 39868569 DERIVED

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; Tongue Neoplasms

Interventions

Tobacco Use Cessation Devices

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; Tongue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

The study was an effectiveness trial so external vs. internal validity was emphasized. Many participants were lost to follow-up.

Results Point of Contact

• Title: Robert Schnoll
• Organization: University of Pennsylvania

schnoll@mail.med.upenn.edu

215-746-7143

Study Officials

• Robert A. Schnoll, PhD

  Fox Chase Cancer Center - Cheltenham

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2006
• First Posted: August 17, 2006
• Study Start: February 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 29, 2016
• Results First Posted: January 30, 2013

Record last verified: 2016-03

Locations

US (10)