Clinical trial · Interventional

Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

Comparing the Lozenge to the Patch for Smoking Cessation

NCT00365508CI-TRIAL-00021528completedPhase 4Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (11)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Bladder Cancer	Malignant Bladder Neoplasm	CURATED_EXACT	0.92
Cervical Cancer	Malignant Cervical Neoplasm	CURATED_EXACT	0.92
Esophageal Cancer	Malignant Esophageal Neoplasm	CURATED_EXACT	0.92
Gastric Cancer	Malignant Gastric Neoplasm	CURATED_BROADER	0.80
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90
Kidney Cancer	Malignant Kidney Neoplasm	CURATED_EXACT	0.92
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Liver Cancer	Malignant Liver Neoplasm	CURATED_EXACT	0.92
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Pancreatic Cancer

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
nicotine lozenge	Drug	—	UNRESOLVED
nicotine patch	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm I
description
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.
interventionNames
1. Drug: nicotine patch
type
EXPERIMENTAL
label
Arm II
description
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).
interventionNames
1. Drug: nicotine lozenge

Primary outcomes (1)

measure

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (1)

DERIVEDTheodoulou 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

Registry

Dates and enrollment

Start: Feb 1, 2006
Primary completion: Aug 1, 2009
Completion: Aug 1, 2009
First posted: Aug 17, 2006
Last update posted: Mar 29, 2016
Results first posted: Jan 30, 2013
Enrollment: 642 (actual)
Lead sponsor: Fox Chase Cancer Center OTHER
Collaborators: National Cancer Institute (NCI)
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

Data updated 22 days agoSource updated Mar 29, 2016source: clinicaltrials

Locations

Locations by country (10)

Country	Sites	Recruiting