NCT00365508 · REGISTRY CONDITION SEARCH

Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE4
Status at capture: COMPLETED
Registry last update: 2016-03-29

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Rate of Compliance During the First 2 Weeks

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Drug: nicotine patch
label
Arm I
type
EXPERIMENTAL
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).
intervention Names
Drug: nicotine lozenge
label
Arm II
type
EXPERIMENTAL

interventions

arm Group Labels
Arm II
description
nicotine lozenge
name
nicotine lozenge
type
DRUG
arm Group Labels
Arm I
description
transdermal nicotine patch
name
nicotine patch
other Names
transdermal nicotine patch
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

FACTORIAL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 642
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
24-hour Point Prevalence Abstinence at the 6-month Follow up
time Frame
6-months

secondary Outcomes

description
Applied to use of the intervention (number of lozenges/day or number of patches used per week) not considering abstinence
measure
Rate of Compliance During the First 2 Weeks
time Frame
2 weeks

Full study description

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.
detailed Description: OBJECTIVES: Primary * Compare the efficacy of behavioral counseling and nicotine-replacement therapy with either oral nicotine lozenge (NL) or transdermal nicotine patch (NP), in terms of promoting rates of smoking cessation (e.g., continued abstinence), in adult smokers. * Examine the degree to which nicotine replacement therapy (NRT) preference, desire to control NRT dosing, irregular smoking schedules, and desire for oral preoccupation moderates the relative efficacy of NL vs NP in promoting smoking cessation. * Evaluate the impact of the NL on mediators of smoking cessation (i.e., reduced craving, diminished withdrawal symptoms, cue reactivity, and increased perceived control over withdrawal symptoms). Secondary * Compare the rate of compliance with NRT across the 2 treatment arms and examine if compliance rate mediates the effects of NRT on quit rates. * Examine the potential role of genes related to nicotine dependence such as genes related to nicotine metabolism enzymes (e.g., CYP1A1) or genes related to dopamine concentrations (e.g., DRD2). OUTLINE: This is a randomized, open-label, multicenter study. Participants are stratified according to study center. Participants are randomized to 1 of 2 intervention arms. All participants undergo smoking cessation counseling in weeks 1, 3, 5, 7, and 9. Beginning in week 3, participants are asked to quit smoking for 12 weeks (weeks 3-14). * Arm I: 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. * Arm II: 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). The moderating variables (e.g., nicotine replacement-therapy \[NRT\] preference and the smoker's desire to control NRT dosing) are assessed at baseline. The mediating variables (i.e., reduced craving, diminished withdrawal symptoms, cue reactivity, and increased perceived control over withdrawal symptoms) are assessed at baseline and then at weeks 5, 7, 9, within weeks 14-16, and within weeks 26-28. Continuous abstinence will be measured at week 27. PROJECTED ACCRUAL: A total of 700 participants will be accrued for this study.

Source references

references

citation
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
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice