Innovative Interventions for Smoking Cessation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only and very low nicotine content cigarette only on abstinence, time to relapse and toxicant levels. The study will determine if adding nicotine replacement medication to the very low content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very low nicotine content cigarettes only.

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Detailed Description

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The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content cigarette (VLNC) compared to the VLNC cigarette alone or 21 mg nicotine patch alone on abstinence, time to relapse and toxicant levels.

The following primary hypothesis will be tested:

Abstinence rates will be highest and the time to relapse will be the longest in the VLNC cigarettes plus nicotine patch condition compared to nicotine patch or VLNC cigarettes alone.

Other hypotheses include:

1. Greater positive subjective responses to cigarettes will be observed with VLNC cigarettes plus patch vs. VLNC cigarette;
2. Less drop-outs will be observed in the VLNC plus patch vs the other two conditions; and
3. Less compensatory smoking will be observed in the VLNC plus patch condition compared to VLNC cigarette alone condition.

Cigarette smokers will be randomized to:

1. VLNC cigarettes (which provide sensory behavioral aspects of smoking but with limited nicotine) plus nicotine patch for 6 weeks;
2. Nicotine patch for 6 weeks; or
3. VLNC cigarettes alone.

Outcome measures will include cessation assessed at the end of treatment as the primary endpoint and at 36 weeks post-treatment, time to lapse and relapse to usual brand cigarettes, and biomarkers of toxicant exposure. Predictors of abstinence and treatment response for each of the treatment conditions will be explored.

Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VLNC Cigarette

Very Low Nicotine Content Cigarette. Dosage: 0.05 mg to 0.09 mg nicotine yield cigarette; Frequency: Daily; Duration: 6 weeks.

Group Type ACTIVE_COMPARATOR

VLNC Cigarette

Intervention Type OTHER

Cigarette where the tobacco contains \<0.1 mg of nicotine yield.

Nicotine Patch

21 mg nicotine patch. Dosage: 21 mg; Frequency: Daily; Duration: 6 weeks.

Group Type ACTIVE_COMPARATOR

Nicotine Patch

Intervention Type DRUG

21 mg

VLNC Cigarette plus Nicotine Patch

Very Low Nicotine Content Cigarette plus 21 mg Nicotine Patch. Patch Dosage: 21 mg; Cigarette Dosasge: 0.05 to 0.09 mg nicotine yield; Frequency: Daily; Duration: 6 weeks

Group Type EXPERIMENTAL

VLNC Cigarette Plus Nicotine Patch

Intervention Type OTHER

21 mg nicotine patch plus use of cigarette with tobacco containing \<0.1 mg nicotine yield.

Interventions

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Nicotine Patch

21 mg

Intervention Type DRUG

VLNC Cigarette

Cigarette where the tobacco contains \<0.1 mg of nicotine yield.

Intervention Type OTHER

VLNC Cigarette Plus Nicotine Patch

21 mg nicotine patch plus use of cigarette with tobacco containing \<0.1 mg nicotine yield.

Intervention Type OTHER

Other Intervention Names

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Nicoderm CQ Quest 3 Xodus Nicoderm CQ Quest 3 Xodus

Eligibility Criteria

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Inclusion Criteria

* a) Smoking at least 10 cigarettes daily for the past year;
* b) In good physical health;
* c) No contraindications for medicinal nicotine; and
* d) Stable, good mental health.

Exclusion Criteria

* a) Subjects must not be using other tobacco or nicotine products.
* b) Female subjects cannot be pregnant or nursing and must be using appropriate birth control.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes