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Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00332644
Recruitment Status : Completed
First Posted : June 2, 2006
Results First Posted : November 30, 2011
Last Update Posted : November 30, 2011
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: nicotine patch Drug: nicotine lozenge Drug: nicotine patch + nicotine lozenge Drug: bupropion Drug: bupropion + lozenge Drug: placebo Phase 4

Detailed Description:
This research study will last for three years. The first year involves a comparison of smoking cessation medications (bupropion, nicotine patch, and nicotine lozenge), including medications used in combination. The results of this study may allow researchers and clinicians to decide which medications are best for helping people to quit smoking as well as what treatments work best for different people. In addition, the first year of this study may help to clarify how these medications work.The purpose of the second and third years of this research study will be to get long-term results on the physical health, mental health, lifestyle factors, and the overall quality of life of people attempting to quit smoking. The results of this study may help researchers and clinicians better understand the health improvements that come from quitting or not quitting smoking.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1504 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacotherapies: Efficacy, Mechanisms and Algorithms
Study Start Date : September 2004
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: 1
nicotine patch alone treatment
Drug: nicotine patch
used according to FDA package label

Experimental: 2
nicotine lozenge alone treatment
Drug: nicotine lozenge
used according to FDA-approved package directions

Experimental: 3
nicotine patch + lozenge combination treatment
Drug: nicotine patch + nicotine lozenge
dosage of both according to FDA-approved dosing schedule

Experimental: 4
bupropion alone treatment
Drug: bupropion
dosage according to FDA-approved instructions

Experimental: 5
bupropion + nicotine lozenge combination treatment
Drug: bupropion + lozenge
dosage according to FDA approved standard instructions

Placebo Comparator: 6
placebo control (no active medication) treatment
Drug: placebo
dosage same as active drug conditions

Primary Outcome Measures :
  1. 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed [ Time Frame: 6 months post quit date ]
    Smoking status was assessed both as 7-day point-prevalence abstinence ("Have you smoked at all, even a puff, in the last 7 days?") and continuous abstinence (smoking at all since the target quit day), using a smoking calendar and the timeline follow-back method. All participants' self-reports of smoking status during study visits were confirmed by an expired carbon monoxide level of less than 10 ppm measured using a Micro-3 Smokerlyzer (Bedfont Scientific, Williamsburg, Virginia).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO > 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments

Exclusion Criteria:

  • Uncontrolled hypertension (systolic >180mm Hg or diastolic >110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00332644

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United States, Wisconsin
UW-CTRI Madison Research site
Madison, Wisconsin, United States, 53711
UW-CTRI Milwaukee Research site
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Timothy B. Baker, PhD University of Wisconsin, Madison

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: University of Wisconsin, Madison Identifier: NCT00332644    
Obsolete Identifiers: NCT00109447
Other Study ID Numbers: P50DA19706-1
P50DA019706 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2006    Key Record Dates
Results First Posted: November 30, 2011
Last Update Posted: November 30, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors