Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms - Full Text View

Sponsor:	University of Wisconsin, Madison
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00332644

Purpose

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

Condition	Intervention	Phase
Nicotine Dependence	Drug: nicotine patch Drug: nicotine lozenge Drug: nicotine patch + nicotine lozenge Drug: bupropion Drug: bupropion + lozenge Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Pharmacotherapies: Efficacy, Mechanisms and Algorithms

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Nicotine tartrate Bupropion hydrochloride Bupropion Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed [ Time Frame: 6 months post quit date ] [ Designated as safety issue: No ]
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).

Enrollment:	1504
Study Start Date:	September 2004
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332644

Locations

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)

Investigators

Principal Investigator:

Timothy B. Baker, PhD

University of Wisconsin, Madison

More Information

Additional Information:

home page of agency performing the research This link exits the ClinicalTrials.gov site

No publications provided by University of Wisconsin, Madison

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Asthana A, Piper ME, McBride PE, Ward A, Fiore MC, Baker TB, Stein JH. Long-term effects of smoking and smoking cessation on exercise stress testing: three-year outcomes from a randomized clinical trial. Am Heart J. 2012 Jan;163(1):81-87.e1. Epub 2011 Nov 14.

Julius BR, Ward BA, Stein JH, McBride PE, Fiore MC, Colbert LH. Ambulatory activity associations with cardiovascular and metabolic risk factors in smokers. J Phys Act Health. 2011 Sep;8(7):994-1003.

Johnson HM, Gossett LK, Piper ME, Aeschlimann SE, Korcarz CE, Baker TB, Fiore MC, Stein JH. Effects of smoking and smoking cessation on endothelial function: 1-year outcomes from a randomized clinical trial. J Am Coll Cardiol. 2010 May 4;55(18):1988-95. Epub 2010 Mar 17.

Responsible Party:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00332644 History of Changes
Obsolete Identifiers:	NCT00109447
Other Study ID Numbers:	P50DA19706-1, P50DA019706
Study First Received:	June 1, 2006
Results First Received:	October 21, 2011
Last Updated:	October 21, 2011
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists

Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012