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Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00332644
First received: June 1, 2006
Last updated: October 21, 2011
Last verified: October 2011
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Timothy B. Baker, PhD University of Wisconsin, Madison
  More Information

Additional Information:
No publications provided by University of Wisconsin, Madison

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Bupropion
Nicotine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Agonists
Dopamine Agents
Dopamine Uptake Inhibitors
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014