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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

June 1, 2006
October 21, 2011
September 2004
August 2010   (final data collection date for primary outcome measure)
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).
  • smoking cessation
  • carbon monoxide
Complete list of historical versions of study NCT00332644 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms
Pharmacotherapies: Efficacy, Mechanisms and Algorithms

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Nicotine Dependence
  • Drug: nicotine patch
    used according to FDA package label
  • Drug: nicotine lozenge
    used according to FDA-approved package directions
  • Drug: nicotine patch + nicotine lozenge
    dosage of both according to FDA-approved dosing schedule
  • Drug: bupropion
    dosage according to FDA-approved instructions
  • Drug: bupropion + lozenge
    dosage according to FDA approved standard instructions
  • Drug: placebo
    dosage same as active drug conditions
  • Experimental: 1
    nicotine patch alone treatment
    Intervention: Drug: nicotine patch
  • Experimental: 2
    nicotine lozenge alone treatment
    Intervention: Drug: nicotine lozenge
  • Experimental: 3
    nicotine patch + lozenge combination treatment
    Intervention: Drug: nicotine patch + nicotine lozenge
  • Experimental: 4
    bupropion alone treatment
    Intervention: Drug: bupropion
  • Experimental: 5
    bupropion + nicotine lozenge combination treatment
    Intervention: Drug: bupropion + lozenge
  • Placebo Comparator: 6
    placebo control (no active medication) treatment
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1504
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00332644
P50DA19706-1, P50DA019706
No
University of Wisconsin, Madison
University of Wisconsin, Madison
National Institute on Drug Abuse (NIDA)
Principal Investigator: Timothy B. Baker, PhD University of Wisconsin, Madison
University of Wisconsin, Madison
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP