Back to resultsSmoking Cessation Medications: Efficacy, Mechanisms and Algorithms
Primary Purpose
Nicotine Dependence
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
nicotine patch
nicotine lozenge
nicotine patch + nicotine lozenge
bupropion
bupropion + lozenge
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Dependence
Eligibility 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
Sites / Locations
- UW-CTRI Madison Research site
- UW-CTRI Milwaukee Research site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
5
6
Arm Description
nicotine patch alone treatment
nicotine lozenge alone treatment
nicotine patch + lozenge combination treatment
bupropion alone treatment
bupropion + nicotine lozenge combination treatment
placebo control (no active medication) treatment
Outcomes
Primary Outcome Measures
7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT00332644
First Posted
June 1, 2006
Last Updated
October 21, 2011
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00332644
Brief Title
Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms
Official Title
Pharmacotherapies: Efficacy, Mechanisms and Algorithms
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1504 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
nicotine patch alone treatment
Arm Title
2
Arm Type
Experimental
Arm Description
nicotine lozenge alone treatment
Arm Title
3
Arm Type
Experimental
Arm Description
nicotine patch + lozenge combination treatment
Arm Title
4
Arm Type
Experimental
Arm Description
bupropion alone treatment
Arm Title
5
Arm Type
Experimental
Arm Description
bupropion + nicotine lozenge combination treatment
Arm Title
6
Arm Type
Placebo Comparator
Arm Description
placebo control (no active medication) treatment
Intervention Type
Drug
Intervention Name(s)
nicotine patch
Intervention Description
used according to FDA package label
Intervention Type
Drug
Intervention Name(s)
nicotine lozenge
Intervention Description
used according to FDA-approved package directions
Intervention Type
Drug
Intervention Name(s)
nicotine patch + nicotine lozenge
Intervention Description
dosage of both according to FDA-approved dosing schedule
Intervention Type
Drug
Intervention Name(s)
bupropion
Intervention Description
dosage according to FDA-approved instructions
Intervention Type
Drug
Intervention Name(s)
bupropion + lozenge
Intervention Description
dosage according to FDA approved standard instructions
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
dosage same as active drug conditions
Primary Outcome Measure Information:
Title
7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed
Description
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).
Time Frame
6 months post quit date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy B. Baker, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
UW-CTRI Madison Research site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711
Country
United States
Facility Name
UW-CTRI Milwaukee Research site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29251951
Citation
Burgess-Hull AJ, Roberts LJ, Piper ME, Baker TB. The social networks of smokers attempting to quit: An empirically derived and validated classification. Psychol Addict Behav. 2018 Feb;32(1):64-75. doi: 10.1037/adb0000336. Epub 2017 Dec 18.
Results Reference
derived
PubMed Identifier
25867447
Citation
McCarthy DE, Ebssa L, Witkiewitz K, Shiffman S. Paths to tobacco abstinence: A repeated-measures latent class analysis. J Consult Clin Psychol. 2015 Aug;83(4):696-708. doi: 10.1037/ccp0000017. Epub 2015 Apr 13.
Results Reference
derived
PubMed Identifier
24938369
Citation
Smith SS, Fiore MC, Baker TB. Smoking cessation in smokers who smoke menthol and non-menthol cigarettes. Addiction. 2014 Dec;109(12):2107-17. doi: 10.1111/add.12661. Epub 2014 Jul 21.
Results Reference
derived
PubMed Identifier
24893290
Citation
Stein JH, Asthana A, Smith SS, Piper ME, Loh WY, Fiore MC, Baker TB. Smoking cessation and the risk of diabetes mellitus and impaired fasting glucose: three-year outcomes after a quit attempt. PLoS One. 2014 Jun 3;9(6):e98278. doi: 10.1371/journal.pone.0098278. eCollection 2014.
Results Reference
derived
PubMed Identifier
22496918
Citation
Johnson HM, Piper ME, Baker TB, Fiore MC, Stein JH. Effects of smoking and cessation on subclinical arterial disease: a substudy of a randomized controlled trial. PLoS One. 2012;7(4):e35332. doi: 10.1371/journal.pone.0035332. Epub 2012 Apr 9.
Results Reference
derived
PubMed Identifier
22172440
Citation
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. doi: 10.1016/j.ahj.2011.06.023. Epub 2011 Nov 14.
Results Reference
derived
PubMed Identifier
21885891
Citation
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. doi: 10.1123/jpah.8.7.994.
Results Reference
derived
PubMed Identifier
20236788
Citation
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. doi: 10.1016/j.jacc.2010.03.002. Epub 2010 Mar 17.
Results Reference
derived
Links:
URL
http://www.endcigs.com
Description
home page of agency performing the research
Learn more about this trial
Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms
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