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Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

NCT ID: NCT00332644

Last Updated: 2011-11-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2010-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

nicotine patch alone treatment

Group Type EXPERIMENTAL

nicotine patch

Intervention Type DRUG

used according to FDA package label

2

nicotine lozenge alone treatment

Group Type EXPERIMENTAL

nicotine lozenge

Intervention Type DRUG

used according to FDA-approved package directions

3

nicotine patch + lozenge combination treatment

Group Type EXPERIMENTAL

nicotine patch + nicotine lozenge

Intervention Type DRUG

dosage of both according to FDA-approved dosing schedule

4

bupropion alone treatment

Group Type EXPERIMENTAL

bupropion

Intervention Type DRUG

dosage according to FDA-approved instructions

5

bupropion + nicotine lozenge combination treatment

Group Type EXPERIMENTAL

bupropion + lozenge

Intervention Type DRUG

dosage according to FDA approved standard instructions

6

placebo control (no active medication) treatment

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

dosage same as active drug conditions

Interventions

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nicotine patch

used according to FDA package label

Intervention Type DRUG

nicotine lozenge

used according to FDA-approved package directions

Intervention Type DRUG

nicotine patch + nicotine lozenge

dosage of both according to FDA-approved dosing schedule

Intervention Type DRUG

bupropion

dosage according to FDA-approved instructions

Intervention Type DRUG

bupropion + lozenge

dosage according to FDA approved standard instructions

Intervention Type DRUG

placebo

dosage same as active drug conditions

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy B. Baker, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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UW-CTRI Madison Research site

Madison, Wisconsin, United States

Site Status

UW-CTRI Milwaukee Research site

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.

Reference Type DERIVED
PMID: 37335995 (View on PubMed)

Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

Reference Type DERIVED
PMID: 37230961 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29251951 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25867447 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24938369 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24893290 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22496918 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22172440 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21885891 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20236788 (View on PubMed)

Related Links

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http://www.endcigs.com

home page of agency performing the research

Other Identifiers

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P50DA019706

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P50DA19706-1

Identifier Type: -

Identifier Source: org_study_id

NCT00109447

Identifier Type: -

Identifier Source: nct_alias