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Nicotine DependencePhase 4NCT00332644

Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

A Phase 4 study testing nicotine patch, nicotine lozenge and nicotine patch + nicotine lozenge in people with Nicotine Dependence, run by University of Wisconsin, Madison at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Nicotine Dependence
What is being tested?
nicotine patch, nicotine lozenge and nicotine patch + nicotine lozenge
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,504 participants
Where
2 sitesUnited States
Study dates
Sep 2004to Aug 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UW-CTRI Madison Research site

    Madison, Wisconsin, 53711

  • UW-CTRI Milwaukee Research site

    Milwaukee, Wisconsin, 53233

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
nicotine patch, nicotine lozenge, nicotine patch + nicotine lozenge, bupropion, bupropion + lozenge
Medical subject headings
Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nicotine patchDrug

    used according to FDA package label

  • nicotine lozengeDrug

    used according to FDA-approved package directions

  • nicotine patch + nicotine lozengeDrug

    dosage of both according to FDA-approved dosing schedule

  • bupropionDrug

    dosage according to FDA-approved instructions

  • bupropion + lozengeDrug

    dosage according to FDA approved standard instructions

  • placeboDrug

    dosage same as active drug conditions

Study groups in NCT00332644
Study groupRoleWhat they receive
1Experimentalnicotine patch alone treatment
Receives: Drug: nicotine patch
2Experimentalnicotine lozenge alone treatment
Receives: Drug: nicotine lozenge
3Experimentalnicotine patch + lozenge combination treatment
Receives: Drug: nicotine patch + nicotine lozenge
4Experimentalbupropion alone treatment
Receives: Drug: bupropion
5Experimentalbupropion + nicotine lozenge combination treatment
Receives: Drug: bupropion + lozenge
6Placebo comparatorplacebo control (no active medication) treatment
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6 months post quit date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2006 (estimated)
  2. Study startSep 2004
  3. Primary completionAug 2010
  4. Study completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,504 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00332644
Sponsor's protocol ID
P50DA19706-1
Other IDs
P50DA019706
Status last verified
Oct 2011
First submitted
1 Jun 2006
Last updated
30 Nov 2011
Data monitoring committee
No

Publications

  • 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.

    PubMed 37335995

  • 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.

    PubMed 37230961

  • 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.

    PubMed 29251951

  • 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.

    PubMed 25867447

  • 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.

    PubMed 24938369

  • 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.

    PubMed 24893290

  • 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.

    PubMed 22496918

  • 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.

    PubMed 22172440

  • 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.

    PubMed 21885891

  • 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.

    PubMed 20236788

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing nicotine patch, nicotine lozenge and nicotine patch + nicotine lozenge in people with Nicotine Dependence, run by University of Wisconsin, Madison at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (time frame: 6 months post quit date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00332644, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2011.

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