Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

NCT00332644 | Completed Phase 4 Results

• 2 other identifiers: P50DA19706-1P50DA019706
• Study Type: interventional
• Target: 1,504
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (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).

  6 months post quit date

Study Arms (6)

1

EXPERIMENTAL

nicotine patch alone treatment

Drug: nicotine patch

2

EXPERIMENTAL

nicotine lozenge alone treatment

Drug: nicotine lozenge

3

EXPERIMENTAL

nicotine patch + lozenge combination treatment

Drug: nicotine patch + nicotine lozenge

4

EXPERIMENTAL

bupropion alone treatment

Drug: bupropion

5

EXPERIMENTAL

bupropion + nicotine lozenge combination treatment

Drug: bupropion + lozenge

6

PLACEBO COMPARATOR

placebo control (no active medication) treatment

Drug: placebo

Interventions

nicotine patch DRUG

used according to FDA package label

1

nicotine lozenge DRUG

used according to FDA-approved package directions

2

nicotine patch + nicotine lozenge DRUG

dosage of both according to FDA-approved dosing schedule

3

bupropion DRUG

dosage according to FDA-approved instructions

4

bupropion + lozenge DRUG

dosage according to FDA approved standard instructions

5

placebo DRUG

dosage same as active drug conditions

6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

UW-CTRI Madison Research site

Madison, Wisconsin, 53711, United States

Location

UW-CTRI Milwaukee Research site

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (10)

• 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.

  PMID: 37335995 DERIVED

• 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.

  PMID: 37230961 DERIVED

• 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.

  PMID: 29251951 DERIVED

• 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.

  PMID: 25867447 DERIVED

• 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.

  PMID: 24938369 DERIVED

• 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.

  PMID: 24893290 DERIVED

• 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.

  PMID: 22496918 DERIVED

• 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.

  PMID: 22172440 DERIVED

• 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.

  PMID: 21885891 DERIVED

• 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.

  PMID: 20236788 DERIVED

Related Links

• home page of agency performing the research

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices; Bupropion

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Piper, Megan E
• Organization: University of Wisconsin

mep@ctri.medicine.wisc.edu

608-265-5472

Study Officials

• Timothy B. Baker, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2006
• First Posted: June 2, 2006
• Study Start: September 1, 2004
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 30, 2011
• Results First Posted: November 30, 2011

Record last verified: 2011-10

Locations

US (2)