NCT00296647

Brief Summary

The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,346

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
12 months until next milestone

Results Posted

Study results publicly available

November 30, 2011

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

4.8 years

First QC Date

February 24, 2006

Results QC Date

October 21, 2011

Last Update Submit

October 9, 2015

Conditions

Tobacco Dependence

Outcome Measures

Primary Outcomes (1)

  • 6 Month Self-reported Abstinence From Smoking

    Primary postquit outcomes was 7-day point prevalence abstinence (0, abstinent; 1, smoking) at 6 months (based on the week 24 interview)

    6 months

Study Arms (5)

patch

ACTIVE COMPARATOR
Drug: nicotine patch

nicotine lozenge

ACTIVE COMPARATOR
Drug: nicotine lozenge

bupropion

ACTIVE COMPARATOR
Drug: bupropion

patch + lozenge

ACTIVE COMPARATOR
Drug: patch + lozenge

buproion + lozenge

ACTIVE COMPARATOR
Drug: bupropion + lozenge

Interventions

nicotine patchDRUG

Decreasing dosages from 21 to 7 mg over 12 week period

patch
nicotine lozengeDRUG

4 mg nicotine lozenge: dosage according to package directions for 16 weeks

nicotine lozenge
bupropionDRUG

dosage according to prescription directions: 12 weeks

bupropion
patch + lozengeDRUG

dosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge)

patch + lozenge
bupropion + lozengeDRUG

dosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge)

buproion + lozenge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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, Aurora participating clinic patient

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW-CTRI Milwaukee Research site

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (2)

  • Hockenberry JM, Curry SJ, Fishman PA, Baker TB, Fraser DL, Cisler RA, Jackson TC, Fiore MC. Healthcare costs around the time of smoking cessation. Am J Prev Med. 2012 Jun;42(6):596-601. doi: 10.1016/j.amepre.2012.02.019.

    PMID: 22608375DERIVED

  • Smith SS, McCarthy DE, Japuntich SJ, Christiansen B, Piper ME, Jorenby DE, Fraser DL, Fiore MC, Baker TB, Jackson TC. Comparative effectiveness of 5 smoking cessation pharmacotherapies in primary care clinics. Arch Intern Med. 2009 Dec 14;169(22):2148-55. doi: 10.1001/archinternmed.2009.426.

    PMID: 20008701DERIVED

Related Links

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Use Cessation DevicesBupropionTransdermal Patch

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsPropiophenonesKetonesOrganic ChemicalsEquipment and Supplies

Limitations and Caveats

The present study is limited to some extent by the fact that self-reported abstinence was not biochemically confirmed. However, there is evidence that self-reported abstinence rates are generally accurate in low-contact effectiveness studies.

Results Point of Contact

Title
Stevens Smith, PhD
Organization
UW-Center for Tobacco Research and Intervention
sss@ctri.medicine.wisc.edu
608-262-7563

Study Officials

  • Thomas C Jackson, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2006

First Posted

February 27, 2006

Study Start

September 1, 2004

Primary Completion

July 1, 2009

Study Completion

December 1, 2010

Last Updated

October 14, 2015

Results First Posted

November 30, 2011

Record last verified: 2015-10

Locations

US(1)