NCT01621022

Brief Summary

Focus of this study was to determine if bupropion was more effective for smoking cessation when used alone or combined with nicotine gum.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
608

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2001

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

January 1, 2001

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

June 13, 2012

Last Update Submit

December 5, 2016

Conditions

Tobacco Dependence

Keywords

smoking cessationtobacco dependence

Outcome Measures

Primary Outcomes (1)

  • 7-day point prevalence abstinence measured at 6 months

    No smoking, not evan a puff, during the 7 days prior to the 6 month follow-up

    6 months

Study Arms (3)

Active bupropion-Active gum

ACTIVE COMPARATOR

150 mg bupropion twice daily + 4 mg nicotine gum as needed (up to 12 pcs/day)

Drug: bupropion + nicotine gum

Active bupropion-Placebo gum

ACTIVE COMPARATOR

150mg bupropion twice daily + placebo gum as needed (up to 12 pcs/day)

Drug: Active bupropion-Placebo gum

Placebo medication-Placebo gum

ACTIVE COMPARATOR

Placebo bupropion, twice daily, plus placebo gum as needed (up to 12 pcs/day)

Drug: Placebo bupropion-Placebo gum

Interventions

bupropion + nicotine gumDRUG

150 mg bupropion twice daily plus 4 mg nicotine gum as needed (up to 12 pcs/day)

Active bupropion-Active gum
Active bupropion-Placebo gumDRUG

150mg bupropion twice daily plus placebo nicotine gum as needed (up to 12 pcs/day)

Active bupropion-Placebo gum
Placebo bupropion-Placebo gumDRUG

Placebo bupropion twice daily + placebo nicotine gum as needed (up to 12 pcs/day)

Placebo medication-Placebo gum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoke 10 or more cigarettes per day
  • Motivated to quit
  • No physical or mental health issues that would prevent participation
  • Not pregnant or willing to prevent pregnancy during treatment

You may not qualify if:

  • Carbon monoxide (CO) breath test score below 10 parts per million (ppm)
  • Center for Epidemiologic Studies Depression Scale (CES-D) score greater than 16
  • Heavy alcohol use
  • History of eating disorder
  • Suicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW Center for Tobacco Research and Intervention

Madison, Wisconsin, 53711, United States

Location

Related Publications (2)

  • Piper ME, Federman EB, McCarthy DE, Bolt DM, Smith SS, Fiore MC, Baker TB. Efficacy of bupropion alone and in combination with nicotine gum. Nicotine Tob Res. 2007 Sep;9(9):947-54. doi: 10.1080/14622200701540820.

    PMID: 17763111RESULT

  • 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: 37230961DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderSmoking Cessation

Interventions

BupropionNicotine Chewing Gum

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic ChemicalsChewing GumPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesTobacco Use Cessation DevicesTherapeuticsCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2012

First Posted

June 15, 2012

Study Start

January 1, 2001

Primary Completion

October 1, 2002

Study Completion

October 1, 2002

Last Updated

December 6, 2016

Record last verified: 2016-12

Locations

US(1)