NCT00063323

Brief Summary

The purpose of this study is to determine the efficacy and cost-effectiveness of long-term pharmacotherapy (using Zyban and/or nicotine replacement) for reducing the relapse rate associated with stopping smoking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
589

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2000

Longer than P75 for phase_3

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

August 1, 2000

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2003

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2010

Enrollment Period

5.9 years

First QC Date

June 25, 2003

Last Update Submit

January 11, 2017

Conditions

Tobacco Use Disorder

Keywords

Maintenance treatmentSmoking relapseBupropionNicotine replacement

Outcome Measures

Primary Outcomes (1)

  • Survival abstinence rate with maintenance treatment

    48 weeks after start of treatment

Study Arms (4)

Bupropion

ACTIVE COMPARATOR

Bupropion (brand name Zyban Sustained Release). Participants used bupropion SR 150 mg twice daily during the 16-week maintenance treatment.

Drug: Bupropion

Nicotine gum

ACTIVE COMPARATOR

Nicotine gum (brand name Nicorette) During the maintenance 16-week maintenance treatment phase, participants assigned to this arm received 2 mg. nicotine gum.

Drug: Bupropion

Bupropion+Nicotine Gum

ACTIVE COMPARATOR

Combined active treatments: Bupropion (Zyban SR) and nicotine gum (Nicorette). Participants were instructed to use the 150 mg bupropion pill twice daily and the 2 mg. gum as needed during the 16-week maintenance treatment phase.

Drug: Bupropion

Double placebo

PLACEBO COMPARATOR

Placebo gum + placebo pill. Identical placebo pill was used twice daily and identical placebo gum was used as needed.

Drug: Bupropion

Interventions

BupropionDRUG
BupropionBupropion+Nicotine GumDouble placeboNicotine gum

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who smoke at least 10 cigarettes daily and have attempted to quit smoking at least once

You may not qualify if:

  • Seizure History
  • Unstable Blood Pressure
  • Current major depression
  • Current alcohol/drug abuse or dependency
  • Lifetime psychotic illness
  • Current use of psychotropic drugs
  • Unstable medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (5)

  • Covey LS, Glassman AH, Jiang H, Fried J, Masmela J, LoDuca C, Petkova E, Rodriguez K. A randomized trial of bupropion and/or nicotine gum as maintenance treatment for preventing smoking relapse. Addiction. 2007 Aug;102(8):1292-302. doi: 10.1111/j.1360-0443.2007.01887.x.

    PMID: 17624979RESULT

  • Covey LS, Botello-Harbaum M, Glassman AH, Masmela J, LoDuca C, Salzman V, Fried J. Smokers' response to combination bupropion, nicotine patch, and counseling treatment by race/ethnicity. Ethn Dis. 2008 Winter;18(1):59-64.

    PMID: 18447101RESULT

  • Covey LS, Manubay J, Jiang H, Nortick M, Palumbo D. Smoking cessation and inattention or hyperactivity/impulsivity: a post hoc analysis. Nicotine Tob Res. 2008 Dec;10(12):1717-25. doi: 10.1080/14622200802443536.

    PMID: 19023824RESULT

  • Covey LS, Weissman J, LoDuca C, Duan N. A comparison of abstinence outcomes among gay/bisexual and heterosexual male smokers in an intensive, non-tailored smoking cessation study. Nicotine Tob Res. 2009 Nov;11(11):1374-7. doi: 10.1093/ntr/ntp137. Epub 2009 Sep 24.

    PMID: 19778993RESULT

  • 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 Disorder

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Lirio S. S Covey, Ph.D.

    Research Foundation for Mental Hygiene, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 25, 2003

First Posted

July 1, 2003

Study Start

August 1, 2000

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

January 12, 2017

Record last verified: 2010-01

Locations

US(1)