NCT00124683

Brief Summary

Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. In addition, this study will evaluate how the combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_2

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, 2001

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

January 12, 2017

Status Verified

August 1, 2007

First QC Date

July 26, 2005

Last Update Submit

January 11, 2017

Conditions

Tobacco Use CessationTobacco Use DisorderSchizophrenia

Keywords

nicotine dependence

Outcome Measures

Primary Outcomes (1)

  • 7 day point prevalence of cigarette abstinence

    End of trial (week 10)

Secondary Outcomes (5)

  • Craving

    assessed weekly

  • Medication compliance

    assessed weekly

  • Depression

    assessed at weeks 1, 4, 7, 10 and at six-month followup

  • Withdrawal symptoms

    assessed weekly and at six month followup

  • Schizophrenic symptoms

    assessed at weeks 1, 4, 7, 10 and at six-month followup

Study Arms (2)

1

EXPERIMENTAL

Nicotine Patch + Bupropion

Drug: BupropionDrug: nicotine transdermal patch

2

PLACEBO COMPARATOR

Nicotine patch + placebo

Drug: nicotine transdermal patch

Interventions

BupropionDRUG
1
nicotine transdermal patchDRUG
12

Eligibility Criteria

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

You may qualify if:

  • DSM-IV diagnosis of schizophrenia or schizoaffective disorder and nicotine dependence
  • Fagerstrom Test for Nicotine Dependence (FTND) score greater than 5
  • Smokes at least 20 cigarettes per day (1 pack per day)
  • Expired breath CO level \> 10 ppm and cotinine level \> 210 ng/ml at the baseline measurement
  • Currently taking a stable dose of antipsychotic
  • Complete remission from positive symptoms of psychosis as judged by a psychiatric evaluation

You may not qualify if:

  • Meets criteria for current abuse or dependence for any alcohol or illicit substance within the past month
  • History of hypersensitivity to bupropion or the nicotine transdermal patch (NTP)
  • Current diagnosis of a serious documented medical disorder that would make bupropion treatment risky OR results of psychiatric/medical screening that suggest a reason for concern (e.g., a history of severe heart, liver, or kidney disease or diabetes mellitus)
  • Currently taking monoamine oxidase inhibitors or bupropion (Zyban or Wellbutrin)
  • Currently taking diabetes mellitus medications, St. John's Wort, appetite suppressants, ephedrine-containing medications, theophylline, clonidine, reserpine, methyldopa, or anti-anginal medications (e.g., beta-blockers, calcium channel blockers, nitroglycerin preparations)
  • History of schizoaffective disorder and not stabilized on a mood stabilizer (e.g., lithium, valproate, carbamazepine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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

  • George TP, Vessicchio JC, Sacco KA, Weinberger AH, Dudas MM, Allen TM, Creeden CL, Potenza MN, Feingold A, Jatlow PI. A placebo-controlled trial of bupropion combined with nicotine patch for smoking cessation in schizophrenia. Biol Psychiatry. 2008 Jun 1;63(11):1092-6. doi: 10.1016/j.biopsych.2007.11.002. Epub 2007 Dec 21.

    PMID: 18096137DERIVED

MeSH Terms

Conditions

Tobacco Use CessationTobacco Use DisorderSchizophrenia

Interventions

BupropionTobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic ChemicalsTherapeutics

Study Officials

  • Tony P George, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 26, 2005

First Posted

July 28, 2005

Study Start

September 1, 2001

Study Completion

May 1, 2007

Last Updated

January 12, 2017

Record last verified: 2007-08