Treating Nicotine Dependence in Schizophrenic Individuals: Effectiveness of Bupropion - 1

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00124683
First received: July 26, 2005
Last updated: August 1, 2007
Last verified: August 2007

July 26, 2005
August 1, 2007
September 2001
Not Provided
7 day point prevalence of cigarette abstinence [ Time Frame: End of trial (week 10) ]
7 day point prevalence of cigarette abstinence
Complete list of historical versions of study NCT00124683 on ClinicalTrials.gov Archive Site
  • Craving [ Time Frame: assessed weekly ]
  • Medication compliance [ Time Frame: assessed weekly ]
  • Depression [ Time Frame: assessed at weeks 1, 4, 7, 10 and at six-month followup ]
  • Withdrawal symptoms [ Time Frame: assessed weekly and at six month followup ]
  • Schizophrenic symptoms [ Time Frame: assessed at weeks 1, 4, 7, 10 and at six-month followup ]
  • Craving
  • Medication compliance
  • Depression
  • Withdrawal symptoms
  • Schizophrenic symptoms
Not Provided
Not Provided
 
Treating Nicotine Dependence in Schizophrenic Individuals: Effectiveness of Bupropion - 1
Optimizing Treatment for Schizophrenic Smokers

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.

Past research on the use of the NTP, atypical antipsychotics, and bupropion in schizophrenic individuals to aid in smoking cessation has been encouraging. The purpose of this study is to compare bupropion SR to a placebo to determine its effectiveness when used in combination with an NTP to help schizophrenic individuals quit smoking.

Participants in this double-blind, placebo-controlled study will be randomly assigned to receive either the NTP (21 mg/day) and placebo or the NTP and bupropion SR (300 mg/day). Participants will begin taking one pill each day of bupropion SR (150 mg/day) or placebo at the start of the second week of the study. After three days, the dose of bupropion SR or placebo will increase to 2 pills each day. Participants will continue this dosing regimen until the end of Week 10. Throughout the 10-week study, participants will receive weekly group therapy.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Tobacco Use Cessation
  • Tobacco Use Disorder
  • Schizophrenia
  • Drug: Bupropion
  • Drug: nicotine transdermal patch
  • Experimental: 1
    Nicotine Patch + Bupropion
    Interventions:
    • Drug: Bupropion
    • Drug: nicotine transdermal patch
  • Placebo Comparator: 2
    Nicotine patch + placebo
    Intervention: Drug: nicotine transdermal patch
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. Epub 2007 Dec 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
May 2007
Not Provided

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00124683
NIDA-13672-1, R01-13672-1, DPMC
Yes
Not Provided
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Tony P George, M.D. Yale University
National Institute on Drug Abuse (NIDA)
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP