ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00124683
Recruitment Status : Completed
First Posted : July 28, 2005
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Tobacco Use Disorder Schizophrenia Drug: Bupropion Drug: nicotine transdermal patch Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Optimizing Treatment for Schizophrenic Smokers
Study Start Date : September 2001
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Nicotine Patch + Bupropion
Drug: Bupropion
Drug: nicotine transdermal patch
Placebo Comparator: 2
Nicotine patch + placebo
Drug: nicotine transdermal patch



Primary Outcome Measures :
  1. 7 day point prevalence of cigarette abstinence [ Time Frame: End of trial (week 10) ]

Secondary Outcome Measures :
  1. Craving [ Time Frame: assessed weekly ]
  2. Medication compliance [ Time Frame: assessed weekly ]
  3. Depression [ Time Frame: assessed at weeks 1, 4, 7, 10 and at six-month followup ]
  4. Withdrawal symptoms [ Time Frame: assessed weekly and at six month followup ]
  5. Schizophrenic symptoms [ Time Frame: assessed at weeks 1, 4, 7, 10 and at six-month followup ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124683


Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Tony P George, M.D. Yale University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00124683     History of Changes
Other Study ID Numbers: NIDA-13672-1
R01-13672-1
DPMC
First Posted: July 28, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: August 2007

Keywords provided by National Institute on Drug Abuse (NIDA):
nicotine dependence

Additional relevant MeSH terms:
Schizophrenia
Tobacco Use Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Nicotine
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors