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The Effects of Nicotine Withdrawal on Reward Responsivity in Schizophrenia

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. Identifier: NCT00373126
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : May 15, 2009
Massachusetts General Hospital
Information provided by:
North Suffolk Mental Health Association

Brief Summary:
It has been suggested that patients with schizophrenia smoke in order to produce amelioration of dysfunctional dopaminergic pathways allowing them to experience pleasure and satisfaction and overcome anhedonia. No studies have assessed the effects of nicotine withdrawal on reward responsivity in patients with schizophrenia. The investigators believe that an understanding of this is crucial if improved treatments for nicotine dependence are to be developed for this patient population. If this group already has deficits in reward responsivity as a symptom of the disease then they may be particularly prone to the effects of nicotine withdrawal on reward systems. Smoking cessation may lead to a further decrease in their responsivity to pleasurable stimuli and worsening anhedonia. Treatments for smoking cessation may need to ameliorate any increased deficits if they are likely to be effective in patients with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: transdermal nicotine patch Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Trial of Reward Responsivity During Nicotine Withdrawal in Smokers With Schizophrenia and Normal Controls
Study Start Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Primary Outcome Measures :
  1. Reward Responsivity using a signal detection task

Secondary Outcome Measures :
  1. Cognitive drug research cognitive battery
  2. Source monitoring task to assess verbal memory

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Schizophrenia group inclusion criteria:

  • DSM IV diagnosis of schizophrenia with stable symptoms and a stable dose of antipsychotic medications for at least 4 weeks
  • Age 18-55 inclusive
  • Able to provide informed consent
  • Self reported smoking of 20 or more cigarettes per day for at least 12 months
  • FTND score of >/= 5
  • Expired air CO of >/= 10 ppm
  • WRAT-3 IQ score greater than or equal to 35
  • Normal or corrected to normal vision

Control group inclusion criteria: Same as above except for diagnosis of schizophrenia

Exclusion Criteria:

Schizophrenia Group exclusion criteria:

  • Current unstable serious medical illness such as uncontrolled high blood pressure, untreated ischemic heart disease
  • Use of any cholinesterase inhibitor such as galantamine in the past 3 months
  • History of skin diseases (e.g., psoriasis), skin allergies, or strong reactions to topical preparations, medical dressings, tapes or nicotine patches
  • Treated with an investigational medication in the last 30 days
  • Currently or planning to become pregnant in the next 8 weeks as verified by positive pregnancy test or childbearing potential and not using adequate contraception
  • Substance abuse in the past month: Self reported or diagnosed during chart review and verified by positive salivary test for cocaine, methamphetamine, amphetamine, ethanol, THC, opiates or PCP at screen
  • Current major depressive disorder
  • History of cognitive impairment due to other disorders such as head injury, dementia, general medical condition
  • Diagnosis of mental retardation

Control group exclusion criteria: Same as above except for diagnosis of schizophrenia or family history of psychiatric illness

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 identifier (NCT number): NCT00373126

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United States, Massachusetts
Freedom Trail Clinic, 25 Staniford Street
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
North Suffolk Mental Health Association
Massachusetts General Hospital
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Principal Investigator: A E Evins, MD MPH North Suffolk Mental Health Association

Layout table for additonal information Identifier: NCT00373126     History of Changes
Other Study ID Numbers: CORRC 06-05
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: May 2009
Keywords provided by North Suffolk Mental Health Association:
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
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