The Effects of Nicotine Withdrawal on Reward Responsivity in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by:
North Suffolk Mental Health Association
ClinicalTrials.gov Identifier:
NCT00373126
First received: September 5, 2006
Last updated: May 14, 2009
Last verified: May 2009
  Purpose

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 Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: transdermal nicotine patch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Trial of Reward Responsivity During Nicotine Withdrawal in Smokers With Schizophrenia and Normal Controls

Resource links provided by NLM:


Further study details as provided by North Suffolk Mental Health Association:

Primary Outcome Measures:
  • Reward Responsivity using a signal detection task

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

Estimated Enrollment: 40
Study Start Date: April 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373126

Locations
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
Investigators
Principal Investigator: A E Evins, MD MPH North Suffolk Mental Health Association
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00373126     History of Changes
Other Study ID Numbers: CORRC 06-05, 2005P-001753
Study First Received: September 5, 2006
Last Updated: May 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by North Suffolk Mental Health Association:
nicotine
schizophrenia
reward
withdrawal

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014