The Effects of Nicotine Withdrawal on Reward Responsivity in Schizophrenia

NCT00373126 | Completed Phase 4

• 2 other identifiers: CORRC 06-052005P-001753
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

nicotine; schizophrenia; reward; withdrawal

Outcome Measures

Primary Outcomes (1)

• Reward Responsivity using a signal detection task

Secondary Outcomes (2)

• Cognitive drug research cognitive battery

• Source monitoring task to assess verbal memory

Interventions

transdermal nicotine patch DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• North Suffolk Mental Health Association: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Freedom Trail Clinic, 25 Staniford Street

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• A E Evins, MD MPH

  North Suffolk Mental Health Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 7, 2006
• Study Start: April 1, 2005
• Last Updated: May 15, 2009

Record last verified: 2009-05

Locations

US (1)