The Effects of Nicotine Withdrawal on Reward Responsivity in Schizophrenia
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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 |
- Reward Responsivity using a signal detection task
- 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 |
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| United States, Massachusetts | |
| Freedom Trail Clinic, 25 Staniford Street | |
| Boston, Massachusetts, United States, 02114 | |
| 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:
|
Substance Withdrawal Syndrome Psychotic Disorders Schizophrenia Substance-Related Disorders Mental Disorders Schizophrenia and Disorders with Psychotic Features Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013