Status:
TERMINATED
Effects of Acute Nicotine Treatment on Neuroplasticity and Memory in Patients With Schizophrenia
Lead Sponsor:
Centre for Addiction and Mental Health
Conditions:
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Patients with schizophrenia display cognitive impairments, such as reduced attention and problems with memory. Available medications for schizophrenia poorly alleviate memory problems however, researc...
Detailed Description
Background: Schizophrenia (SCZ) is frequently associated with marked working memory (WM) deficits whose pathophysiology is closely related to dorsolateral prefrontal cortex (DLPFC)-dependent dysfuncti...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age of 18-55 years
- Non-smoker or past smoker, abstinent for at least the last 1 year, non-smoking status will be assessed on the test days by saliva cotinine levels \<15ng/mL and exhalation CO levels \<10ppm.
- Females with potential childbearing must have a negative urine pregnancy test at inclusion.
- Women with child-bearing potential must use contraceptives during the trial Acceptable means of contraception are hormonal methods (pill, injection, vaginal ring), male or female condom, abstinence, injectable contraceptives, intrauterine devices or abstinence.
- Ability and willingness to speak English
- Willingness to provide informed consent
- Adequate hearing and visual capacity, or corrected by visual/ hearing aid • Right handedness
- Patients with schizophrenia:
- Current diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV TR criteria
- Stable antipsychotic treatment or dosage for the past 4 weeks prior to study entry
- Clinically stable, i.e. no psychotic episode that required hospitalization within the last 3 months prior to study inclusion
- Exclusion Criteria:
- General
- Current smoker or abstinent smoker for less than 1 year
- Past or current history of drug abuse disorder or current elicit drug use, positive urine drug screen (for any other drug besides benzodiazepines) on any of the two test days
- Current or past history of neurological disorder, i.e. meets criteria for a cognitive disorder secondary to a neurological or other medical disorder affecting the central nervous system (such as, traumatic brain injury, stroke, Parkinson).
- Current or past history of seizures
- Any metal implants
- Mini Mental Status Examination score of ≤17
- Diagnosis of bipolar disorder or current major depressive episode
- Electroconvulsive Therapy (ECT) within 6 months prior to study participation
- Allergy to any of the following: nicotine resin, xylitol, butylhydroxythyolen E 321, sodium carbonate, corn starch, magnesium oxide, D\&C Yellow No 10, menthol, acesulfam potassium, wax, titan oxide, maltitol, sorbitol, gum base, sucralose, palm oil, mannitol, glycerin, calcium carbonate, gum arabic.
- Any of the following; breast feeding, immediate post-myocardial infarction period, life-threatening arrhythmias, angina pectoris, and active temporomandibular joint disease, oral or pharyngeal inflammation, or history of esophagitis or peptic ulcer.
- Healthy controls:
- Any psychiatric diagnosis except for simple phobias or an adjustment disorder as diagnosed by DSM IV TR
- Psychotropic medication (except for sedative /hypnotics at a stable dose for at least 4 weeks).
- Sedative /hypnotics at a stable dose less than 4 weeks
- A first-degree relative with as past or present history of primary psychotic disorder
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01465074
Start Date
November 1 2011
End Date
April 1 2013
Last Update
August 13 2013
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8