Effects of Acute Nicotine Treatment on Neuroplasticity and Memory in Patients With Schizophrenia (NIC-PAS)
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|ClinicalTrials.gov Identifier: NCT01465074|
Recruitment Status : Terminated (Limited staff and operating resources)
First Posted : November 4, 2011
Last Update Posted : August 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Nicotine polacrilex Drug: Regular chewing gum; Dentyne Ice, Wrigely´s Mint Gum||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Acute Nicotine on Long-term Potentiation in the Dorsolateral Prefrontal Cortex of Patients With Schizophrenia and Healthy Controls|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Active Comparator: Nicotine gum (4 mg)
Nicotine gum will be given once on one of the two test days in a randomized, double-blinded fashion. Gum will be chewed for 30 min before the plasticity induction occurs.
Drug: Nicotine polacrilex
Other Name: Nicorette, Extreme Chill
Placebo Comparator: Regular Mint Gum
Regular, taste-, texture- and color matched with the Nicotine Gum will be ingested once on one of the two testing days, 30 min before plasticity induction.
Drug: Regular chewing gum; Dentyne Ice, Wrigely´s Mint Gum
30 min chewing, one dose
- Change in prefrontocortical neuroplasticity [ Time Frame: 0, 15, 30, 60, 120 min, 7 days post treatment ]Change in cortical evoked activity (using EEG) from baseline to the different time points following paired associative stimulation.
- Change in working memory [ Time Frame: baseline, 30 and 120 min and 7 days post treatment ]
N-back performance can be assessed in four conditions, where 0-back is the control condition in which the test subject responds to every letter that appears on the screen, making sure the person can respond to the stimuli as it requires no on-line retention of information. The 1, 2 and 3 back conditions assess on-line retention with increasing difficulty. Average performance, i.e. number of accurate responses as well as response time, will be used as outcome measures.
PAS-NBACK=(Average performance Post-PAS/ Average performance at baseline)*100
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 ClinicalTrials.gov identifier (NCT number): NCT01465074
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M5T 1R8|
|Principal Investigator:||Tony P George, M.D.||Centre for Addiction and Mental Health, Schizophrenia Program, Toronto, ON, Canada|
|Principal Investigator:||Jeff Z Daskalakis, M.D., Ph.D.||Centre for Addiction and Mental Health, Brain Stimulation Lab, Toronto, ON, Canada|