Effects of Acute Nicotine Treatment on Neuroplasticity and Memory in Patients With Schizophrenia (NIC-PAS)
|Schizophrenia||Drug: Nicotine polacrilex Drug: Regular chewing gum; Dentyne Ice, Wrigely´s Mint Gum|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (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|
- 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
|Study Start Date:||November 2011|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
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
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: 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|