NCT01186471

The Effect of Nicotine on Arousal, Cognition and Social Cognition in Schizophrenic Patients

A Double-Blind, Placebo-Controlled, Randomized Three-Way Crossover Study to Investigate The Effect of Nicotine on Arousal, Standard Cognitive Tasks And Social Cognition in Patients With Schizophrenia (Smoking and Non-Smoking)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Janssen Pharmaceutica N.V., Belgium · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study in patients with stable schizophrenia will investigate the effect of nicotine on arousal, cognitive task and social cognition after acute dose administration.

Detailed description

This is a double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled, randomized (study drug assigned by chance), three-way-crossover trial (patients may receive different interventions sequentially during the trial) in patients with stable schizophrenia. The three-way-crossover treatment phase will consist of three blinded treatment periods separated by a wash out period (the period allowed for the entire administered drug to be eliminated from the body) of 2 to 7 days. The study duration for each patient will be approximately 8 weeks. Each patient enrolled will be randomized to receive Treatment A (1mg nicotine per dosing), Treatment B (2mg nicotine per dosing) or Treatment C (placebo) during one of their treatment period. The study drug (nicotine or placebo) will be administered three times daily on Day 1 of each treatment phase as a mouth spray, separated 2 to 3 hours from each other (i.e. 0h; and 2 to 3h; and 4 to 6h post first dosing). Three different blocks of cognitive assessments will follow, one after each drug administration. Safety evaluations include adverse event monitoring, vital signs and clinical laboratory tests. Each patient participating will receive 3 identical study drug administrations per dosing day (2 to 3 hours from each other), resulting in an overall dose of 3 mg nicotine (Treatment A), 6 mg nicotine (Treatment B) or 0 mg nicotine (Treatment C) per dosing day. By the end of the study, after the 3-way crossover, each patient will have received 9 mg nicotine via mouth spray.

Conditions

• Schizophrenia
• Cognition Disorders

Interventions

Type	Name	Description
OTHER	A643 (nicotine)	1mg oromucosal nicotine spray- three times daily during each treatment period
OTHER	A643 (nicotine)	2mg oromucosal nicotine spray- three times daily during each treatment period
DRUG	placebo	placebo - three times daily during each treatment period

Timeline

• Start date: 2010-05-01
• Completion: 2011-03-01
• First posted: 2010-08-23
• Last updated: 2012-03-20