NCT02069392

Nicotinic Enhancement of Cognitive Remediation Training in Schizophrenia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Schizophrenia is marked by problems in attention, memory and problem solving. These deficits predict long-term functional outcome such as the ability to live independently and maintain employment, but they are not ameliorated by currently available medications. Cognitive training improves these functions to some degree, but this approach is time- and resource-intensive. The current project aims at enhancing and accelerating the benefits that people with schizophrenia derive from cognitive training by administering nicotine during some of the training sessions. This would provide the proof of principle for a type of treatment intervention to improve cognitive symptoms of schizophrenia. The current project aims at determining whether the intermittent presence of nicotine during cognitive training exercises in people with schizophrenia will shorten the training period necessary to induce significant and clinically relevant improvement and enhance the improvement seen after a training period of specified length. Hypothesis 1a: Nicotine administration during training will increase the size of all measured effects of the training intervention, and will accelerate the time course of performance enhancement on the MCCB and training exercise progression parameters. Hypothesis 1b: The larger training effects in the Nicotine Group will persist beyond the end of the intervention. Hypothesis 2a: Within-session progress on the training exercises will be larger in the presence of nicotine than in the presence of placebo. Hypothesis 2b: These acute nicotine-induced performance elevations will persist beyond the presence of nicotine through subsequent non-drug training sessions, giving evidence of an acute facilitation of learning processes.

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive remediation training
DRUG	Nicotine polacrilex lozenge	Of interest are the effects of nicotine on cognitive remediation training benefits.

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2014-02-24
• Last updated: 2019-09-12
• Results posted: 2019-04-08

Locations

1 site across 1 country: United States