CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Nicotine polacrilex lozenge +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02069392
NCT02069392N/ACompleted

Nicotinic Enhancement of Cognitive Remediation Training in Schizophrenia

University of Maryland, Baltimore·interventional·Posted Feb 24, 2014·Updated Sep 12, 2019

In Brief

A clinical study evaluating Cognitive remediation training and Nicotine polacrilex lozenge for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2014
Enrollment StartJan 1, 2015
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.4 years ago

Interventions

Cognitive remediation trainingbehavioral

Nicotine polacrilex lozengedrug

Of interest are the effects of nicotine on cognitive remediation training benefits.