Nicotinic Enhancement of Cognitive Remediation Training in Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 8/9/2017 |
| Start Date: | January 2015 |
| End Date: | June 2017 |
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.
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.
Inclusion Criteria:
- Aged 18-60 years.
- DSM diagnosis of schizophrenia or schizoaffective disorder.
- Ability to give written informed consent.
- Either currently smoking and not attempting to quit, or having smoked no more than 80
cigarettes, cigarillos or cigars in lifetime and not at all within the last year.
- Normal or corrected to normal vision (at least 20/50).
- Four weeks of stable pharmacological treatment (same psychiatric medication at same
dose) and no foreseeable changes at enrollment.
Exclusion Criteria:
- Alcohol or substance abuse or dependence other than nicotine within the last 12
months.
- Uncontrolled hypertension (resting systolic blood pressure above 150 or diastolic
above 90 mm Hg).
- History of myocardial infarction, heart failure, angina, stroke or severe arrhythmias.
- ECG abnormalities.
- History of neurological conditions such as stroke, seizures, dementia or organic brain
syndrome.
- Mental retardation.
- Pregnant, verified by urine pregnancy test for females.
- Breast-feeding.
- Treated with benztropine currently or within the last four weeks.
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