Nicotinic Enhancement of Cognitive Remediation Training in Schizophrenia

NCT02069392 | Completed Results DMC

• 2 other identifiers: HP-00058233R21MH095824
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

schizophrenia; cognition; cognitive remediation; nicotine

Outcome Measures

Primary Outcomes (1)

• MATRICS Consensus Cognitive Battery (MCCB) Composite Score

  The MCCB is an FDA-approved assessment tool for trials of cognition-enhancing treatments in people with schizophrenia. The MCCB is comprised of the following domains: 1) Speed of Processing; 2) Attention/Vigilance; 3) Working Memory; 4) Verbal Learning; 5) Visual Learning; 6) Reasoning and Problem Solving; and 7) Social Cognition. The composite score is standardized to a T-scale (mean=50, standard deviation=10) based on healthy control normative data. Better performance is reflected by higher scores.

  baseline (week 0), weeks 4 and 7 of intervention, end-of-intervention (week 10), 4-week follow-up

Secondary Outcomes (8)

• Cognitive Assessment Interview (CAI) Score

  baseline (week 0) and post-intervention (week 10)

• Change in Abbreviated Schizophrenia Quality of Life Scale Score

  baseline (week 0) and post-intervention (week 10)

• UCSD Performance-Based Skills Assessment (UPSA) Score

  baseline (week 0) and post-intervention (week 10)

• Calgary Depression Scale Score

  baseline (week 0), post-intervention (week 10)

• Scale for the Assessment of Negative Symptoms (SANS) Score

  baseline (week 0), post-intervention (week 10)

Study Arms (2)

Cognitive remediation training with nicotine

ACTIVE COMPARATOR

Participants will complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants will consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.

Behavioral: Cognitive remediation training; Drug: Nicotine polacrilex lozenge

Cognitive remediation training without nicotine

PLACEBO COMPARATOR

Participants will complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants will consume a placebo lozenge prior to the training.

Behavioral: Cognitive remediation training

Interventions

Cognitive remediation training BEHAVIORAL

Also known as: Posit Science cognitive remediation training

Cognitive remediation training with nicotine; Cognitive remediation training without nicotine

Nicotine polacrilex lozenge DRUG

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

Also known as: Nicorette polacrilex lozenges, GlaxoSmithKline, 2 mg and 4 mg

Cognitive remediation training with nicotine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Maryland Psychiatric Research Center

Baltimore, Maryland, 21228, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

halofantrine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Britta Hahn, Ph.D.
• Organization: University of Maryland School of Medicine

bhahn@som.umaryland.edu

4104026112

Study Officials

• Britta Hahn, Ph.D.

  University of Maryland School of Medicine, Maryland Psychiatric Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Britta Hahn, Ph.D.)

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 24, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 12, 2019
• Results First Posted: April 8, 2019

Record last verified: 2019-09

Locations

US (1)