SchizophreniaNCT02069392
Nicotinic Enhancement of Cognitive Remediation Training in Schizophrenia
A study testing Cognitive remediation training and Nicotine polacrilex lozenge in people with Schizophrenia and Schizoaffective Disorder, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Cognitive remediation training and Nicotine polacrilex lozenge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Pregnant, verified by urine pregnancy test for females.
- Breast-feeding.
- Treated with benztropine currently or within the last four weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center
Baltimore, Maryland, 21228
About this study
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.
Read more
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
- Being tested
- Cognitive remediation training, Nicotine polacrilex lozenge
- Keywords
- schizophrenia, cognition, cognitive remediation, nicotine
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive remediation trainingBehavioural
Also called Posit Science cognitive remediation training
Nicotine polacrilex lozengeDrug
Also called Nicorette polacrilex lozenges, GlaxoSmithKline, 2 mg and 4 mg
Of interest are the effects of nicotine on cognitive remediation training benefits.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cognitive remediation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Clinician-administered interview about daily life cognitive functioning. The CAI assesses 10 items related to working memory, attention/vigilance, learning/memory, problem solving, processing speed, and social cognition. The total score ranges from 1 (inability to maintain personal hygiene due to cognitive deficits) to 100 (superior cognitive functioning in a wide range of activities). A score of 55 corresponds to moderate cognitive symptoms, e.g. persistent problems paying attention or forgetting scheduled events.
Measured: baseline (week 0) and post-intervention (week 10)
Change in Abbreviated Schizophrenia Quality of Life Scale Score
Semi-structured clinician interview measuring functional outcome and quality of life in people with schizophrenia. Includes subjective questions regarding life satisfaction and objective indicators of social and occupational role functioning during preceding 4 weeks. Seven items are scored on a 0 (severe impairment) to 6 (high functioning) scale. The total score ranges from 0 to 42, with larger values reflecting higher functioning.
Measured: baseline (week 0) and post-intervention (week 10)
UCSD Performance-Based Skills Assessment (UPSA) Score
Measures ability to perform real-life tasks by standardized role-play. Scores reflect percent correct, i.e. range from 0-100 with higher scores representing better performance.
Measured: baseline (week 0) and post-intervention (week 10)
Calgary Depression Scale Score
Clinician scale developed to assess the level of depression in schizophrenia. 9 items assess symptoms of depression and overall rater impression on a scale from 0 (absent) to 3 (severe).
Measured: baseline (week 0), post-intervention (week 10)
Scale for the Assessment of Negative Symptoms (SANS) Score
Clinician rating scale of negative symptoms in schizophrenia. Within each of 5 domains, separate symptoms are rated from 0 (absent) to 5 (severe). Total scores are the sum of 22 subscales and range from 0 to 110, with larger values reflecting higher negative symptoms.
Measured: baseline (week 0), post-intervention (week 10)
Brief Psychiatric Rating Scale (BPRS) Score
Clinician rating scale to measure psychotic symptoms. Each of 20 items is scored 1-7. Total scores are the sum of all items and range from 20 to 140, with larger values reflecting worse symptoms.
Measured: baseline (week 0), post-intervention (week 10)
Training Exercise Parameters: Visual and Sound Sweeps
Some of the Posit Science exercises provide an assessment tool of training progress on task parameters, which adjust continuously to keep performance at ~85% correct. Enhanced sensory processing speed and precision is considered the central building block of training benefits. Therefore, we analyzed the two exercises aimed at training these processes. Performance is quantified as stimulus presentation time in ms of visual or sound "sweeps", which the participant has to judge in terms of change across space or time. Smaller values reflect better performance. Visual and sound sweeps were averaged.
Measured: baseline (week 0), post-intervention (week 10), 4-week follow-up
Change in Working Memory Capacity
Derived from a computerized change localization task. One to four colored squares are shown for 100 ms. After a delay, they reappear and the task is to click on the one square that has changed color (50% chance). Performance is expressed as the percentage of correct responses.
Measured: baseline (week 1) and post-intervention (week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Britta Hahn, University of Maryland, Baltimore
- Investigators
- Britta Hahn, Ph.D., Principal investigator, University of Maryland School of Medicine, Maryland Psychiatric Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069392
- Sponsor's protocol ID
- HP-00058233
- Other IDs
- R21MH095824
- Status last verified
- Sep 2019
- First submitted
- 5 Feb 2014
- Last updated
- 12 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotinic Enhancement of Cognitive Remediation Training in Schizophrenia
- ClinicalTrials.gov ID
- NCT02069392
- Acronym / sponsor ID
- HP-00058233
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- schizophrenia, cognition, cognitive remediation, nicotine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Posted 8 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive remediation training with nicotine | Active comparator | Behavioral: Cognitive remediation training, Drug: Nicotine polacrilex lozengeParticipants 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. |
| Cognitive remediation training without nicotine | Placebo comparator | Behavioral: Cognitive remediation trainingParticipants will complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants will consume a placebo lozenge prior to the training. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive remediation trainingAlso: Posit Science cognitive remediation training | Behavioural | Cognitive remediation training with nicotine, Cognitive remediation training without nicotine |
| Nicotine polacrilex lozengeAlso: Nicorette polacrilex lozenges, GlaxoSmithKline, 2 mg and 4 mgOf interest are the effects of nicotine on cognitive remediation training benefits. | Drug | Cognitive remediation training with nicotine |
Primary outcome
MATRICS Consensus Cognitive Battery (MCCB) Composite Score
Time frame: baseline (week 0), weeks 4 and 7 of intervention, end-of-intervention (week 10), 4-week follow-up
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.
8 secondary outcomes
Cognitive Assessment Interview (CAI) Score
Time frame: baseline (week 0) and post-intervention (week 10)
Change in Abbreviated Schizophrenia Quality of Life Scale Score
Time frame: baseline (week 0) and post-intervention (week 10)
UCSD Performance-Based Skills Assessment (UPSA) Score
Time frame: baseline (week 0) and post-intervention (week 10)
Calgary Depression Scale Score
Time frame: baseline (week 0), post-intervention (week 10)
Scale for the Assessment of Negative Symptoms (SANS) Score
Time frame: baseline (week 0), post-intervention (week 10)
Brief Psychiatric Rating Scale (BPRS) Score
Time frame: baseline (week 0), post-intervention (week 10)
Training Exercise Parameters: Visual and Sound Sweeps
Time frame: baseline (week 0), post-intervention (week 10), 4-week follow-up
Change in Working Memory Capacity
Time frame: baseline (week 1) and post-intervention (week 10)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britta Hahn, Ph.D. principal investigator
University of Maryland School of Medicine, Maryland Psychiatric Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive remediation training and Nicotine polacrilex lozenge in people with Schizophrenia and Schizoaffective Disorder, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MATRICS Consensus Cognitive Battery (MCCB) Composite Score (time frame: baseline (week 0), weeks 4 and 7 of intervention, end-of-intervention (week 10), 4-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.