SchizophreniaPhase 4NCT00383747
The Effects of Nicotine on Cognition in Schizophrenia
A Phase 4 study testing transdermal nicotine patch in people with Schizophrenia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Patients with schizophrenia have a variety cognitive deficits and nicotine has been shown to normalize some of these deficits. The purpose of this study is to investigate the effects of nicotine on cognition in schizophrenia.We will evaluate the effects of transdermal nicotine compared with placebo for attentional… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- transdermal nicotine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Jan 2009
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients:
- DSM IV diagnosis of schizophrenia,
- age 18 - 60 inclusive,
- able to provide informed consent,
- treated with antipsychotic medications at a stable dose for at least 4 weeks,
- not treated with an investigational medication in the past 30 days,
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- WRAT-3 IQ raw score greater than or equal to 35,
- non smokers for more than 3 months*,
- normal or corrected to normal vision.
- Non Smoking defined by:
- Self report of not smoking a single cigarette in the past 3 months.
- Salivary Cotinine level < 30 ng/ml at screening and on the day of testing
- Expired air CO < 9ppm on the day of the testing
- Control Group:
- Age 18 - 60 inclusive,
- able to provide informed consent,
- not treated with an investigational medication in the past 30 days,
- WRAT-3 IQ raw score greater than or equal to 35,
- non smokers for more than 3 months*,
- normal or corrected to normal vision,
- Non Smoking as defined above.
Who cannot join
- Patients:
- Use of any nicotine containing product in the past 3 months by self report,
- use of cholinesterase inhibitors such as galantamine in the past 3 months,
- untreated ischaemic heart disease,
- uncontrolled hypertension,
- current unstable serious medical illness (renal, neoplastic, hematological),
Show all 21Show fewer
- allergy to patches.
- Currently or planning to be pregnant in the next 8 weeks, as verified by positive pregnancy test, or childbearing potential and not using adequate contraception. Those not of childbearing potential include post-menopausal, surgically sterilized, and male participants.
- Substance abuse in the past month: self-reported, diagnosed during chart review, and verified by a positive salivary test for cotinine, cocaine, methamphetamine, amphetamine, ethanol, TCH, opiates or PCP at screen.
- Recent deterioration in mental state, current major depressive disorder, history of cognitive impairment secondary to other disorders such as head injury, dementia, general medical condition, diagnosis of mental retardation
- Controls:
- Past or present DSM IV diagnosis of schizophrenia, schizoaffective disorder, major depression, bipolar disorder, or mental retardation.
- First degree relative with diagnosis of schizophrenia or schizoaffective disorder,
- use of cholinesterase inhibitors such as galantamine in the past 3 months,
- untreated ischaemic heart disease,
- uncontrolled hypertension,
- current unstable serious medical illness (renal, neoplastic, hematological,)
- allergy to patches,
- currently or planning to be pregnant in the next 8 weeks, as verified by positive pregnancy test, or childbearing potential and not using adequate contraception. Those not of childbearing potential include post-menopausal, surgically sterilized, and male participants.
- Substance abuse in the past month: self-reported, diagnosed during chart review, and verified by a positive salivary test for cotinine, cocaine, methamphetamine, amphetamine, ethanol, TCH, opiates and PCP at screen.
- History of cognitive impairment secondary to other disorders such as head injury, dementia, general medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Schizophrenia Research Program
Boston, Massachusetts, 02114
About this study
Official title: A Double Blind Placebo Controlled Trial of the Effects of Transdermal Nicotine on Cognitive Function in Non-Smokers With and Without Schizophrenia
Patients with schizophrenia have a variety cognitive deficits and nicotine has been shown to normalize some of these deficits. The purpose of this study is to investigate the effects of nicotine on cognition in schizophrenia.We will evaluate the effects of transdermal nicotine compared with placebo for attentional impairments in non-smokers with schizophrenia and controls.
Read the detailed description
We propose to test the efficacy and safety of transdermal nicotine for attention and working memory in outpatients with stable symptoms of schizophrenia treated with high potency antipsychotic medications that do not smoke cigarettes or use nicotine-containing products. This is a randomized, double-blind, placebo-controlled pilot study to determine whether transdermal nicotine, initiated in a clinic setting and dosed for four hours is safe and effective for improving attention and spatial working memory deficits in patients with schizophrenia. This is an add-on study, subjects will continue with their usual medications and treatments throughout.
Subjects are 30- non-smoking outpatients with stable treated schizophrenia and 30 normal controls who do not have a major mental illness and who are matched for age sex and parental education. Subjects are randomized to one of 2 groups for order of receiving active and placebo patch, using a computer generated random number sequence. Randomization is concealed using opaque envelopes. Assessors and subjects are blind to group allocation.
The primary outcome measure is d' measure on the CPT-IP following a 4 hour administration of the transdermal nicotine patch. Secondary outcome measures are performance on tasks assessing attention, numeric and visuospatial working memory, psychomotor ability, executive functioning and motivation for reward following nicotine patch administration.
Specific Aims
- To evaluate the effectiveness of transdermal nicotine compared with placebo for attentional impairment in patients with schizophrenia Hypothesis 1.1: Subjects will demonstrate greater signal detection as measured by the d' (hits vs. false alarms) on the Continuous Performance Test Identical Pairs Version (CPT-IP) following 4-hour nicotine administration when compared with placebo administration. Hypothesis 1.2: Subjects will demonstrate decreased false alarms on the CPT-IP following 4-hour nicotine administration when compared with placebo administration. Hypothesis 1.3: Subjects will demonstrate decreased reaction time on the CPT-IP following 4- hour nicotine administration when compared with placebo administration.
- To evaluate the effect of transdermal nicotine in patients with schizophrenia compared with normal matched controls
Hypothesis 2.1: Schizophrenia subjects will demonstrate greater improvement in signal detection as measured by the d' (hits vs. false alarms) on the Continuous Performance test identical pairs version(CPT-IP) following 4-hour nicotine administration when compared with normal controls.
Hypothesis 2.2: Schizophrenia subjects will demonstrate greater reduction in false alarms on the CPT-IP following 4-hour nicotine administration when compared with normal controls.
Hypothesis 2.3: Schizophrenia subjects will demonstrate decreased reaction time on the CPT-IP following 4- hour nicotine administration when compared with normal controls. Performance Test Identical Pairs Version
- Conditions
- Schizophrenia
- Being tested
- transdermal nicotine patch
- Keywords
- cognition, nicotine, schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transdermal nicotine patchDrug
Also called Nicoderm CQ patch
14mg transdermal nicotine application
Transdermal Nicotine PatchDrug
14mg transdermal nicotine application
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Patch | Active comparator | Not described Receives: Drug: transdermal nicotine patch |
| Placebo Nicotine Patch | Placebo comparator | Not described Receives: Drug: Transdermal Nicotine Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Attention Measured by the Continuous Performance Test Identical Pairs Version
The primary outcome measure was attention as measured by the Continuous Performance Test Identical Pairs (CPT-IP) Version 4.0 (Biobehavioral Technologies, New York, USA), developed for use in patients with schizophrenia and normal controls. In this task, participants were asked to respond when two identical pairs of numbers were presented in sequence by pressing a mouse key as quickly as possible using the dominant hand.The stimuli were presented with increasing cognitive load in successive blocks: two-,three- and four-digit target in the first, second and third block, respectively. Hit reaction time, a standard outcome variables on the CPTIP, is presented here. It was measured 3 hrs after application of the patch
Measured: Visit 1 and visit 2 (separated by an interval of 7-10 days)
Secondary outcomes (3)
Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Visual Attention and Cognitive Interference as Measured by Three Card Stroop
This standard test of visual attention, processing speed and cognitive interference was performed, in which three cards (Stoelting Co., Wood Dale, IL, USA) were presented in order: the first card with color names, the second with colored patches of ink and the third with color namesprinted in incongruously colored ink. Participants were asked to read or name as many colors as possible in 45 s for each condition. The raw interference score was calculated by subtracting the predicted color-word score (calculated using raw word and color scores) from the observed raw color-word score. This value was converted to an interference T score by referring to a standardized table. A higher interference T score indicates better task performance with less interference. It was measured 3 hrs after application of the patch, after CPT
Measured: Visit 1 and visit 2 (separated by an interval of 7-10 days)
Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Letter Number Sequencing
This measure of working memory and auditory attention was performed under two conditions. In the first condition, participants were read progressively longer lists of letters and numbers and instructed to repeat these exactly as given, without reordering. In the second condition, participants were read progressively longer lists of numbers and letters and instructed to re-order the list and give the numbers first in ascending order and then the letters in alphabetical order (WMS-III). The sum of the trial scores provided the item score and the sum of the item scores provided the total score.It was measured 3 hrs after application of the patch, after CPT and Stroop. The total score ranges from 0 to 21.Higher scores of Letter number sequencing means better working memory and auditory attention
Measured: Visit 1 and visit 2 (separated by an interval of 7-10 days)
Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Lateralized Psychomotor Speed Measured by the Grooved Pegboard
The Grooved Pegboard (model 32025 Lafayette Instrument Company, Lafayette, IN, USA). In this test of lateralized psychomotor speed, participants had 45 s to place as many pegs as possible into grooves on a board using their dominant hand. The number of correctly placed pegs were recorded for each of the two trials.It was measured 3 hrs after application of the patch after CPT, Stroop and Letter number sequencing
Measured: Visit 1 and visit 2 (separated by an interval of 7-10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2006 (estimated)
- Study startApr 2004
- Primary completionJan 2009
- Study completionJan 2009
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute, North Suffolk Mental Health Association
- Responsible party
- Principal investigator, A. Eden Evins, Massachusetts General Hospital
- Investigators
- A E EVINS, MD MPH, Principal investigator, Massachusetts General Hosptal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383747
- Sponsor's protocol ID
- 04T574
- Other IDs
- CORRC 07-2004
- Status last verified
- Mar 2017
- First submitted
- 29 Sep 2006
- Last updated
- 28 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Barr RS, Culhane MA, Jubelt LE, Mufti RS, Dyer MA, Weiss AP, Deckersbach T, Kelly JF, Freudenreich O, Goff DC, Evins AE. The effects of transdermal nicotine on cognition in nonsmokers with schizophrenia and nonpsychiatric controls. Neuropsychopharmacology. 2008 Feb;33(3):480-90. doi: 10.1038/sj.npp.1301423. Epub 2007 Apr 18.
PubMed 17443126Barr RS, Pizzagalli DA, Culhane MA, Goff DC, Evins AE. A single dose of nicotine enhances reward responsiveness in nonsmokers: implications for development of dependence. Biol Psychiatry. 2008 Jun 1;63(11):1061-5. doi: 10.1016/j.biopsych.2007.09.015. Epub 2007 Nov 5.
PubMed 17976537Jubelt LE, Barr RS, Goff DC, Logvinenko T, Weiss AP, Evins AE. Effects of transdermal nicotine on episodic memory in non-smokers with and without schizophrenia. Psychopharmacology (Berl). 2008 Jul;199(1):89-98. doi: 10.1007/s00213-008-1133-8. Epub 2008 Jun 12.
PubMed 18548234
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Placebo Controlled Trial of the Effects of Transdermal Nicotine on Cognitive Function in Non-Smokers With and Without Schizophrenia
- ClinicalTrials.gov ID
- NCT00383747
- Acronym / sponsor ID
- 04T574
- Conditions
- Schizophrenia
- Keywords
- cognition, nicotine, schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute, North Suffolk Mental Health Association
- Study start
- Apr 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 3 Oct 2006 (estimated)
- Results
- Posted 28 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with schizophrenia have a variety cognitive deficits and nicotine has been shown to normalize some of these deficits. The purpose of this study is to investigate the effects of nicotine on cognition in schizophrenia.We will evaluate the effects of transdermal nicotine compared with placebo for attentional impairments in non-smokers with schizophrenia and controls.
Detailed description
We propose to test the efficacy and safety of transdermal nicotine for attention and working memory in outpatients with stable symptoms of schizophrenia treated with high potency antipsychotic medications that do not smoke cigarettes or use nicotine-containing products. This is a randomized, double-blind, placebo-controlled pilot study to determine whether transdermal nicotine, initiated in a clinic setting and dosed for four hours is safe and effective for improving attention and spatial working memory deficits in patients with schizophrenia. This is an add-on study, subjects will continue with their usual medications and treatments throughout.
Subjects are 30- non-smoking outpatients with stable treated schizophrenia and 30 normal controls who do not have a major mental illness and who are matched for age sex and parental education. Subjects are randomized to one of 2 groups for order of receiving active and placebo patch, using a computer generated random number sequence. Randomization is concealed using opaque envelopes. Assessors and subjects are blind to group allocation.
The primary outcome measure is d' measure on the CPT-IP following a 4 hour administration of the transdermal nicotine patch. Secondary outcome measures are performance on tasks assessing attention, numeric and visuospatial working memory, psychomotor ability, executive functioning and motivation for reward following nicotine patch administration.
Specific Aims
- To evaluate the effectiveness of transdermal nicotine compared with placebo for attentional impairment in patients with schizophrenia Hypothesis 1.1: Subjects will demonstrate greater signal detection as measured by the d' (hits vs. false alarms) on the Continuous Performance Test Identical Pairs Version (CPT-IP) following 4-hour nicotine administration when compared with placebo administration. Hypothesis 1.2: Subjects will demonstrate decreased false alarms on the CPT-IP following 4-hour nicotine administration when compared with placebo administration. Hypothesis 1.3: Subjects will demonstrate decreased reaction time on the CPT-IP following 4- hour nicotine administration when compared with placebo administration.
- To evaluate the effect of transdermal nicotine in patients with schizophrenia compared with normal matched controls
Hypothesis 2.1: Schizophrenia subjects will demonstrate greater improvement in signal detection as measured by the d' (hits vs. false alarms) on the Continuous Performance test identical pairs version(CPT-IP) following 4-hour nicotine administration when compared with normal controls.
Hypothesis 2.2: Schizophrenia subjects will demonstrate greater reduction in false alarms on the CPT-IP following 4-hour nicotine administration when compared with normal controls.
Hypothesis 2.3: Schizophrenia subjects will demonstrate decreased reaction time on the CPT-IP following 4- hour nicotine administration when compared with normal controls. Performance Test Identical Pairs Version
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine Patch | Active comparator | Drug: transdermal nicotine patch |
| Placebo Nicotine Patch | Placebo comparator | Drug: Transdermal Nicotine Patch |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- DSM IV diagnosis of schizophrenia,
- age 18 - 60 inclusive,
- able to provide informed consent,
- treated with antipsychotic medications at a stable dose for at least 4 weeks,
- not treated with an investigational medication in the past 30 days,
Key exclusion criteria (21 listed)
- Use of any nicotine containing product in the past 3 months by self report,
- use of cholinesterase inhibitors such as galantamine in the past 3 months,
- untreated ischaemic heart disease,
- uncontrolled hypertension,
- current unstable serious medical illness (renal, neoplastic, hematological),
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 |
|---|---|---|
| transdermal nicotine patchAlso: Nicoderm CQ patch14mg transdermal nicotine application | Drug | Nicotine Patch |
| Transdermal Nicotine Patch14mg transdermal nicotine application | Drug | Placebo Nicotine Patch |
Primary outcome
Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Attention Measured by the Continuous Performance Test Identical Pairs Version
Time frame: Visit 1 and visit 2 (separated by an interval of 7-10 days)
The primary outcome measure was attention as measured by the Continuous Performance Test Identical Pairs (CPT-IP) Version 4.0 (Biobehavioral Technologies, New York, USA), developed for use in patients with schizophrenia and normal controls. In this task, participants were asked to respond when two identical pairs of numbers were presented in sequence by pressing a mouse key as quickly as possible using the dominant hand.The stimuli were presented with increasing cognitive load in successive blocks: two-,three- and four-digit target in the first, second and third block, respectively. Hit reaction time, a standard outcome variables on the CPTIP, is presented here. It was measured 3 hrs after application of the patch
3 secondary outcomes
Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Visual Attention and Cognitive Interference as Measured by Three Card Stroop
Time frame: Visit 1 and visit 2 (separated by an interval of 7-10 days)
Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Letter Number Sequencing
Time frame: Visit 1 and visit 2 (separated by an interval of 7-10 days)
Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Lateralized Psychomotor Speed Measured by the Grooved Pegboard
Time frame: Visit 1 and visit 2 (separated by an interval of 7-10 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17443126Barr RS, Culhane MA, Jubelt LE, Mufti RS, Dyer MA, Weiss AP, Deckersbach T, Kelly JF, Freudenreich O, Goff DC, Evins AE. The effects of transdermal nicotine on cognition in nonsmokers with schizophrenia and nonpsychiatric controls. Neuropsychopharmacology. 2008 Feb;33(3):480-90. doi: 10.1038/sj.npp.1301423. Epub 2007 Apr 18.
- Results publication: PubMed 17976537Barr RS, Pizzagalli DA, Culhane MA, Goff DC, Evins AE. A single dose of nicotine enhances reward responsiveness in nonsmokers: implications for development of dependence. Biol Psychiatry. 2008 Jun 1;63(11):1061-5. doi: 10.1016/j.biopsych.2007.09.015. Epub 2007 Nov 5.
- Results publication: PubMed 18548234Jubelt LE, Barr RS, Goff DC, Logvinenko T, Weiss AP, Evins AE. Effects of transdermal nicotine on episodic memory in non-smokers with and without schizophrenia. Psychopharmacology (Berl). 2008 Jul;199(1):89-98. doi: 10.1007/s00213-008-1133-8. Epub 2008 Jun 12.
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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.
A E EVINS, MD MPH principal investigator
Massachusetts General Hosptal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing transdermal nicotine patch in people with Schizophrenia, run by Massachusetts General Hospital 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 21 inclusion and 21 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 28 Apr 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2017). 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?
Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Attention Measured by the Continuous Performance Test Identical Pairs Version (time frame: Visit 1 and visit 2 (separated by an interval of 7-10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00383747, which also lists 3 linked publications.
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 28 Apr 2017.