Nicotine DependenceNCT01034085
Effects of Nicotine on Areas of Impaired and Preserved Functioning in Schizophrenia
An observational study of Nicotine Dependence and Schizophrenia, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: Some people with schizophrenia have problems with their working memory and paying attention for extended periods. These difficulties cannot be treated with antipsychotic medications or with many standard therapies. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Schizophrenia
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2009to 11 Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants:
- Age 18 through 55. The aim is to minimize population inhomogeneity related to cognitive decline due to normal aging.
- Smoker of 5 or more cigarettes, cigarillos or cigars per day, on 5 or more days/week, for at least the last 12 months
- Normal or corrected to normal visual acuity (at least 20/100).
- Participants with mental illness, additional inclusion criteria:
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- Ability to give written informed consent
- Four weeks of stable pharmacological treatment (same psychiatric medication at same dose)
Who cannot join
- All participants:
- History of myocardial infarction, heart failure, angina, stroke or severe arrhythmias, EKG abnormalities as specified under Screening methods
- Uncontrolled high blood pressure (resting systolic above 150 or diastolic above 90 mm Hg)
- Neurological conditions such as stroke, seizures, dementia or organic brain syndrome
- Any condition likely to impair cognitive function such as mental retardation, attention deficit disorder or severe pharmacological sedation
- Treatment for tobacco dependence in the last four months
Show all 13Show fewer
- Alcohol or substance abuse or dependence other than nicotine within the last 12 months
- Pregnancy, verified by urine pregnancy test for females at first visit and in the beginning of each of the two patch administration sessions
- Lactating
- Healthy controls, additional exclusion criterion:
- Current psychiatric Axis I disorder or Axis II schizophrenia spectrum disorder, verified by Structured Clinical Interview for DSM-IV (SCID)
- Participants with mental illness, additional exclusion criterion:
- Treated with benztropine (a nicotinic and muscarinic antagonist) or with an acetylcholine esterase inhibitor currently or within the last four weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center (MPRC) 55 Wade Avenue
Catonsville, Maryland, 21228
About this study
Background:
- Some people with schizophrenia have problems with their working memory and paying attention for extended periods. These difficulties cannot be treated with antipsychotic medications or with many standard therapies.
- The prevalence of cigarette smoking among individuals with schizophrenia is about three times higher than in the general population. Research has shown that nicotine, the addictive component found in cigarettes, can help improve attentional and working memory performance. Researchers are interested in learning more about whether there may be an overlap in the cognitive functions beneficially affected by nicotine and areas of dysfunction in individuals with schizophrenia.
Read more
Objectives:
- To evaluate the potential of transdermal nicotine to alleviate cognitive deficits in schizophrenia, and to determine whether naturally maintained cigarette-smoking, in comparison, is an effective self-medication.
- To gather preliminary data on genetics that may account for individual and group differences in the performance effects of nicotine.
Eligibility:
- Current smokers (25 or more cigarettes per week for at least 1 year) between 18 and 55 years of age who are either healthy volunteers or have been diagnosed with schizophrenia/schizoaffective disorder.
Design:
- The study will require five visits to the research center, with an initial screening visit, a training session, and three test sessions. Ideally, all visits will occur 1 week apart.
- Training session: Participants will receive training on the types of computerized cognitive and attentional behavior tests that will be given during the active portion of the study. Participants will also fill out questionnaires on nicotine use and other alcohol and drug use.
- Test sessions: Participants will be assigned to random groups and will complete tests that assess cognitive performance (a) while maintaining their usual smoking behavior, (b) after minimal deprivation (3.5 hours without smoking) while wearing a placebo patch, and (c) under the influence of a standard nicotine patch. The order of these sessions will be different for individual participants.
- Participants will provide blood samples throughout the research study for evaluation purposes.
Read the detailed description
Objective:
- To evaluate the potential of transdermal nicotine to alleviate distinct cognitive deficits in schizophrenia, and to determine whether naturally maintained cigarette-smoking, in comparison, is an effective self-medication.
- To gather preliminary data on genotypes that may account for interindividual and group differences in the performance effects of nicotine.
Study population:
45 regular smokers with schizophrenia, 45 matched control smokers (greater than or equal to 5 cigarettes/day).
Design:
Double-blind, placebo-controlled, within-subject study, evaluating cognitive functions under conditions of normal smoking, transdermal nicotine (14 mg/day), and placebo (minimal tobacco deprivation).
Outcome measures:
Measures of cognitive task performance, measures of subjective state, plasma concentrations of nicotine and metabolites, and genotype with regards to genes coding for nicotinic receptor subunits, MAO, and COMT.
- Conditions
- Nicotine Dependence, Schizophrenia
- Keywords
- Nicotine, Schizophrenia, Cognition, Genes, Smoking, Cigarette Smoking
- Medical subject headings
- Tobacco Use Disorder, Schizophrenia, Smoking, Cigarette Smoking
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive task performance
Secondary outcomes (1)
Measures of subjective state plasma concentrations of nicotine and metabolites genoytype with regards to genes that may affect nicotine response.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study start2 Jun 2009
- Study completion11 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Other
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Elliot Stein, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034085
- Sponsor's protocol ID
- 999909445
- Other IDs
- 09-DA-N445
- Status last verified
- 11 Jun 2013
- First submitted
- 16 Dec 2009
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Adams CE, Stevens KE. Evidence for a role of nicotinic acetylcholine receptors in schizophrenia. Front Biosci. 2007 May 1;12:4755-72. doi: 10.2741/2424.
PubMed 17485411Apud JA, Weinberger DR. Treatment of cognitive deficits associated with schizophrenia: potential role of catechol-O-methyltransferase inhibitors. CNS Drugs. 2007;21(7):535-57. doi: 10.2165/00023210-200721070-00002.
PubMed 17579498Arinami T, Ishiguro H, Onaivi ES. Polymorphisms in genes involved in neurotransmission in relation to smoking. Eur J Pharmacol. 2000 Dec 27;410(2-3):215-226. doi: 10.1016/s0014-2999(00)00816-5.
PubMed 11134671
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nicotine on Areas of Impaired and Preserved Functioning in Schizophrenia
- ClinicalTrials.gov ID
- NCT01034085
- Acronym / sponsor ID
- 999909445
- Conditions
- Nicotine Dependence, Schizophrenia
- Keywords
- Nicotine, Schizophrenia, Cognition, Genes, Smoking, Cigarette Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 2 Jun 2009
- Study completion
- 11 Jun 2013
- First posted
- 17 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Some people with schizophrenia have problems with their working memory and paying attention for extended periods. These difficulties cannot be treated with antipsychotic medications or with many standard therapies.
- The prevalence of cigarette smoking among individuals with schizophrenia is about three times higher than in the general population. Research has shown that nicotine, the addictive component found in cigarettes, can help improve attentional and working memory performance. Researchers are interested in learning more about whether there may be an overlap in the cognitive functions beneficially affected by nicotine and areas of dysfunction in individuals with schizophrenia.
Objectives:
- To evaluate the potential of transdermal nicotine to alleviate cognitive deficits in schizophrenia, and to determine whether naturally maintained cigarette-smoking, in comparison, is an effective self-medication.
- To gather preliminary data on genetics that may account for individual and group differences in the performance effects of nicotine.
Eligibility:
- Current smokers (25 or more cigarettes per week for at least 1 year) between 18 and 55 years of age who are either healthy volunteers or have been diagnosed with schizophrenia/schizoaffective disorder.
Design:
- The study will require five visits to the research center, with an initial screening visit, a training session, and three test sessions. Ideally, all visits will occur 1 week apart.
- Training session: Participants will receive training on the types of computerized cognitive and attentional behavior tests that will be given during the active portion of the study. Participants will also fill out questionnaires on nicotine use and other alcohol and drug use.
- Test sessions: Participants will be assigned to random groups and will complete tests that assess cognitive performance (a) while maintaining their usual smoking behavior, (b) after minimal deprivation (3.5 hours without smoking) while wearing a placebo patch, and (c) under the influence of a standard nicotine patch. The order of these sessions will be different for individual participants.
- Participants will provide blood samples throughout the research study for evaluation purposes.
Detailed description
Objective:
- To evaluate the potential of transdermal nicotine to alleviate distinct cognitive deficits in schizophrenia, and to determine whether naturally maintained cigarette-smoking, in comparison, is an effective self-medication.
- To gather preliminary data on genotypes that may account for interindividual and group differences in the performance effects of nicotine.
Study population:
45 regular smokers with schizophrenia, 45 matched control smokers (greater than or equal to 5 cigarettes/day).
Design:
Double-blind, placebo-controlled, within-subject study, evaluating cognitive functions under conditions of normal smoking, transdermal nicotine (14 mg/day), and placebo (minimal tobacco deprivation).
Outcome measures:
Measures of cognitive task performance, measures of subjective state, plasma concentrations of nicotine and metabolites, and genotype with regards to genes coding for nicotinic receptor subunits, MAO, and COMT.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18 through 55. The aim is to minimize population inhomogeneity related to cognitive decline due to normal aging.
- Smoker of 5 or more cigarettes, cigarillos or cigars per day, on 5 or more days/week, for at least the last 12 months
- Normal or corrected to normal visual acuity (at least 20/100).
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- Ability to give written informed consent
Key exclusion criteria (13 listed)
- History of myocardial infarction, heart failure, angina, stroke or severe arrhythmias, EKG abnormalities as specified under Screening methods
- Uncontrolled high blood pressure (resting systolic above 150 or diastolic above 90 mm Hg)
- Neurological conditions such as stroke, seizures, dementia or organic brain syndrome
- Any condition likely to impair cognitive function such as mental retardation, attention deficit disorder or severe pharmacological sedation
- Treatment for tobacco dependence in the last four months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive task performance
1 secondary outcome
Measures of subjective state plasma concentrations of nicotine and metabolites genoytype with regards to genes that may affect nicotine response.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 17485411Adams CE, Stevens KE. Evidence for a role of nicotinic acetylcholine receptors in schizophrenia. Front Biosci. 2007 May 1;12:4755-72. doi: 10.2741/2424.
- Background: PubMed 17579498Apud JA, Weinberger DR. Treatment of cognitive deficits associated with schizophrenia: potential role of catechol-O-methyltransferase inhibitors. CNS Drugs. 2007;21(7):535-57. doi: 10.2165/00023210-200721070-00002.
- Background: PubMed 11134671Arinami T, Ishiguro H, Onaivi ES. Polymorphisms in genes involved in neurotransmission in relation to smoking. Eur J Pharmacol. 2000 Dec 27;410(2-3):215-226. doi: 10.1016/s0014-2999(00)00816-5.
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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.
Elliot Stein, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nicotine Dependence and Schizophrenia, run by National Institute on Drug Abuse (NIDA) 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 8 inclusion and 13 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 5 Apr 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive task performance. 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 NCT01034085, 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 5 Apr 2018.