SchizophreniaNCT01037075
Influence of Nicotine on Cognitive Function in Schizophrenic Patients With and Without Comorbid Drug Dependence
An observational study of Schizophrenia and Drug Abuse/Dependency, run by National Institute on Drug Abuse (NIDA) at 2 sites in United States.
Trial summary
Background: Individuals with schizophrenia have a significantly higher tendency to develop substance abuse or dependence than the general population. For instance, people with schizophrenia smoke much more than the general population, and many are dependent on street drugs such as cocaine and heroin. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Drug Abuse/Dependency
- How many people
- 82 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 May 2006to 22 Jan 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants must meet the following criteria:
- age 18 60
- smoke 10 or more cigarettes/day for at least the past year
- Experimental groups 1 and 2, additional criteria:
- -DSM-IV diagnosis of schizophrenia or schizoaffective disorder (assessments pertaining to these diagnoses will be done in other MPRC screening protocols).
- Experimental group 2, additional criteria:
- -DSM-IV diagnosis of abuse or dependence on cocaine and/or heroin or on methadone or buprenorphine maintenance.
Who cannot join
- Comprehensive medical history:
- -Exclusions: Heart disease, uncontrolled blood pressure (persistent systolic above 155 or diastolic above 95), neurological conditions (stroke, seizure, history of head injury), asthma, emphysema, chronic bronchitis, chronic obstructive pulmonary disease, pathology of nasal passages that precludes the effective administration of nicotine nasal spray.
- Drug Use Survey
- All subjects:
- Exclude if treatment for tobacco dependence during the previous 6 months.
- Healthy controls and schizophrenic patients without comorbid drug abuse or dependence: Exclude if history alcohol or other substance dependence ever, or alcohol or other substance abuse in the past year. Verify abstinence from controlled substances with urine screen (Iscreen). Participants in the above 2 groups who are positive for any illicit drug (with the exception of marijuana) will be excluded.
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- Structured Clinical Interview for DSM-IV
- -Healthy controls: exclude if any current psychiatric disorder
- Urine pregnancy for females:
- -Exclude if positive.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, 21224
Matthews Media Group
Rockville, Maryland, 20850
About this study
Background:
- Individuals with schizophrenia have a significantly higher tendency to develop substance abuse or dependence than the general population. For instance, people with schizophrenia smoke much more than the general population, and many are dependent on street drugs such as cocaine and heroin. However, these individuals are rarely included in research studies that might provide more information about treatments for both schizophrenia and substance abuse.
- Strong evidence suggests that schizophrenia and substance dependence have similar effects on the brain, affecting attention, memory, and eye movement. Other research indicates that schizophrenia and substance dependence affect the same parts of the dopamine system, contributing to problems in brain function that require treatment. These new developments provide a strong rationale to study the combination of schizophrenia and substance dependence.
- Nicotine may help improve brain function and thinking in individuals with both schizophrenia and drug dependence. Some of the thinking and memory problems experienced by these individuals can be treated with nicotine. However, more research is needed to determine exactly how nicotine affects individuals with both schizophrenia and drug dependence.
Read more
Objectives:
- To determine whether individuals with schizophrenia and drug dependence show impairment in tests of eye tracking, attention, and memory compared with healthy control subjects.
- To evaluate the effect of nicotine on eye tracking, attention, and memory in individuals with both schizophrenia and substance dependence.
Eligibility:
- Current smokers (at least 10 cigarettes per day for the past year) between 18 and 55 years of age who (1) have been diagnosed with schizophrenia/schizoaffective disorder, (2) have been diagnosed with schizophrenia/schizoaffective disorder and are currently using heroin and/or cocaine, or (3) are healthy individuals with no family history of psychotic illness.
Design:
- The study will consist of one training session and three testing sessions. Each session will last about 2 hours.
- The training session will introduce participants to the study tests and evaluate their tolerance of the nicotine nasal spray used in the study. Participants who cannot tolerate the higher dose of the spray will not continue in the study.
- At the start of each testing session, smokers will have one cigarette to standardize the time of the most recent exposure to nicotine.
- During the testing sessions, participants will receive a placebo spray, a lower dose of nicotine, or a higher dose of nicotine, and then will be asked to perform tests that evaluate attention, memory, and other thinking tasks.
Read the detailed description
Objective:
Specific aim 1: To test the hypothesis that individuals with comorbid schizophrenia and drug dependence will show impaired neurocognitive functions in anticipatory learning of eyetracking, attention, and memory performance compared to healthy controls subjects.
Specific aim 2: To test the hypothesis that nicotine will dose-dependently improve anticipatory learning of eyetracking, attention, and memory performance in individuals with comorbid schizophrenia and substance dependence.
Study Population:
Male and nonpregnant-female smokers 18 to 55 years of age, from the following subject groups: (1) patients with a DSM IV diagnosis of schizophrenia (2) patients with dual DSM IV diagnoses of schizophrenia and heroin and/or cocaine dependence or abuse, or on methadone or beprenorphine maintenance and (3) healthy individuals with no family history of psychotic illness.
Design:
This study will be a double-blind, placebo controlled trial of nicotine or placebo nasal sprays. Participants will have four visits. After the training session, participants will be administered one dose (0, 1 or 2 mg) of nicotine nasal spray during each of the 3 experimental sessions. The dose will be given 5 minutes prior to the cognitive task batteries.
Outcome Measures:
Vital signs, moods, and performance on tasks assessing eye movement (initiation latency, initiation acceleration, closed-loop pursuit gain), attention (Continuous Performance and Digit Symbol Substitution Tasks), and memory (delayed recognition and nback).
- Conditions
- Schizophrenia, Drug Abuse/Dependency
- Keywords
- Schizophrenia, Dual Diagnosis, Nicotine Nasal Spray, Drug Abuse/Dependence, Cognitive Processes
- Medical subject headings
- Schizophrenia, Substance-Related Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study start14 May 2006
- Study completion22 Jan 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 SchizophreniaStudies 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
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Maryland, College Park
- Investigators
- Carol Myers, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037075
- Sponsor's protocol ID
- 999906400
- Other IDs
- 06-DA-N400
- Status last verified
- 22 Jan 2013
- First submitted
- 18 Dec 2009
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Avila MT, Sherr JD, Hong E, Myers CS, Thaker GK. Effects of nicotine on leading saccades during smooth pursuit eye movements in smokers and nonsmokers with schizophrenia. Neuropsychopharmacology. 2003 Dec;28(12):2184-91. doi: 10.1038/sj.npp.1300265.
PubMed 12968127Bennett ME, Bellack AS, Gearon JS. Treating substance abuse in schizophrenia. An initial report. J Subst Abuse Treat. 2001 Mar;20(2):163-75. doi: 10.1016/s0740-5472(00)00167-7.
PubMed 11306219Berman SM, Martinez RA, Noble EP. Familial alcoholism and ERPs: differences in probability sensitivity? Alcohol Alcohol. 1993 Nov;28(6):695-707.
PubMed 8147978
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Nicotine on Cognitive Function in Schizophrenic Patients With and Without Comorbid Drug Dependence
- ClinicalTrials.gov ID
- NCT01037075
- Acronym / sponsor ID
- 999906400
- Conditions
- Schizophrenia, Drug Abuse/Dependency
- Keywords
- Schizophrenia, Dual Diagnosis, Nicotine Nasal Spray, Drug Abuse/Dependence, Cognitive Processes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- University of Maryland, College Park
- Study start
- 14 May 2006
- Study completion
- 22 Jan 2013
- First posted
- 21 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:
- Individuals with schizophrenia have a significantly higher tendency to develop substance abuse or dependence than the general population. For instance, people with schizophrenia smoke much more than the general population, and many are dependent on street drugs such as cocaine and heroin. However, these individuals are rarely included in research studies that might provide more information about treatments for both schizophrenia and substance abuse.
- Strong evidence suggests that schizophrenia and substance dependence have similar effects on the brain, affecting attention, memory, and eye movement. Other research indicates that schizophrenia and substance dependence affect the same parts of the dopamine system, contributing to problems in brain function that require treatment. These new developments provide a strong rationale to study the combination of schizophrenia and substance dependence.
- Nicotine may help improve brain function and thinking in individuals with both schizophrenia and drug dependence. Some of the thinking and memory problems experienced by these individuals can be treated with nicotine. However, more research is needed to determine exactly how nicotine affects individuals with both schizophrenia and drug dependence.
Objectives:
- To determine whether individuals with schizophrenia and drug dependence show impairment in tests of eye tracking, attention, and memory compared with healthy control subjects.
- To evaluate the effect of nicotine on eye tracking, attention, and memory in individuals with both schizophrenia and substance dependence.
Eligibility:
- Current smokers (at least 10 cigarettes per day for the past year) between 18 and 55 years of age who (1) have been diagnosed with schizophrenia/schizoaffective disorder, (2) have been diagnosed with schizophrenia/schizoaffective disorder and are currently using heroin and/or cocaine, or (3) are healthy individuals with no family history of psychotic illness.
Design:
- The study will consist of one training session and three testing sessions. Each session will last about 2 hours.
- The training session will introduce participants to the study tests and evaluate their tolerance of the nicotine nasal spray used in the study. Participants who cannot tolerate the higher dose of the spray will not continue in the study.
- At the start of each testing session, smokers will have one cigarette to standardize the time of the most recent exposure to nicotine.
- During the testing sessions, participants will receive a placebo spray, a lower dose of nicotine, or a higher dose of nicotine, and then will be asked to perform tests that evaluate attention, memory, and other thinking tasks.
Detailed description
Objective:
Specific aim 1: To test the hypothesis that individuals with comorbid schizophrenia and drug dependence will show impaired neurocognitive functions in anticipatory learning of eyetracking, attention, and memory performance compared to healthy controls subjects.
Specific aim 2: To test the hypothesis that nicotine will dose-dependently improve anticipatory learning of eyetracking, attention, and memory performance in individuals with comorbid schizophrenia and substance dependence.
Study Population:
Male and nonpregnant-female smokers 18 to 55 years of age, from the following subject groups: (1) patients with a DSM IV diagnosis of schizophrenia (2) patients with dual DSM IV diagnoses of schizophrenia and heroin and/or cocaine dependence or abuse, or on methadone or beprenorphine maintenance and (3) healthy individuals with no family history of psychotic illness.
Design:
This study will be a double-blind, placebo controlled trial of nicotine or placebo nasal sprays. Participants will have four visits. After the training session, participants will be administered one dose (0, 1 or 2 mg) of nicotine nasal spray during each of the 3 experimental sessions. The dose will be given 5 minutes prior to the cognitive task batteries.
Outcome Measures:
Vital signs, moods, and performance on tasks assessing eye movement (initiation latency, initiation acceleration, closed-loop pursuit gain), attention (Continuous Performance and Digit Symbol Substitution Tasks), and memory (delayed recognition and nback).
Study design
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age 18 60
- smoke 10 or more cigarettes/day for at least the past year
- -DSM-IV diagnosis of schizophrenia or schizoaffective disorder (assessments pertaining to these diagnoses will be done in other MPRC screening protocols).
- -DSM-IV diagnosis of abuse or dependence on cocaine and/or heroin or on methadone or buprenorphine maintenance.
Key exclusion criteria (10 listed)
- -Exclusions: Heart disease, uncontrolled blood pressure (persistent systolic above 155 or diastolic above 95), neurological conditions (stroke, seizure, history of head injury), asthma, emphysema, chronic bronchitis, chronic obstructive pulmonary disease, pathology of nasal passages that precludes the effective administration of nicotine nasal spray.
- Drug Use Survey
- Exclude if treatment for tobacco dependence during the previous 6 months.
- Healthy controls and schizophrenic patients without comorbid drug abuse or dependence: Exclude if history alcohol or other substance dependence ever, or alcohol or other substance abuse in the past year. Verify abstinence from controlled substances with urine screen (Iscreen). Participants in the above 2 groups who are positive for any illicit drug (with the exception of marijuana) will be excluded.
- Structured Clinical Interview for DSM-IV
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
Not reported in the source record.
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 16 Dec 2019.
- Background: PubMed 12968127Avila MT, Sherr JD, Hong E, Myers CS, Thaker GK. Effects of nicotine on leading saccades during smooth pursuit eye movements in smokers and nonsmokers with schizophrenia. Neuropsychopharmacology. 2003 Dec;28(12):2184-91. doi: 10.1038/sj.npp.1300265.
- Background: PubMed 11306219Bennett ME, Bellack AS, Gearon JS. Treating substance abuse in schizophrenia. An initial report. J Subst Abuse Treat. 2001 Mar;20(2):163-75. doi: 10.1016/s0740-5472(00)00167-7.
- Background: PubMed 8147978Berman SM, Martinez RA, Noble EP. Familial alcoholism and ERPs: differences in probability sensitivity? Alcohol Alcohol. 1993 Nov;28(6):695-707.
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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.
Carol Myers, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Drug Abuse/Dependency, run by National Institute on Drug Abuse (NIDA) at 2 sites 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 7 inclusion and 10 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 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01037075, 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 16 Dec 2019.