SchizophreniaNCT01369966
Brain Circuits in Schizophrenia and Smoking
An observational study of Schizophrenia and Smoking Cessation, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: Smoking is associated with serious health risks. People who have mental illness are more likely to smoke. Researchers are studying the brain circuits linked with smoking and nicotine craving. Read more about this study
- Who is it for?
- Ages 18 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Smoking Cessation, Nicotine Abuse
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2011to 24 Dec 2014
- 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 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For all participants (patients, healthy controls, and family members):
- Male and Female between ages 18-62
- Ability to give written informed consent
- For patients (smokers and non-smokers)
- Must have a DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder.
- Must be clinically stable in the opinion of the patient s treating clinician with no change in antipsychotic medications or any dosage adjustment for 2 weeks or more preceding study enrollment as well as 2 weeks or more prior to each of the MRI scans.
Show all 10Show fewer
- For smokers (patients, healthy controls, and family members):
- 1. Must have smoked at least 100 cigarettes in the last year and currently smoking daily (at any amount).
- For family members only:
- 1. Have a least one first-degree family member who is eligible for participating in this protocol as a patient or a smoker as defined above
Who cannot join
- For patients only:
- 1. Evaluation to Sign Consent (ESC) score below 12.
- For all participants (patients and healthy controls):
- Any medical illnesses that may affect normal brain functioning, based on the screening history. Examples of these conditions include, but not limited to, stroke, repeated seizure, history of significant head trauma, CNS infection or tumor, other significant brain neurological conditions.
- Substance dependence within 6 months or substance abuse within 1 month, other than nicotine or marijuana dependence.
- Pregnancy
Show all 11Show fewer
- Cannot refrain from using alcohol and marijuana for 24 hours
- Unable to safely undergo MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted or non-removable metal parts), claustrophobic to the scanner, or unable to lie comfortably supine for up to 2 hours
- Cannot safely give 70 ml blood based on the screening evaluation
- For family members:
- Family members meeting exclusion criteria 1-5 above may participate in the study unless they cannot safely give 70 ml blood. Their participation will, however, be limited to research interviews and questionnaires and phlebotomy or saliva collection for genetic testing.
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:
- Smoking is associated with serious health risks. People who have mental illness are more likely to smoke. Researchers are studying the brain circuits linked with smoking and nicotine craving. This study will look at whether a specific brain circuit can explain the high rate of smoking in people with schizophrenia.
Read more
Objectives:
- To study brain activity in smokers and nonsmokers with and without schizophrenia, as well as their family members.
Eligibility:
- Current smokers (at least 100 cigarettes in the past year) and nonsmokers between 18 and 62 years of age in one of the following groups:
- Have been diagnosed with schizophrenia.
- Family members of those with schizophrenia.
- Healthy adults with no history of severe mental illness or brain trauma.
- Family members of the healthy adults.
Design:
- People in the study will be screened with a physical exam, medical history, questionnaires, and blood tests.
- They will have up to three visits: the screening visit and two study visits (each given 1 year apart).
- At the first study visit, those taking part will be trained in the tests they will do during the magnetic resonance imaging (MRI) scan. Then they will have the MRI scan.
- After the first study visit, current smokers will receive phone calls from the study researchers every other month for 1 year. They will be asked about their smoking habits.
- At the second study visit, current smokers and some nonsmokers will have another MRI scan and the same tests as before.
- Current smokers will receive a final phone call 1 year after the second study visit. They will be asked to give information about their smoking habits.
Read the detailed description
Objective
The health risk associated with tobacco use is high, and is even higher in people with severe mental illness. The underlying brain circuitry for smoking-mental illness comorbidity is unknown. Identifying brain comorbidity circuitry is important for new therapeutic development. This study will examine whether a specific brain circuitry can explain the high rate of smoking in patients with schizophrenia. Identifying the key brain circuits associated with smoking, especially smoking in a high risk population, will provide concrete biomarkers for new therapeutic development, and ultimately reducing the smoking related health burden.
Study Population
Schizophrenic patients and their family members, non-schizophrenia controls and their family members, including smokers and nonsmokers in each of the four groups will be included in this study.
Design
- A cross-sectional study for all subjects at baseline. They will receive clinical and diagnostic interviews, functional, symptom, and cognitive testing, and MRI. They will also have blood drawn, to identify brain circuits and covariates associated with the severe smoking problem in schizophrenia.
- A prospective longitudinal study design where smokers will be encouraged to quit smoking and smoking cessation support is provided if needed, followed by retesting of imaging and some clinical assessments, to identify brain circuits associated smoking cessation or the difficulty of quitting in schizophrenia and non-schizophrenia smokers.
Outcome Measures
Combining event-related and resting fMRI techniques, we propose to test the hypothesis that an abnormal dorsal anterior cingulate cortex (dACC) and ventral striatum (VS) circuit underlies the high prevalence of comorbid smoking in schizophrenia. We also propose to test specific clinical implications of this circuit including a within-subject event-related fMRI study to test the mechanistic implication of the rsFC signals, a prospective follow-up to test the circuit s predictive validity on smoking behavior change, and genetic studies to describe the path from genes to brain circuits to smoking behaviors.
- Conditions
- Schizophrenia, Smoking Cessation, Nicotine Abuse
- Keywords
- Smoking Cessation, Schizophrenic Smokers, fMRI, Neural Circuits
- Medical subject headings
- Schizophrenia, Smoking Cessation
What is being measured
The primary outcome is the main question the study is designed to answer.
Test the hypothesis that dorsal anterior cingulate cortex - ventral straitum (dACC-VS) resting state functional connectivity (rsFC) is related to smoking in NC smokers and NC nonsmokers.
Secondary outcomes (2)
Test the hypothesis that dACC-VS rsFC is associated with SZ by comparing SZ smokers and SZ nonsmokers with NCs above. First-degree relatives of SZ smokers will be included to rule out medication effects.
Examine the mechanistic implication of the rsFC measure using parallel resting & behavioral/cognitive task based fMRI; compare fMRI signals and test the hypothesis that reward/inhibition nodes/circuits and rsFC are associated with aspect...
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study start16 May 2011
- Study completion24 Dec 2014
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
- Time perspective
- Other
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Elliot Stein, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369966
- Sponsor's protocol ID
- 999911467
- Other IDs
- 11-DA-N467
- Status last verified
- 24 Dec 2014
- First submitted
- 8 Jun 2011
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Abi-Dargham A, Gil R, Krystal J, Baldwin RM, Seibyl JP, Bowers M, van Dyck CH, Charney DS, Innis RB, Laruelle M. Increased striatal dopamine transmission in schizophrenia: confirmation in a second cohort. Am J Psychiatry. 1998 Jun;155(6):761-7. doi: 10.1176/ajp.155.6.761.
PubMed 9619147Aguilar MC, Gurpegui M, Diaz FJ, de Leon J. Nicotine dependence and symptoms in schizophrenia: naturalistic study of complex interactions. Br J Psychiatry. 2005 Mar;186:215-21. doi: 10.1192/bjp.186.3.215.
PubMed 15738502al'Absi M, Hatsukami D, Davis GL. Attenuated adrenocorticotropic responses to psychological stress are associated with early smoking relapse. Psychopharmacology (Berl). 2005 Aug;181(1):107-17. doi: 10.1007/s00213-005-2225-3. Epub 2005 Apr 15.
PubMed 15834539
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
- Brain Circuits in Schizophrenia and Smoking
- ClinicalTrials.gov ID
- NCT01369966
- Acronym / sponsor ID
- 999911467
- Conditions
- Schizophrenia, Smoking Cessation, Nicotine Abuse
- Keywords
- Smoking Cessation, Schizophrenic Smokers, fMRI, Neural Circuits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 16 May 2011
- Study completion
- 24 Dec 2014
- First posted
- 9 Jun 2011 (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:
- Smoking is associated with serious health risks. People who have mental illness are more likely to smoke. Researchers are studying the brain circuits linked with smoking and nicotine craving. This study will look at whether a specific brain circuit can explain the high rate of smoking in people with schizophrenia.
Objectives:
- To study brain activity in smokers and nonsmokers with and without schizophrenia, as well as their family members.
Eligibility:
- Current smokers (at least 100 cigarettes in the past year) and nonsmokers between 18 and 62 years of age in one of the following groups:
- Have been diagnosed with schizophrenia.
- Family members of those with schizophrenia.
- Healthy adults with no history of severe mental illness or brain trauma.
- Family members of the healthy adults.
Design:
- People in the study will be screened with a physical exam, medical history, questionnaires, and blood tests.
- They will have up to three visits: the screening visit and two study visits (each given 1 year apart).
- At the first study visit, those taking part will be trained in the tests they will do during the magnetic resonance imaging (MRI) scan. Then they will have the MRI scan.
- After the first study visit, current smokers will receive phone calls from the study researchers every other month for 1 year. They will be asked about their smoking habits.
- At the second study visit, current smokers and some nonsmokers will have another MRI scan and the same tests as before.
- Current smokers will receive a final phone call 1 year after the second study visit. They will be asked to give information about their smoking habits.
Detailed description
Objective
The health risk associated with tobacco use is high, and is even higher in people with severe mental illness. The underlying brain circuitry for smoking-mental illness comorbidity is unknown. Identifying brain comorbidity circuitry is important for new therapeutic development. This study will examine whether a specific brain circuitry can explain the high rate of smoking in patients with schizophrenia. Identifying the key brain circuits associated with smoking, especially smoking in a high risk population, will provide concrete biomarkers for new therapeutic development, and ultimately reducing the smoking related health burden.
Study Population
Schizophrenic patients and their family members, non-schizophrenia controls and their family members, including smokers and nonsmokers in each of the four groups will be included in this study.
Design
- A cross-sectional study for all subjects at baseline. They will receive clinical and diagnostic interviews, functional, symptom, and cognitive testing, and MRI. They will also have blood drawn, to identify brain circuits and covariates associated with the severe smoking problem in schizophrenia.
- A prospective longitudinal study design where smokers will be encouraged to quit smoking and smoking cessation support is provided if needed, followed by retesting of imaging and some clinical assessments, to identify brain circuits associated smoking cessation or the difficulty of quitting in schizophrenia and non-schizophrenia smokers.
Outcome Measures
Combining event-related and resting fMRI techniques, we propose to test the hypothesis that an abnormal dorsal anterior cingulate cortex (dACC) and ventral striatum (VS) circuit underlies the high prevalence of comorbid smoking in schizophrenia. We also propose to test specific clinical implications of this circuit including a within-subject event-related fMRI study to test the mechanistic implication of the rsFC signals, a prospective follow-up to test the circuit s predictive validity on smoking behavior change, and genetic studies to describe the path from genes to brain circuits to smoking behaviors.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male and Female between ages 18-62
- Ability to give written informed consent
- For patients (smokers and non-smokers)
- Must have a DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder.
- Must be clinically stable in the opinion of the patient s treating clinician with no change in antipsychotic medications or any dosage adjustment for 2 weeks or more preceding study enrollment as well as 2 weeks or more prior to each of the MRI scans.
Key exclusion criteria (11 listed)
- 1. Evaluation to Sign Consent (ESC) score below 12.
- Any medical illnesses that may affect normal brain functioning, based on the screening history. Examples of these conditions include, but not limited to, stroke, repeated seizure, history of significant head trauma, CNS infection or tumor, other significant brain neurological conditions.
- Substance dependence within 6 months or substance abuse within 1 month, other than nicotine or marijuana dependence.
- Pregnancy
- Cannot refrain from using alcohol and marijuana for 24 hours
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
Test the hypothesis that dorsal anterior cingulate cortex - ventral straitum (dACC-VS) resting state functional connectivity (rsFC) is related to smoking in NC smokers and NC nonsmokers.
2 secondary outcomes
Test the hypothesis that dACC-VS rsFC is associated with SZ by comparing SZ smokers and SZ nonsmokers with NCs above. First-degree relatives of SZ smokers will be included to rule out medication effects.
Examine the mechanistic implication of the rsFC measure using parallel resting & behavioral/cognitive task based fMRI; compare fMRI signals and test the hypothesis that reward/inhibition nodes/circuits and rsFC are associated with aspect...
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 9619147Abi-Dargham A, Gil R, Krystal J, Baldwin RM, Seibyl JP, Bowers M, van Dyck CH, Charney DS, Innis RB, Laruelle M. Increased striatal dopamine transmission in schizophrenia: confirmation in a second cohort. Am J Psychiatry. 1998 Jun;155(6):761-7. doi: 10.1176/ajp.155.6.761.
- Background: PubMed 15738502Aguilar MC, Gurpegui M, Diaz FJ, de Leon J. Nicotine dependence and symptoms in schizophrenia: naturalistic study of complex interactions. Br J Psychiatry. 2005 Mar;186:215-21. doi: 10.1192/bjp.186.3.215.
- Background: PubMed 15834539al'Absi M, Hatsukami D, Davis GL. Attenuated adrenocorticotropic responses to psychological stress are associated with early smoking relapse. Psychopharmacology (Berl). 2005 Aug;181(1):107-17. doi: 10.1007/s00213-005-2225-3. Epub 2005 Apr 15.
Related trials for Schizophrenia
RecruitingPhase 1
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Schizophrenia
Not yet recruiting
NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia
Schizophrenia, Schizoaffective Disorder
Active, not recruiting
The Acupuncture Treatment Effect in Patients With Schizophrenia
Mental Health
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
Psychotic Disorders, Alzheimer Disease
Not yet recruitingObservational study
Real-World Impact of TV-44749 in Adults With Schizophrenia
Schizophrenia
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 Schizophrenia and Smoking Cessation, 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 10 inclusion and 11 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?
Test the hypothesis that dorsal anterior cingulate cortex - ventral straitum (dACC-VS) resting state functional connectivity (rsFC) is related to smoking in NC smokers and NC nonsmokers.. 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 NCT01369966, 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.