Nicotine DependenceNCT01240616
Nicotinic Modulation of the Default Network of Resting Brain Function
An observational study of Nicotine Dependence, run by National Institute on Drug Abuse (NIDA) at 2 sites in United States.
Trial summary
Background: A brain circuit called the default network is the brain circuit that is active when the brain is at rest; that is, when individuals are not concentrating on specific tasks. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Oct 2010to 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 21 through 55. We want to avoid exposing a maturing brain to centrally active substances that it has not previously been exposed to (non-smokers), and to increase sensitivity for measuring drug effects by minimizing population inhomogeneity related to both cognitive decline with normal aging (Verhaeghen and Salthouse 1997, De Luca et al. 2003) and to ongoing brain maturation.
- Did not consume cigarettes, cigarillos, cigars, or other tobacco or nicotine-containing products more than 20 times in lifetime, and did not use any nicotine-containing product at all within the last two years.
- Normal or corrected to normal vision (at least 20/80).
Who cannot join
- Presence of metal objects in the body, implanted electronic devices, or any other counter indication for MRI.
- Claustrophobia.
- Major psychiatric disorders including mood, anxiety or psychotic disorders.
- Cardiovascular or cerebrovascular disease, such as history of myocardial infarction, heart failure, angina, stroke, severe arrhythmias, or EKG abnormalities as specified under Screening methods .
- Kidney or liver disease.
- Hypertension (resting systolic BP above 140 or diastolic above 85 mm Hg).
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- Hypotension (resting systolic BP below 95 or diastolic below 60).
- Use of any prescription or over-the-counter drug other than supplements and birth control.
- History of or current neurological illnesses, such as stroke, seizures, dementia or organic brain syndrome.
- Learning disability, attention deficit disorder, or any other condition that impedes memory and attention.
- Glaucoma, organic pyloric stenosis, uremia or renal insufficiency (see Mecamylamine-related risks).
- Prostatic hypertrophy, bladder neck obstruction or urethral stricture (see Mecamylamine-related risks).
- Left-handed or ambidextrous.
- Pregnant as determined by urine test, or breast-feeding.
- History or current diagnosis of drug or alcohol abuse or dependence.
- IQ < 85 as estimated by the WASI vocabulary subtest.
- Strong disposition to get car sick.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, 21224
University of Maryland at Baltimore/MPRC
Catonsville, Maryland, 21228
About this study
Background:
- A brain circuit called the default network is the brain circuit that is active when the brain is at rest; that is, when individuals are not concentrating on specific tasks. Previous research has shown that the default network functions differently in people with schizophrenia and Alzheimer s disease, and may contribute to the problems with memory and concentration that can affect people who have these conditions. Studies have also shown that nicotine affects the default network, but more research is needed on the ways in which nicotinic receptors may change activity in these regions and thereby affect individuals ability to concentrate on specific tasks.
Read more
Objectives:
- To determine whether and how nicotine and mecamylamine, a drug that blocks nicotinic receptors, affect the default network in nonsmokers in ways that improve thinking and concentration.
Eligibility:
- Healthy, right-handed volunteers between 21 and 50 years of age.
- Volunteers must not have used any kind of tobacco product in the past 2 years.
Design:
- This study involves an initial screening visit, a training visit, and three testing visits.
- Participants will be screened with a medical history and physical examination, as well as blood and urine samples and questions about smoking history.
- Participants will have an initial training session to practice the tasks that will be done during magnetic resonance imaging scans at the testing visits. These tasks will test participants concentration and memory.
- Participants will have three test sessions with the following combinations of study drugs: (1) a nicotine patch and a placebo capsule, (2) a placebo patch and a capsule of mecamylamine, or (3) a placebo patch and capsule. Different combinations will be given at each visit, and participants will not know which one they receive.
- Participants will perform the same concentration and memory tasks at each testing visit, and will provide a blood sample after each visit to determine levels of nicotine and mecamylamine.
Read the detailed description
Objective: To evaluate the potential of manipulating activity in the so-called default network of resting brain function by nicotinic ligands. Default network activity modulates cognitive functioning, and effects of nicotine thereon may motivate smoking behavior. In the future, this mechanism could become a novel approach to improving cognition in disease populations that show dysfunction of this network, such as schizophrenia or Alzheimer s disease.
Study population: 27 healthy non-smokers.
Design: A double-blind, placebo-controlled, within-subject fMRI study, evaluating regional brain activation and cognitive functions under conditions of transdermal nicotine (7 mg/day), oral mecamylamine (a nicotinic antagonist, 7.5 mg), and placebo.
Outcome measures: Activity and functional connectivity of default regions during cognitive task performance, measures of cognitive task performance, measures of subjective state, and plasma concentrations of nicotine, nicotine metabolites and mecamylamine.
- Conditions
- Nicotine Dependence
- Keywords
- Nicotine, Mecamylamine, Attention, fMRI, Default Network, Healthy Volunteer, HV
- Medical subject headings
- Tobacco Use Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity and functional connectivity of default regions during cognitive task performance, measures of cognitive task performance, measures of subjective state, and plasma concentrations of nicotine, nicotine metabolites and mecamylamine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study start24 Oct 2010
- 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 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
- Prospective
- Enrolment
- 43 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
- NCT01240616
- Sponsor's protocol ID
- 999911461
- Other IDs
- 11-DA-N461
- Status last verified
- 24 Dec 2014
- First submitted
- 11 Nov 2010
- Last updated
- 5 Jul 2018
- Results posted
- No
Publications
Binder JR, Frost JA, Hammeke TA, Bellgowan PS, Rao SM, Cox RW. Conceptual processing during the conscious resting state. A functional MRI study. J Cogn Neurosci. 1999 Jan;11(1):80-95. doi: 10.1162/089892999563265.
PubMed 9950716Bluhm RL, Miller J, Lanius RA, Osuch EA, Boksman K, Neufeld RW, Theberge J, Schaefer B, Williamson P. Spontaneous low-frequency fluctuations in the BOLD signal in schizophrenic patients: anomalies in the default network. Schizophr Bull. 2007 Jul;33(4):1004-12. doi: 10.1093/schbul/sbm052. Epub 2007 Jun 7.
PubMed 17556752Boyajian RA, Otis SM. Acute effects of smoking on human cerebral blood flow: a transcranial Doppler ultrasonography study. J Neuroimaging. 2000 Oct;10(4):204-8. doi: 10.1111/jon2000104204.
PubMed 11147398
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotinic Modulation of the Default Network of Resting Brain Function
- ClinicalTrials.gov ID
- NCT01240616
- Acronym / sponsor ID
- 999911461
- Conditions
- Nicotine Dependence
- Keywords
- Nicotine, Mecamylamine, Attention, fMRI, Default Network, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 24 Oct 2010
- Study completion
- 24 Dec 2014
- First posted
- 15 Nov 2010 (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:
- A brain circuit called the default network is the brain circuit that is active when the brain is at rest; that is, when individuals are not concentrating on specific tasks. Previous research has shown that the default network functions differently in people with schizophrenia and Alzheimer s disease, and may contribute to the problems with memory and concentration that can affect people who have these conditions. Studies have also shown that nicotine affects the default network, but more research is needed on the ways in which nicotinic receptors may change activity in these regions and thereby affect individuals ability to concentrate on specific tasks.
Objectives:
- To determine whether and how nicotine and mecamylamine, a drug that blocks nicotinic receptors, affect the default network in nonsmokers in ways that improve thinking and concentration.
Eligibility:
- Healthy, right-handed volunteers between 21 and 50 years of age.
- Volunteers must not have used any kind of tobacco product in the past 2 years.
Design:
- This study involves an initial screening visit, a training visit, and three testing visits.
- Participants will be screened with a medical history and physical examination, as well as blood and urine samples and questions about smoking history.
- Participants will have an initial training session to practice the tasks that will be done during magnetic resonance imaging scans at the testing visits. These tasks will test participants concentration and memory.
- Participants will have three test sessions with the following combinations of study drugs: (1) a nicotine patch and a placebo capsule, (2) a placebo patch and a capsule of mecamylamine, or (3) a placebo patch and capsule. Different combinations will be given at each visit, and participants will not know which one they receive.
- Participants will perform the same concentration and memory tasks at each testing visit, and will provide a blood sample after each visit to determine levels of nicotine and mecamylamine.
Detailed description
Objective: To evaluate the potential of manipulating activity in the so-called default network of resting brain function by nicotinic ligands. Default network activity modulates cognitive functioning, and effects of nicotine thereon may motivate smoking behavior. In the future, this mechanism could become a novel approach to improving cognition in disease populations that show dysfunction of this network, such as schizophrenia or Alzheimer s disease.
Study population: 27 healthy non-smokers.
Design: A double-blind, placebo-controlled, within-subject fMRI study, evaluating regional brain activation and cognitive functions under conditions of transdermal nicotine (7 mg/day), oral mecamylamine (a nicotinic antagonist, 7.5 mg), and placebo.
Outcome measures: Activity and functional connectivity of default regions during cognitive task performance, measures of cognitive task performance, measures of subjective state, and plasma concentrations of nicotine, nicotine metabolites and mecamylamine.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
Key exclusion criteria (17 listed)
- Presence of metal objects in the body, implanted electronic devices, or any other counter indication for MRI.
- Claustrophobia.
- Major psychiatric disorders including mood, anxiety or psychotic disorders.
- Cardiovascular or cerebrovascular disease, such as history of myocardial infarction, heart failure, angina, stroke, severe arrhythmias, or EKG abnormalities as specified under Screening methods .
- Kidney or liver disease.
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
Activity and functional connectivity of default regions during cognitive task performance, measures of cognitive task performance, measures of subjective state, and plasma concentrations of nicotine, nicotine metabolites and mecamylamine.
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 Jul 2018.
- Background: PubMed 9950716Binder JR, Frost JA, Hammeke TA, Bellgowan PS, Rao SM, Cox RW. Conceptual processing during the conscious resting state. A functional MRI study. J Cogn Neurosci. 1999 Jan;11(1):80-95. doi: 10.1162/089892999563265.
- Background: PubMed 17556752Bluhm RL, Miller J, Lanius RA, Osuch EA, Boksman K, Neufeld RW, Theberge J, Schaefer B, Williamson P. Spontaneous low-frequency fluctuations in the BOLD signal in schizophrenic patients: anomalies in the default network. Schizophr Bull. 2007 Jul;33(4):1004-12. doi: 10.1093/schbul/sbm052. Epub 2007 Jun 7.
- Background: PubMed 11147398Boyajian RA, Otis SM. Acute effects of smoking on human cerebral blood flow: a transcranial Doppler ultrasonography study. J Neuroimaging. 2000 Oct;10(4):204-8. doi: 10.1111/jon2000104204.
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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)
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 Nicotine Dependence, 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 3 inclusion and 17 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 Jul 2018. 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.
What does the primary outcome measure?
Activity and functional connectivity of default regions during cognitive task performance, measures of cognitive task performance, measures of subjective state, and plasma concentrations of nicotine, nicotine metabolites and mecamylamine.. 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 NCT01240616, 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 Jul 2018.