Nicotinic Modulation of the Default Network of Resting Brain Function
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|ClinicalTrials.gov Identifier: NCT01240616|
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : April 5, 2018
|First Submitted Date||November 11, 2010|
|First Posted Date||November 15, 2010|
|Last Update Posted Date||April 5, 2018|
|Study Start Date||October 24, 2010|
|Primary Completion Date||Not Provided|
|Current Primary 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.|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01240616 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Nicotinic Modulation of the Default Network of Resting Brain Function|
|Official Title||Nicotinic Modulation of the Default Network of Resting Brain Function|
- 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.
- 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.
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|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Study Completion Date||December 24, 2014|
|Primary Completion Date||Not Provided|
|Ages||21 Years to 55 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||999911461
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Institute on Drug Abuse (NIDA)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 24, 2014|