Status:
COMPLETED
Nicotinic Modulation of the Default Network of Resting Brain Function
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Nicotine Dependence
Eligibility:
All Genders
21-55 years
Brief 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. Previous re...
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,...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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).
- EXCLUSION CRITERIA:
- 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).
- 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.
Exclusion
Key Trial Info
Start Date :
October 24 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 24 2014
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01240616
Start Date
October 24 2010
End Date
December 24 2014
Last Update
July 5 2018
Active Locations (2)
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1
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, United States, 21224
2
University of Maryland at Baltimore/MPRC
Catonsville, Maryland, United States, 21228