Ignite Creation Date:
2024-05-06 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03416569
Status:
WITHDRAWN
Last Update Posted:
2019-08-19
First Post:
2018-01-24
Brief Title:
Effects of Prazosin on the Attention-Enhancing Effects of Nicotine
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
The Effects of Prazosin on the Attention-Enhancing Effects of Nicotine in Healthy Non-Smokers
Status:
WITHDRAWN
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unanticipated staff changes are preventing completion within funding period
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To test whether specific aspects of the attention-enhancing effects of nicotine may be mediated by down-stream activation of alpha1 adrenoceptors the interaction of nicotine and the alpha1 adrenergic antagonist prazosin on cognitive task performance will be tested in human non-smokers The effects of a low-dose nicotine patch vs a placebo patch will be tested in the presence and absence of prazosin over 4 test sessions
Detailed Description:
Drugs that activate nicotinic acetylcholine receptors nAChRs such as nicotine have cognitive enhancing and in particular attention-enhancing effects that may be of clinical benefit to individuals with cognitive deficits such as those diagnosed with Alzheimers disease schizophrenia or ADHD nAChR agonists can increase the release of other neurotransmitters in the brain including dopamine noradrenaline serotonin glutamate and GABA To date it is unknown which of these actions is central to mediating the attention-enhancing effects of nAChR agonists Such knowledge would channel drug development efforts onto subtypes of the nAChR expressed on and activating the target system but not systems such as the subcortical dopamine system involved in unwanted effects of nAChR agonists eg dependence
Preclinical studies have suggested that the noradrenergic system is critical to the attention-enhancing effects of the prototypical nAChR agonist nicotine Activation of alpha1-adrenergic receptors appears to be involved in broadening the attentional window an effect shared with nicotine The aim of the present study is to test whether the effects of nicotine on broad monitoring may be mediated by alpha1 adrenoceptors by testing the interaction of nicotine and the predominantly alpha1 adrenergic antagonist prazosin in healthy human non-smokers The effects of a low-dose nicotine patch vs a placebo patch will be tested in the presence and absence of prazosin in a 2 x 2 within-subject design over 4 repeated test sessions in healthy never-smokers Each participant is asked to complete for test session on separate days In each session a skin patch will be applied and a capsule given by mouth In one session both are a placebo In another session the patch contains nicotine 7 mg24 hrs and the capsule is a placebo In another session the patch is a placebo and the capsule contains 1 mg of prazosin In another session the patch contains nicotine and the capsule contains prazosin The sequence of these testing conditions is counterbalanced and double-blind
Preclinical studies have suggested that the noradrenergic system is critical to the attention-enhancing effects of the prototypical nAChR agonist nicotine Activation of alpha1-adrenergic receptors appears to be involved in broadening the attentional window an effect shared with nicotine The aim of the present study is to test whether the effects of nicotine on broad monitoring may be mediated by alpha1 adrenoceptors by testing the interaction of nicotine and the predominantly alpha1 adrenergic antagonist prazosin in healthy human non-smokers The effects of a low-dose nicotine patch vs a placebo patch will be tested in the presence and absence of prazosin in a 2 x 2 within-subject design over 4 repeated test sessions in healthy never-smokers Each participant is asked to complete for test session on separate days In each session a skin patch will be applied and a capsule given by mouth In one session both are a placebo In another session the patch contains nicotine 7 mg24 hrs and the capsule is a placebo In another session the patch is a placebo and the capsule contains 1 mg of prazosin In another session the patch contains nicotine and the capsule contains prazosin The sequence of these testing conditions is counterbalanced and double-blind
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None