Ignite Creation Date:
2024-05-06 @ 4:00 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02420327
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2015-04-14
Brief Title:
Low-Dose Galantamine to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
The Use of Low-Dose Galantamine to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GalaNic
Brief Summary:
The aim of this study is to test whether the attention-enhancing effects of low-dose nicotine can be enhanced by the drug galantamine FDA-approved for the treatment of Alzheimers disease This proof-of-principle study is performed in healthy non-smokers and involves two single exposures to a nicotine patch 7 mg24 hrs and two single exposures to galantamine 4 mg The dose of galantamine is substantially lower than the clinical dose range of 16-24 mgday The hypothesis is that performance-enhancing effects of nicotine are greater in the presence of this low dose of galantamine
Detailed Description:
Healthy non-smokers will be screened for study eligibility and receive training on three different attention tasks Over four test session participants will then perform these tasks after receiving 1 a placebo patch and a placebo capsule 2 a nicotine patch 7 mg24 hrs and a placebo capsule 3 a placebo patch and a galantamine capsule and 4 a nicotine patch and a galantamine capsule The four test session are performed on separate days and take approximately 7 hours each During the first 5 hours the participant may read or watch TV while nicotine andor galantamine are being absorbed During the last two hours the participant will perform the attention tasks on a computer The investigators hypothesize that performance-enhancing effects of nicotine which were documented in previous research will be larger in the presence than in the absence of galantamine This proof-of-concept would have implications for the development of drugs for the treatment of conditions such as Alzheimers disease or schizophrenia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None