Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT01034020
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2009-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Nicotine on Elements of Attentions in Smokers and Nonsmokers
Sponsor:
National Institute on Drug Abuse (NIDA)
Organization:
Study Overview
Official Title:
Effects of Nicotine on Elements of Attentions in Smokers and Nonsmokers
Status:
COMPLETED
Status Verified Date:
2010-09-22
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:
None
Brief Summary:
Background:
\- Many cigarette smokers claim that smoking helps them stay alert and improves their concentration, and have reported problems in attention and concentration after quitting smoking. Some research has indicated that nicotine can enhance certain aspects of attention and memory in humans. However, more research is needed to determine how nicotine affects different elements of the brain's ability to pay attention. Knowing which aspects of attention are affected by nicotine may help produce new medications and therapies to help people successfully stop smoking.
Objectives:
* To investigate the dose-related effects of nicotine on the ability to pay attention in smokers and nonsmokers.
* To compare the effects of nicotine in smokers and nonsmokers.
Eligibility:
\- Individuals between 18 and 50 years of age who are either current smokers (at least 15 cigarettes per day on average for at least 2 years) or healthy, nonsmoking volunteers.
Design:
* The study will consist of one training session and three testing sessions. Each session will last about 2 hours.
* The training session will introduce participants to the study tests and evaluate their tolerance of the two levels of nicotine nasal spray used in the study. Smokers will receive the higher dose of nicotine to introduce them to the effects of the spray. Nonsmokers will be given first the lower dose of the spray, followed by higher dose at least 30 minutes later. Nonsmoking participants who cannot tolerate the higher dose will not continue in the study.
* At the start of each testing session, smokers will have one cigarette to standardize the time of the most recent exposure to nicotine.
* During the testing sessions, participants will receive a placebo spray, a lower dose of nicotine, or a higher dose of nicotine, and then will be asked to perform tests that evaluate mood, attention, and performance.
\- Many cigarette smokers claim that smoking helps them stay alert and improves their concentration, and have reported problems in attention and concentration after quitting smoking. Some research has indicated that nicotine can enhance certain aspects of attention and memory in humans. However, more research is needed to determine how nicotine affects different elements of the brain's ability to pay attention. Knowing which aspects of attention are affected by nicotine may help produce new medications and therapies to help people successfully stop smoking.
Objectives:
* To investigate the dose-related effects of nicotine on the ability to pay attention in smokers and nonsmokers.
* To compare the effects of nicotine in smokers and nonsmokers.
Eligibility:
\- Individuals between 18 and 50 years of age who are either current smokers (at least 15 cigarettes per day on average for at least 2 years) or healthy, nonsmoking volunteers.
Design:
* The study will consist of one training session and three testing sessions. Each session will last about 2 hours.
* The training session will introduce participants to the study tests and evaluate their tolerance of the two levels of nicotine nasal spray used in the study. Smokers will receive the higher dose of nicotine to introduce them to the effects of the spray. Nonsmokers will be given first the lower dose of the spray, followed by higher dose at least 30 minutes later. Nonsmoking participants who cannot tolerate the higher dose will not continue in the study.
* At the start of each testing session, smokers will have one cigarette to standardize the time of the most recent exposure to nicotine.
* During the testing sessions, participants will receive a placebo spray, a lower dose of nicotine, or a higher dose of nicotine, and then will be asked to perform tests that evaluate mood, attention, and performance.
Detailed Description:
Objective: The primary objective of this study is to investigate the dose-related effects of nicotine on various elements of attention in smokers and nonsmokers. Because no published study, to our knowledge, has reported the effects of nicotine on the ANT and ABT, we will include the CPT, a task shown to be sensitive to nicotine, as a positive control. A secondary aim is to compare the subjective and physiological effects of nicotine between smokers and nonsmokers.
Study Population: 50 smokers for a total of 30 completers (15 women, 15 men) and up to 50 nonsmokers for a total of 30 completers (15 women, 15 men).
Design: Placebo-controlled, between-groups comparison of smokers and nonsmokers. Participants will attend three experiemental sessions; a single dose of nicotine nasal spray (0, 0.5, or 1.5 mg) will be administered at each session.
Outcome Measures: Primary outcome measures will be accuracy and/or response time on the three attention tests, ANT, CPT, and ABT. Secondary outcome measures include responses to the PANAS, VAS items, and vital signs (heart rate and blood pressure). Participant demographics and smoking history will be reported using descriptive statistics.
Study Population: 50 smokers for a total of 30 completers (15 women, 15 men) and up to 50 nonsmokers for a total of 30 completers (15 women, 15 men).
Design: Placebo-controlled, between-groups comparison of smokers and nonsmokers. Participants will attend three experiemental sessions; a single dose of nicotine nasal spray (0, 0.5, or 1.5 mg) will be administered at each session.
Outcome Measures: Primary outcome measures will be accuracy and/or response time on the three attention tests, ANT, CPT, and ABT. Secondary outcome measures include responses to the PANAS, VAS items, and vital signs (heart rate and blood pressure). Participant demographics and smoking history will be reported using descriptive statistics.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 06-DA-N409 | None | None | View |