CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 100 target
Drug / intervention
Nicotinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01034020
NCT01034020Phase 1Completed

Effects of Nicotine on Elements of Attentions in Smokers and Nonsmokers

National Institute on Drug Abuse (NIDA)·interventional·Posted Dec 17, 2009·Updated Jul 2, 2017

In Brief

A Phase 1 clinical trial evaluating Nicotine for Substance Related Disorder and Nicotine Dependence. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 17, 2009
Enrollment StartFeb 14, 2006
Primary CompletionNov 3, 2009
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 16.5 years ago

Interventions

Nicotinedrug