Effects of Nicotine on Elements of Attentions in Smokers and Nonsmokers

NCT01034020 | Completed Phase 1

• 2 other identifiers: 99990640906-DA-N409
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Related Disorder; Nicotine Dependence

Keywords

Nasal Spray; Attention Network Test; Continuous Performance Test; Attentional Blink Test

Outcome Measures

Primary Outcomes (1)

• Pharmacodynamics, changes in cognitive function

Secondary Outcomes (1)

• Changes in subjective mood, changes in cardiovascular measures

Interventions

Nicotine DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• be men and women 18-50 years old
• report smoking at least 15 cigarettes per day on average for at least 2 years
• have a urine cotinine level greater than or equl to 200 ng/ml
• have an estimated IQ score greater than or equal to 85
• be medically and psychologically healthy as determined by screening criteria

You may not qualify if:

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• be interested in reducing or quitting tobacco use
• have been treated for nicotine dependence in the past 3 months 3) report a history of drug or alcohol dependence
• \) report consumption of more than 15 alcoholic drinks per week during the past month
• \) report use of marijuana more than once per week during the past month
• \) report use of any illicit drug, other than marijuana, during the past 6 months
• \) be currently using any medication that would interfere with the protocol
• \) be under the influence of a drug or alcohol at experimental sessions
• \) be pregnant or nursing
• \) be HIV positive.
• be men and women 18-50 years old
• report smoking less than 10 cigarettes in their life
• have a urine cotinine level less than 30 ng/ml
• have an estimated IQ score greater than or equal to 85
• be medically and psychologically healthy as determined by screening criteria

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse, Biomedical Research Center (BRC)

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

• Bancroft A, Levin ED. Ventral hippocampal alpha4beta2 nicotinic receptors and chronic nicotine effects on memory. Neuropharmacology. 2000 Oct;39(13):2770-8. doi: 10.1016/s0028-3908(00)00099-x.

  PMID: 11044746 BACKGROUND

• Benowitz NL, Jacob P 3rd. Nicotine and cotinine elimination pharmacokinetics in smokers and nonsmokers. Clin Pharmacol Ther. 1993 Mar;53(3):316-23. doi: 10.1038/clpt.1993.27.

  PMID: 8453850 BACKGROUND

• Bizarro L, Patel S, Murtagh C, Stolerman IP. Differential effects of psychomotor stimulants on attentional performance in rats: nicotine, amphetamine, caffeine and methylphenidate. Behav Pharmacol. 2004 May;15(3):195-206.

  PMID: 15187577 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders; Tobacco Use Disorder

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: February 14, 2006
• Primary Completion: November 3, 2009
• Study Completion: November 3, 2009
• Last Updated: July 2, 2017

Record last verified: 2010-09-22

Locations

US (1)