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Effects of Nicotine on Elements of Attentions in Smokers and Nonsmokers

Primary Purpose

Substance Related Disorder, Nicotine Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nicotine
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Related Disorder focused on measuring Nasal Spray, Attention Network Test, Continuous Performance Test, Attentional Blink Test

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

  • INCLUSION CRITERIA: Smokers

    1. be men and women 18-50 years old
    2. report smoking at least 15 cigarettes per day on average for at least 2 years
    3. have a urine cotinine level greater than or equl to 200 ng/ml
    4. have an estimated IQ score greater than or equal to 85

    5. be medically and psychologically healthy as determined by screening criteria

      EXCLUSION CRITERIA: Smokers

    1. be interested in reducing or quitting tobacco use
    2. have been treated for nicotine dependence in the past 3 months 3) report a history of drug or alcohol dependence

    4) report consumption of more than 15 alcoholic drinks per week during the past month

    5) report use of marijuana more than once per week during the past month

    6) report use of any illicit drug, other than marijuana, during the past 6 months

    7) be currently using any medication that would interfere with the protocol

    8) be under the influence of a drug or alcohol at experimental sessions

    9) be pregnant or nursing

    10) be HIV positive.

INCLUSION CRITERIA: Nonsmokers

  1. be men and women 18-50 years old
  2. report smoking less than 10 cigarettes in their life
  3. have a urine cotinine level less than 30 ng/ml
  4. have an estimated IQ score greater than or equal to 85
  5. be medically and psychologically healthy as determined by screening criteria

EXCLUSION CRITERIA: Nonsmokers

  1. report use of any tobacco products in the past 3 years
  2. report a history of drug or alcohol dependence
  3. report consumption of more than 15 alcoholic drinks per week during the past month
  4. report use of marijuana more than once per week during the past month
  5. report use of any illicit drug, other than marijuana, during the past 6 months
  6. be currently using any medication that would interfere with the protocol
  7. be under the influence of a drug or alcohol at experimental sessions
  8. be pregnant or nursing
  9. be HIV positive.

Sites / Locations

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

Outcomes

Primary Outcome Measures

Pharmacodynamics, changes in cognitive function

Secondary Outcome Measures

Changes in subjective mood, changes in cardiovascular measures

Full Information

First Posted
December 16, 2009
Last Updated
June 30, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01034020
Brief Title
Effects of Nicotine on Elements of Attentions in Smokers and Nonsmokers
Official Title
Effects of Nicotine on Elements of Attentions in Smokers and Nonsmokers
Study Type
Interventional

2. Study Status

Record Verification Date
September 22, 2010
Overall Recruitment Status
Completed
Study Start Date
February 14, 2006 (undefined)
Primary Completion Date
November 3, 2009 (Actual)
Study Completion Date
November 3, 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Related Disorder, Nicotine Dependence
Keywords
Nasal Spray, Attention Network Test, Continuous Performance Test, Attentional Blink Test

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nicotine
Primary Outcome Measure Information:
Title
Pharmacodynamics, changes in cognitive function
Secondary Outcome Measure Information:
Title
Changes in subjective mood, changes in cardiovascular measures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Smokers 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 EXCLUSION CRITERIA: Smokers 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 4) report consumption of more than 15 alcoholic drinks per week during the past month 5) report use of marijuana more than once per week during the past month 6) report use of any illicit drug, other than marijuana, during the past 6 months 7) be currently using any medication that would interfere with the protocol 8) be under the influence of a drug or alcohol at experimental sessions 9) be pregnant or nursing 10) be HIV positive. INCLUSION CRITERIA: Nonsmokers 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 EXCLUSION CRITERIA: Nonsmokers report use of any tobacco products in the past 3 years 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.
Facility Information:
Facility Name
National Institute on Drug Abuse, Biomedical Research Center (BRC)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11044746
Citation
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.
Results Reference
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PubMed Identifier
8453850
Citation
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.
Results Reference
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PubMed Identifier
15187577
Citation
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.
Results Reference
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Effects of Nicotine on Elements of Attentions in Smokers and Nonsmokers

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