Substance Related DisorderPhase 1NCT01034020
Effects of Nicotine on Elements of Attentions in Smokers and Nonsmokers
A Phase 1 study testing Nicotine in people with Substance Related Disorder and Nicotine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Substance Related Disorder, Nicotine Dependence
- What is being tested?
- Nicotine
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2006to 3 Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- be men and women 18-50 years old
Show all 10Show fewer
- 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
Who cannot join
- <!-- -->
- 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
Show all 19Show fewer
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, 21224
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Substance Related Disorder, Nicotine Dependence
- Being tested
- Nicotine
- Keywords
- Nasal Spray, Attention Network Test, Continuous Performance Test, Attentional Blink Test
- Medical subject headings
- Substance-Related Disorders, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics, changes in cognitive function
Secondary outcomes (1)
Changes in subjective mood, changes in cardiovascular measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study start14 Feb 2006
- Primary completion3 Nov 2009
- Study completion3 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Substance Related DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034020
- Sponsor's protocol ID
- 999906409
- Other IDs
- 06-DA-N409
- Status last verified
- 22 Sep 2010
- First submitted
- 16 Dec 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 11044746Benowitz 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.
PubMed 8453850Bizarro 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.
PubMed 15187577
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nicotine on Elements of Attentions in Smokers and Nonsmokers
- ClinicalTrials.gov ID
- NCT01034020
- Acronym / sponsor ID
- 999906409
- Conditions
- Substance Related Disorder, Nicotine Dependence
- Keywords
- Nasal Spray, Attention Network Test, Continuous Performance Test, Attentional Blink Test
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 14 Feb 2006
- Primary completion
- 3 Nov 2009 (actual)
- Study completion
- 3 Nov 2009 (actual)
- First posted
- 17 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (19 listed)
- <!-- -->
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine | Drug | – |
Primary outcome
Pharmacodynamics, changes in cognitive function
1 secondary outcome
Changes in subjective mood, changes in cardiovascular measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 11044746Bancroft 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.
- Background: PubMed 8453850Benowitz 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.
- Background: PubMed 15187577Bizarro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nicotine in people with Substance Related Disorder and Nicotine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamics, changes in cognitive function. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01034020, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.