Drug AddictionPhase 1NCT01136642
Assessing Top Down and Bottom Up Attention Mechanisms in Smokers Using Nicotine Nasal Spray
A Phase 1 study testing Nicotrol in people with Drug Addiction and Nicotine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: Smoking is the leading cause of preventable death in the United States, and researchers are interested in gaining a better understanding of the perceived beneficial effects of nicotine to help improve treatment strategies for nicotine dependence. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Addiction, Nicotine Dependence
- What is being tested?
- Nicotrol
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2010to 13 Nov 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-55 year old male and female cigarette smokers
- smoke a minimum of 10 cigarettes per day for at least 1 year
- --Drug Use Survey
- estimated IQ score greater than or equal to 85
- --Weschsler Abbreviated Scale of Intelligence (WASI; raw vocabulary cutoff 49)
- urine cotinine concentration greater than or equal 100 ng/ml
- NicAlert reading greater than or equal to 3
Who cannot join
- definite plan to quit smoking in next 30 days
- consumption of more than 15 alcoholic drinks per week during the past month
- use of any illicit drugs more than twice per week during the past month
- --Drug Use Survey (items 2-4)
- pregnant or nursing
- --Urine pregnancy test
Show all 22Show fewer
- HIV positive
- --Oral HIV test
- untreated cardiovascular or pulmonary disease
- use of nicotine replacement products, bupropion or varenicline, in the past 3 months if specifically used to stop smoking
- Past history of schizophrenia or bipolar disorder.
- Current Major Depression Disorder, Diagnosis or treatment for Major Depressive Disorder in past 12 months. (H\&P)
- Evidence of current ADHD by current diagnosis or medication or score on Adult Symptom Rating Scale; (> 16 on pt A or B must be evaluated by a counselor)
- SCL-90 > 65 (must be evaluated by a counselor)
- Beck Depression Inventory-II score greater than or equal to 14 (must be evaluated by a counselor)
- vital signs (must be outside these parameters on more than two occasions separated by at least one day):
- systolic blood pressure: minimum 95, maximum 160 mm Hg
- diastolic blood pressure: minimum 40, maximum 95 mm Hg
- pulse: minimum 50, maximum 105 bpm
- respirations: minimum 8, maximum 24 breaths per minute
- nasal passages: no pathology that would preclude administration of nasal spray
- under the influence of a drug or alcohol at experimental sessions
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:
- Smoking is the leading cause of preventable death in the United States, and researchers are interested in gaining a better understanding of the perceived beneficial effects of nicotine to help improve treatment strategies for nicotine dependence. Understanding the conditions under which nicotine improves attention and cognitive processing may provide more useful information for this research.
- The ability to pay attention and filter relevant from irrelevant stimuli is central to all aspects of information-processing. Top-down and bottom-up attentional processes illustrate how the brain combines stimuli and goal-directed behaviors. Bottom-up processing is an unconscious response to sensory input; for instance, when the eyes automatically focus on a prominent image in a picture. Top-down processing is a conscious response to drive attention toward specific stimuli; for instance, when a person is asked to focus on a less immediately noticeable image in a picture. Researchers are interested in determining whether nicotine improves cognitive performance by acting on top-down or bottom-up attentional mechanisms.
Read more
Objectives:
- To investigate the effect of nicotine on the top-down and bottom-up mechanisms of attention in cigarette smokers.
Eligibility:
- Current smokers (at least 10 cigarettes per day for at least 1 year) between 18 and 55 years of age.
Design:
- This study will involve one training session and four experimental sessions.
- During the training session, participants will receive a sample dose of the nicotine nasal spray used in the study to determine if they can tolerate the effects.
- For each experimental session, participants will receive one dose of nicotine nasal spray (1 mg, 2 mg, or 3 mg) or placebo spray, followed by blood pressure and heart rate monitoring, performance of an attentional test, and questionnaires to rate participants perception of nicotine effectiveness. Participants may receive different doses at different sessions, and will not be told which dose they will receive at any given point.
Read the detailed description
Objective:
The objective is to investigate the dose-response effect of nicotine on the top-down and bottom-up mechanisms of attention in cigarette smokers.
Study population:
Male and nonpregnant-female smokers 18 to 55 years of age.
Design:
This study is a double-blind, placebo controlled trial of nicotine or placebo nasal sprays. Participants have five visits: a training session and four experimental sessions. Each participant receives a test dose of the nasal spray immediately following the training session to ascertain tolerability and become familiarized with the effect of the spray. One dose (0, 1.0, 2.0 or 3.0 mg) of nicotine nasal spray is administered at the beginning of each experimental session followed by the test battery.
Outcome Measures:
Outcome measures are vital signs, ratings of mood and drug effect, and performance (accuracy, response time) on a test of selective attention.
- Conditions
- Drug Addiction, Nicotine Dependence
- Being tested
- Nicotrol
- Keywords
- Nicotine, Nicotine Nasal Spray, Attention, Smoking
- Medical subject headings
- Substance-Related Disorders, Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotrolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance (accuracy response time) on a test of selective attention.
Secondary outcomes (1)
Vital signs, ratings of mood and drug effect.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study start21 Jan 2010
- Study completion13 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AddictionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Carol Myers, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136642
- Sponsor's protocol ID
- 999910459
- Other IDs
- 10-DA-N459
- Status last verified
- 13 Nov 2012
- First submitted
- 2 Jun 2010
- Last updated
- 16 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Top Down and Bottom Up Attention Mechanisms in Smokers Using Nicotine Nasal Spray
- ClinicalTrials.gov ID
- NCT01136642
- Acronym / sponsor ID
- 999910459
- Conditions
- Drug Addiction, Nicotine Dependence
- Keywords
- Nicotine, Nicotine Nasal Spray, Attention, Smoking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 21 Jan 2010
- Study completion
- 13 Nov 2012 (actual)
- First posted
- 3 Jun 2010 (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:
- Smoking is the leading cause of preventable death in the United States, and researchers are interested in gaining a better understanding of the perceived beneficial effects of nicotine to help improve treatment strategies for nicotine dependence. Understanding the conditions under which nicotine improves attention and cognitive processing may provide more useful information for this research.
- The ability to pay attention and filter relevant from irrelevant stimuli is central to all aspects of information-processing. Top-down and bottom-up attentional processes illustrate how the brain combines stimuli and goal-directed behaviors. Bottom-up processing is an unconscious response to sensory input; for instance, when the eyes automatically focus on a prominent image in a picture. Top-down processing is a conscious response to drive attention toward specific stimuli; for instance, when a person is asked to focus on a less immediately noticeable image in a picture. Researchers are interested in determining whether nicotine improves cognitive performance by acting on top-down or bottom-up attentional mechanisms.
Objectives:
- To investigate the effect of nicotine on the top-down and bottom-up mechanisms of attention in cigarette smokers.
Eligibility:
- Current smokers (at least 10 cigarettes per day for at least 1 year) between 18 and 55 years of age.
Design:
- This study will involve one training session and four experimental sessions.
- During the training session, participants will receive a sample dose of the nicotine nasal spray used in the study to determine if they can tolerate the effects.
- For each experimental session, participants will receive one dose of nicotine nasal spray (1 mg, 2 mg, or 3 mg) or placebo spray, followed by blood pressure and heart rate monitoring, performance of an attentional test, and questionnaires to rate participants perception of nicotine effectiveness. Participants may receive different doses at different sessions, and will not be told which dose they will receive at any given point.
Detailed description
Objective:
The objective is to investigate the dose-response effect of nicotine on the top-down and bottom-up mechanisms of attention in cigarette smokers.
Study population:
Male and nonpregnant-female smokers 18 to 55 years of age.
Design:
This study is a double-blind, placebo controlled trial of nicotine or placebo nasal sprays. Participants have five visits: a training session and four experimental sessions. Each participant receives a test dose of the nasal spray immediately following the training session to ascertain tolerability and become familiarized with the effect of the spray. One dose (0, 1.0, 2.0 or 3.0 mg) of nicotine nasal spray is administered at the beginning of each experimental session followed by the test battery.
Outcome Measures:
Outcome measures are vital signs, ratings of mood and drug effect, and performance (accuracy, response time) on a test of selective attention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- --Drug Use Survey
- --Weschsler Abbreviated Scale of Intelligence (WASI; raw vocabulary cutoff 49)
Key exclusion criteria (22 listed)
- definite plan to quit smoking in next 30 days
- consumption of more than 15 alcoholic drinks per week during the past month
- use of any illicit drugs more than twice per week during the past month
- --Drug Use Survey (items 2-4)
- pregnant or nursing
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 |
|---|---|---|
| Nicotrol | Drug | – |
Primary outcome
Performance (accuracy response time) on a test of selective attention.
1 secondary outcome
Vital signs, ratings of mood and drug effect.
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 16 Dec 2019.
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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.
Carol Myers, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
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 Nicotrol in people with Drug Addiction 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 7 inclusion and 22 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 16 Dec 2019. 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?
Performance (accuracy response time) on a test of selective attention.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2019.