Nicotine DependenceNCT01037153
Effects of Nicotine on Brain Activity as Measured by fMRI
An observational study of Nicotine Dependence and Drug Abuse, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: Nicotine addiction is common among people who smoke tobacco, and the addictive properties of nicotine make smoking cessation difficult even for people who want to quit. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Drug Abuse
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2002to 25 Jul 2011
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be between the ages of 18 - 50 and in good health, based on history and physical exam, and must demonstrate that they are experienced nicotine users based upon urine nicotine/cotinine levels or exhaled CO.
- Subjects must smoke a minimum of 20 cigarettes/day for at least 1 year.
- Subjects may be users of alcohol and/or marijuana but may not meet criteria for dependence on either and must have a negative urine drug triage prior to scanning.
Who cannot join
- Subjects will be excluded if:
- they are unable to undergo MRI scanning due to pregnancy, implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobia.
- they have any major medical illnesses to include, but not limited to, hypertension, cardiovascular disease, asthma, diabetes, peripheral vascular diseases, coagulopathies, history of superficial or deep vein thrombosis, HIV, or other infectious diseases that may affect the CNS (e.g. syphilis).
- they have any current major psychiatric disorders to include, but not limited to, mood, anxiety, psychotic disorders, or substance-induced psychiatric disorders.
- they have history of neurological illnesses such as seizure disorders, migraine, multiple sclerosis, movement disorders, or history of head trauma, CVA, or CNS tumor.
- they have alcohol or other drug dependence, other than nicotine dependence,
Show all 10Show fewer
- their T1 weighted brain MRI reveals gross structural abnormalities,
- they have a history of syncope.
- they are pregnant
- they are actively seeking or engaged in smoking cessation treatment.
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:
- Nicotine addiction is common among people who smoke tobacco, and the addictive properties of nicotine make smoking cessation difficult even for people who want to quit. Research has shown that smoking causes changes in the brain that lead to addiction and craving, but more research is needed to determine how different doses of nicotine and different intervals of receiving nicotine affect brain function. A greater understanding of nicotine's effect on the brain, as studied through functional magnetic resonance imaging (fMRI), may improve the effectiveness of smoking cessation therapies and treatments.
Read more
Objectives:
- To determine the effects of nicotine on brain function and chemistry in experienced cigarette smokers.
Eligibility:
- Current smokers (at least 20 cigarettes per day for at least 1 year) between 18 and 50 years of age.
Design:
- The study involves five separate research experiments. Most participants will be involved in only one experiment.
- The experiments will evaluate brain activity and function using fMRI. Participants will be trained in a series of tests on cognitive function before beginning the experimental part of the study.
- Experiment 1: Participants will have three fMRI scan sessions after receiving different dose levels of intravenous nicotine.
- Experiment 2: Participants will have four fMRI scan sessions after receiving two doses of nicotine separated by 1/4, 1/2, 3, and 24 hours.
- Experiment 3: Participants will have two sets of nicotine injections separated by 45 minutes, with each injection series containing five rapid injections of small amounts of nicotine (to mimic five puffs on a cigarette).
- Experiment 4: Participants will have three fMRI sessions after receiving a single injection of nicotine at three different rates (over 15, 60, or 120 seconds). In addition there will be three more sessions involving a nicotine patch and a nicotine injection as well as a placebo session.
- Experiment 5: Participants will have three fMRI sessions that will involve looking at different kinds of pictures related to or not related to smoking after receiving a single injection of nicotine.
- Participants will also provide blood samples for further study....
Read the detailed description
Objective:
The overall goal of this protocol is to employ fMRI to define nicotine's neural pharmacokinetic and pharmacodynamic properties and neurochemical sites and mechanisms of action in experienced smokers and to correlate these with monoamine and nicotinic receptor genotypes as well as to determine behavioral correlates of nicotine during various conditions of delivery and regress behavioral correlates of nicotine administration against neuroanatomical sites of activation across subjects.
Study Population:
The study population will consist of adult (18-50 y.o.) non-treatment seeking smokers. Subjects must smoke at least 20 cigarettes per day for at least 1 year. They cannot be dependent on any drug or alcohol except nicotine and caffeine. In addition, they must be appropriate candidates for fMRI scanning.
Design:
The study is divided into 5 separate arms with a maximum of two arms being conducted at one time. The experimental arms explore the effect of intravenous nicotine delivery with respect to the following parameters: dosage, interval of delivery, rate of delivery and emotional processing. Specifically the arms are as follows: Experiment 1: 3 fMRI scan sessions each administering either 0.25, 0.75 and 1.5 mg IV nicotine; Experiment 2: 4 fMRI scan sessions administering two doses of 1.25 mg nicotine separated by 0.25, 0.75, 3 and 24 hours; Experiment 3: two injection series separated by 45 minutes, each injection series containing 5 rapid injections of 0.25 mg each, much like 5 puffs on a cigarette; Experiment 4: 3 fMRI sessions administering a single injection of 1.5 mg nicotine at 3 different rates- over 15, 60 or 120 seconds; and Experiment 5: 3 fMRI session administering 1.5 mg nicotine followed by exposure to either neutral, negative, or positive affect pictures. Since experimental arms are conducted in series, rather than in parallel, there are very few subjects common to more than one experimental arm.
Outcome Measures:
The relevant outcome measures in this study are the behavioral and physiological effects and the patterns of brain regions activated (or suppressed) following the intravenous administration of nicotine across varying doses, intervals, rates and the effect on these parameters of emotional processing in the context of nicotine of stimuli with different affective valence.
- Conditions
- Nicotine Dependence, Drug Abuse
- Keywords
- Intravenous, Rate of Delivery, Dose Responses, Variable Intervals, Multiple Rapid Injections
- Medical subject headings
- Tobacco Use Disorder, Substance-Related Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study start6 Aug 2002
- Study completion25 Jul 2011
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 Nicotine DependenceStudies 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
- Observational
- Enrolment
- 128 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
- NCT01037153
- Sponsor's protocol ID
- 999902371
- Other IDs
- 02-DA-N371
- Status last verified
- 25 Jul 2011
- First submitted
- 18 Dec 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Aceto MD, Martin BR. Central actions of nicotine. Med Res Rev. 1982 Jan-Mar;2(1):43-62. doi: 10.1002/med.2610020104. No abstract available.
PubMed 6125634Avants SK, Margolin A, Kosten TR, Cooney NL. Differences between responders and nonresponders to cocaine cues in the laboratory. Addict Behav. 1995 Mar-Apr;20(2):215-24. doi: 10.1016/0306-4603(94)00066-2.
PubMed 7484315Bandettini PA, Jesmanowicz A, Wong EC, Hyde JS. Processing strategies for time-course data sets in functional MRI of the human brain. Magn Reson Med. 1993 Aug;30(2):161-73. doi: 10.1002/mrm.1910300204.
PubMed 8366797
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 Brain Activity as Measured by fMRI
- ClinicalTrials.gov ID
- NCT01037153
- Acronym / sponsor ID
- 999902371
- Conditions
- Nicotine Dependence, Drug Abuse
- Keywords
- Intravenous, Rate of Delivery, Dose Responses, Variable Intervals, Multiple Rapid Injections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 6 Aug 2002
- Study completion
- 25 Jul 2011
- First posted
- 21 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:
- Nicotine addiction is common among people who smoke tobacco, and the addictive properties of nicotine make smoking cessation difficult even for people who want to quit. Research has shown that smoking causes changes in the brain that lead to addiction and craving, but more research is needed to determine how different doses of nicotine and different intervals of receiving nicotine affect brain function. A greater understanding of nicotine's effect on the brain, as studied through functional magnetic resonance imaging (fMRI), may improve the effectiveness of smoking cessation therapies and treatments.
Objectives:
- To determine the effects of nicotine on brain function and chemistry in experienced cigarette smokers.
Eligibility:
- Current smokers (at least 20 cigarettes per day for at least 1 year) between 18 and 50 years of age.
Design:
- The study involves five separate research experiments. Most participants will be involved in only one experiment.
- The experiments will evaluate brain activity and function using fMRI. Participants will be trained in a series of tests on cognitive function before beginning the experimental part of the study.
- Experiment 1: Participants will have three fMRI scan sessions after receiving different dose levels of intravenous nicotine.
- Experiment 2: Participants will have four fMRI scan sessions after receiving two doses of nicotine separated by 1/4, 1/2, 3, and 24 hours.
- Experiment 3: Participants will have two sets of nicotine injections separated by 45 minutes, with each injection series containing five rapid injections of small amounts of nicotine (to mimic five puffs on a cigarette).
- Experiment 4: Participants will have three fMRI sessions after receiving a single injection of nicotine at three different rates (over 15, 60, or 120 seconds). In addition there will be three more sessions involving a nicotine patch and a nicotine injection as well as a placebo session.
- Experiment 5: Participants will have three fMRI sessions that will involve looking at different kinds of pictures related to or not related to smoking after receiving a single injection of nicotine.
- Participants will also provide blood samples for further study....
Detailed description
Objective:
The overall goal of this protocol is to employ fMRI to define nicotine's neural pharmacokinetic and pharmacodynamic properties and neurochemical sites and mechanisms of action in experienced smokers and to correlate these with monoamine and nicotinic receptor genotypes as well as to determine behavioral correlates of nicotine during various conditions of delivery and regress behavioral correlates of nicotine administration against neuroanatomical sites of activation across subjects.
Study Population:
The study population will consist of adult (18-50 y.o.) non-treatment seeking smokers. Subjects must smoke at least 20 cigarettes per day for at least 1 year. They cannot be dependent on any drug or alcohol except nicotine and caffeine. In addition, they must be appropriate candidates for fMRI scanning.
Design:
The study is divided into 5 separate arms with a maximum of two arms being conducted at one time. The experimental arms explore the effect of intravenous nicotine delivery with respect to the following parameters: dosage, interval of delivery, rate of delivery and emotional processing. Specifically the arms are as follows: Experiment 1: 3 fMRI scan sessions each administering either 0.25, 0.75 and 1.5 mg IV nicotine; Experiment 2: 4 fMRI scan sessions administering two doses of 1.25 mg nicotine separated by 0.25, 0.75, 3 and 24 hours; Experiment 3: two injection series separated by 45 minutes, each injection series containing 5 rapid injections of 0.25 mg each, much like 5 puffs on a cigarette; Experiment 4: 3 fMRI sessions administering a single injection of 1.5 mg nicotine at 3 different rates- over 15, 60 or 120 seconds; and Experiment 5: 3 fMRI session administering 1.5 mg nicotine followed by exposure to either neutral, negative, or positive affect pictures. Since experimental arms are conducted in series, rather than in parallel, there are very few subjects common to more than one experimental arm.
Outcome Measures:
The relevant outcome measures in this study are the behavioral and physiological effects and the patterns of brain regions activated (or suppressed) following the intravenous administration of nicotine across varying doses, intervals, rates and the effect on these parameters of emotional processing in the context of nicotine of stimuli with different affective valence.
Study design
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
Key exclusion criteria (10 listed)
- they are unable to undergo MRI scanning due to pregnancy, implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobia.
- they have any major medical illnesses to include, but not limited to, hypertension, cardiovascular disease, asthma, diabetes, peripheral vascular diseases, coagulopathies, history of superficial or deep vein thrombosis, HIV, or other infectious diseases that may affect the CNS (e.g. syphilis).
- they have any current major psychiatric disorders to include, but not limited to, mood, anxiety, psychotic disorders, or substance-induced psychiatric disorders.
- they have history of neurological illnesses such as seizure disorders, migraine, multiple sclerosis, movement disorders, or history of head trauma, CVA, or CNS tumor.
- they have alcohol or other drug dependence, other than nicotine dependence,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 6125634Aceto MD, Martin BR. Central actions of nicotine. Med Res Rev. 1982 Jan-Mar;2(1):43-62. doi: 10.1002/med.2610020104. No abstract available.
- Background: PubMed 7484315Avants SK, Margolin A, Kosten TR, Cooney NL. Differences between responders and nonresponders to cocaine cues in the laboratory. Addict Behav. 1995 Mar-Apr;20(2):215-24. doi: 10.1016/0306-4603(94)00066-2.
- Background: PubMed 8366797Bandettini PA, Jesmanowicz A, Wong EC, Hyde JS. Processing strategies for time-course data sets in functional MRI of the human brain. Magn Reson Med. 1993 Aug;30(2):161-73. doi: 10.1002/mrm.1910300204.
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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?
An observational study of Nicotine Dependence and Drug Abuse, 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 3 inclusion and 10 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01037153, 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.