Nicotine DependenceNCT01048957
The Neural Basis of Cue-Elicited Cigarette Craving and Its Control
A study testing Real Time Feedback Training in people with Nicotine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: One kind of drug craving, known as cue-elicited craving, occurs when a drug user who sees a drug-related cue (such as an image of someone using the drug) begins to feel a craving for the drug. 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
- What is being tested?
- Real Time Feedback Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2007to 8 Apr 2013
- Phase
- Interventional
- 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
- All participants must:
- Be between the ages of 18-50. Justification: Many cognitive processes change with age. In addition, the risk of difficult-to-detect medical abnormalities such as silent cerebral infarcts increases with age. Therefore, older individuals, defined as those over 50, will be excluded.
- Be in good health. Justification: Many illnesses can alter fMRI signal, and cognition. Assessment tool(s): Participants will provide a brief health history during phone screening, and undergo a history and physical examination with a qualified IRP clinician.
- Be right-handed. Justification: Many of the brain functions to be assessed in this protocol have shown some evidence of being lateralized in the brain. In order to reduce the variance in the data from this possibility, participants must be right-handed. Assessment tool(s): Edinburgh Handedness Inventory
- Be free of dependence on other substances (except nicotine). Justification: Dependence on other substances may result in unique CNS deficits that would increase the noise in our data. Assessment tool(s): Substance Use Disorders module of the SCID with confirmation by clinical interview and negative urine drug screen.
- Must smoke greater than or equal to 10 cigarettes per day for at least two years, with urine cotinine levels of at least 100ng/ml and score on the Fagerstrom Test for Nicotine Dependence (FTND) must be greater than or equal to 2. Justification: The aim is to study phenomena that are linked to nicotine dependence and that occur with regular and frequent smoking. Assessment tool(s): Self-report, a urine cotinine test (smokers will be defined as having cotinine levels greater than or equal to 100ng/mL), and FTND test.
- All participants should be able to abstain from alcohol for 24 hours and no more than 1/2 cup of caffeine for 12 hours before each experiment session. Justification: Alcohol and caffeine may result in brain that influences our data. Assessment tool(s): Self-report and breathalyzer test.
Who cannot join
- Participants will be excluded if they:
- Are not suitable to undergo an fMRI experiment due to pregnancy, implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts), body morphology or claustrophobia. Justification: MR scanning is one of the primary measurement tools used in the protocol. Assessment tool(s): Prospective participants will fill out an MRI screening questionnaire and undergo an interview with an MR technologist. Pregnancy tests will be performed on all female participants of childbearing age before each experimental session. Questions concerning suitability for scanning will be referred to the MR Medical Safety Officer. Prospective participants will be questioned about symptoms of claustrophobia and placed in the mock scanner during their first visit to assess for possible difficulty tolerating the confinement of the scanner and for ability to fit into the scanner.
- Have coagulopathies, history of, current superficial, or deep vein thrombosis, musculoskeletal abnormalities restricting an individual s ability to lie flat for extended periods of time. Justification: MR scanning sessions require participants to lie flat on their backs and remain perfectly still for approximately two hours. Therefore, conditions that would make that difficult (e.g. chronic back pain, significant scoliosis) or dangerous (e.g. familial hypercoagulability syndrome, history of thrombosis) will be exclusionary. Assessment tool(s): History and physical examination by a qualified IRP clinician, supplemented with a trial of lying in the mock scanner to assess comfort issues.
- Have HIV or Syphilis. Justification: HIV and Syphilis can both have CNS sequelae, thus introducing unnecessary variability into the data. Assessment tool(s): HIV blood test and RPR+.
- Have any neurological illnesses to include, but not limited to, seizure disorders, migraine (>2/yr or on prophylaxis), multiple sclerosis, movement disorders, or history of significant head trauma, CVA, CNS tumor. Justification: CNS diseases alter CNS function and, possibly, the neuronal-vascular coupling that forms the basis of the BOLD fMRI signal to be used in this study. Assessment tool(s): History and physical examination by a qualified IRP clinician, urine drug screening for anticonvulsants not disclosed by history. History of head trauma with loss of consciousness of more than 5 minutes or with post-concussive sequelae lasting more than two days, regardless of loss of consciousness, will be exclusionary.
- Have other major medical illnesses likely to interfere with study results or safety of an individual during participation. Justification: Many illness not covered here may increase risk or alter important outcome measures. Assessment tool(s): History and physical examination by a qualified IRP clinician and CBC, urinalysis, NIDA chemistry panel (liver function tests, electrolytes, kidney function). The following individual laboratory results will independently disqualify individuals. The MRP will retain discretion to exclude at less extreme values, depending on the clinical presentation, and will make the final judgment on any questionable lab results
Show all 17Show fewer
- Hemoglobin < 10 g/dl
- WBC < 2400/microl
- LFTs > 3 times normal
- HCG positive
- Serum glucose > 200 mg/dl
- Urine protein > 2 plus
- Serum cholesterol level> 250 mg/dl.
- Have any current major psychiatric disorders to include, but not limited to, mood, anxiety, psychotic disorders, or substance-induced psychiatric disorders. Justification: Psychiatric disorders involve the central neural system (CNS) and, therefore, can be expected to alter the fMRI measures being used in this study. Assessment tool(s): Computerized SCID-NP, ASRS (adult ADHD self-report scale) and DSM-IV (DSM-IV, APA, 1994) confirmed by clinician interview.
- Regularly use any prescription, over-the-counter or herbal medication that may alter CNS function, cardiovascular function or neuronal-vascular coupling. Justification: Compounds that alter BOLD signal will alter the primary measure used in the study. Assessment tool(s): History and comprehensive urine drug screening to detect antidepressants, benzodiazepines, antipsychotics, anticonvulsants, barbiturates and other common medications and drugs of abuse.
- Are cognitively impaired or learning disabled. Justification: Cognitive impairment and learning disabilities are associated with alterations in brain regions used to accomplish tasks, and, therefore, may introduce significant variably into the data. In addition, cognitive impairment may affect ability to give informed consent. Assessment tool(s): History of known learning disability or cognitive impairment. Vocabulary subtest of the WASI will be given. IQ estimate must be over 85 (corresponding to a vocabulary subtest score > 48). In cases of suspected non-verbal learning disability or mild verbal deficit, a full WASI may be given to obtain a more robust estimate of IQ.
- Significant cardiovascular or cerebrovascular diseases. Justification: Such conditions can alter and distort BOLD and autonomic signals and increase the risks associated with nicotine patch use. Assessment tool(s): History and physical exam, including 12-lead ECG.
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:
- One kind of drug craving, known as cue-elicited craving, occurs when a drug user who sees a drug-related cue (such as an image of someone using the drug) begins to feel a craving for the drug. Researchers are interested in studying how cue-elicited craving affects brain activity using functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) data.
Read more
Objectives:
- To determine which parts of the brain are associated with or involved in controlling cue-related craving in smokers.
Eligibility:
- Individuals between 18 and 50 years of age who are current smokers (10 or more cigarettes per day) and agree to try to abstain from smoking for 1 week during the experiment.
Design:
- Participants will visit a clinical center for up to four scanning sessions, and will be asked to perform two or three outpatient tasks at home over the course of the study.
- Scan 1: Training session with a mock fMRI scanner, followed by an actual fMRI scanning session and EEG in which participants respond to pictures.
- Outpatient Task 1: Tolerance test with nicotine patch (worn for 8 hours, followed by 12 additional hours without cigarette use).
- Scans 2 and 3: Training session and fMRI scan and testing with either nicotine patch or placebo. Tasks in fMRI involve looking at cues, reporting craving and suppressing craving.
- Outpatient Task 2: Participants will keep an electronic diary for 10 to 14 days, responding to questions as directed by the researchers.
- Scans 4 and 5: Training session, fMRI scan and EEG, and testing in which participants will be instructed on methods to attempt to control cravings.
- Outpatient Task 3: Participants will keep an electronic diary for 14 days. For the first 7 days, participants will be asked to attempt to abstain from nicotine; participants may smoke normally on the second 7 days.
- Participants will be contacted 1, 3, 6, and 12 months after the end of the study for follow-up questions on current smoking habits.
Read the detailed description
Objective: Drug craving is a motivational state associated with a conscious desire to consume a drug (Fredrickson et al., 1995; Drummond, 2001). When drug abusers see drug-related cues, cue-elicited drug craving is induced (Drummond, 2001). The main goal of this investigation is to ascertain the neural basis of cue-elicited drug (e.g. cigarette) craving and its control in smokers.
Study population: The experimental population for this investigation is nicotine-dependent adults aged 18-50 years old.
Design: Participants will see the smoking-related cue or neutral cue and complete cognitive tasks (e.g. to report or regulate their craving, etc). At same time, we will employ functional magnetic resonance imaging (fMRI), real-time functional magnetic resonance imaging (rtfMRI), and electroencephalography (EEG) to measure brain activity.
Outcome measures: There is no direct benefit to the participant by joining this study. Data from this study are expected to contribute to a better understanding of the neural processes of cigarette craving. Thus, the results may benefit the health of society. MRI-related risks (e.g., injury from metal implants, claustrophobia, and temporary hearing threshold alterations due to the loud banging noises) and nicotine-patch-related risks (e.g., dizziness, headache, upset stomach, vomiting, diarrhea, redness or swelling at the patch site) to participants are minimized by careful prescreening and standard protection.
- Conditions
- Nicotine Dependence
- Being tested
- Real Time Feedback Training
- Keywords
- Nicotine, Craving, fMRI, EEG, Real Time fMRI Feedback
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Time Feedback TrainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
To ascertain the neural basis of cue-elicited drug (e.g. cigarette) craving and its control in smokers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study start9 Jan 2007
- Primary completion8 Apr 2013
- Study completion8 Apr 2013
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Elliot Stein, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048957
- Sponsor's protocol ID
- 999907418
- Other IDs
- 07-DA-N418
- Status last verified
- 8 Apr 2013
- First submitted
- 13 Jan 2010
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Andreasen NC, Endicott J, Spitzer RL, Winokur G. The family history method using diagnostic criteria. Reliability and validity. Arch Gen Psychiatry. 1977 Oct;34(10):1229-35. doi: 10.1001/archpsyc.1977.01770220111013.
PubMed 911222Aron AR, Fletcher PC, Bullmore ET, Sahakian BJ, Robbins TW. Stop-signal inhibition disrupted by damage to right inferior frontal gyrus in humans. Nat Neurosci. 2003 Feb;6(2):115-6. doi: 10.1038/nn1003. No abstract available.
PubMed 12536210Babiloni F, Mattia D, Babiloni C, Astolfi L, Salinari S, Basilisco A, Rossini PM, Marciani MG, Cincotti F. Multimodal integration of EEG, MEG and fMRI data for the solution of the neuroimage puzzle. Magn Reson Imaging. 2004 Dec;22(10):1471-6. doi: 10.1016/j.mri.2004.10.007.
PubMed 15707796
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
- The Neural Basis of Cue-Elicited Cigarette Craving and Its Control
- ClinicalTrials.gov ID
- NCT01048957
- Acronym / sponsor ID
- 999907418
- Conditions
- Nicotine Dependence
- Keywords
- Nicotine, Craving, fMRI, EEG, Real Time fMRI Feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 9 Jan 2007
- Primary completion
- 8 Apr 2013 (actual)
- Study completion
- 8 Apr 2013 (actual)
- First posted
- 14 Jan 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:
- One kind of drug craving, known as cue-elicited craving, occurs when a drug user who sees a drug-related cue (such as an image of someone using the drug) begins to feel a craving for the drug. Researchers are interested in studying how cue-elicited craving affects brain activity using functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) data.
Objectives:
- To determine which parts of the brain are associated with or involved in controlling cue-related craving in smokers.
Eligibility:
- Individuals between 18 and 50 years of age who are current smokers (10 or more cigarettes per day) and agree to try to abstain from smoking for 1 week during the experiment.
Design:
- Participants will visit a clinical center for up to four scanning sessions, and will be asked to perform two or three outpatient tasks at home over the course of the study.
- Scan 1: Training session with a mock fMRI scanner, followed by an actual fMRI scanning session and EEG in which participants respond to pictures.
- Outpatient Task 1: Tolerance test with nicotine patch (worn for 8 hours, followed by 12 additional hours without cigarette use).
- Scans 2 and 3: Training session and fMRI scan and testing with either nicotine patch or placebo. Tasks in fMRI involve looking at cues, reporting craving and suppressing craving.
- Outpatient Task 2: Participants will keep an electronic diary for 10 to 14 days, responding to questions as directed by the researchers.
- Scans 4 and 5: Training session, fMRI scan and EEG, and testing in which participants will be instructed on methods to attempt to control cravings.
- Outpatient Task 3: Participants will keep an electronic diary for 14 days. For the first 7 days, participants will be asked to attempt to abstain from nicotine; participants may smoke normally on the second 7 days.
- Participants will be contacted 1, 3, 6, and 12 months after the end of the study for follow-up questions on current smoking habits.
Detailed description
Objective: Drug craving is a motivational state associated with a conscious desire to consume a drug (Fredrickson et al., 1995; Drummond, 2001). When drug abusers see drug-related cues, cue-elicited drug craving is induced (Drummond, 2001). The main goal of this investigation is to ascertain the neural basis of cue-elicited drug (e.g. cigarette) craving and its control in smokers.
Study population: The experimental population for this investigation is nicotine-dependent adults aged 18-50 years old.
Design: Participants will see the smoking-related cue or neutral cue and complete cognitive tasks (e.g. to report or regulate their craving, etc). At same time, we will employ functional magnetic resonance imaging (fMRI), real-time functional magnetic resonance imaging (rtfMRI), and electroencephalography (EEG) to measure brain activity.
Outcome measures: There is no direct benefit to the participant by joining this study. Data from this study are expected to contribute to a better understanding of the neural processes of cigarette craving. Thus, the results may benefit the health of society. MRI-related risks (e.g., injury from metal implants, claustrophobia, and temporary hearing threshold alterations due to the loud banging noises) and nicotine-patch-related risks (e.g., dizziness, headache, upset stomach, vomiting, diarrhea, redness or swelling at the patch site) to participants are minimized by careful prescreening and standard protection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Be between the ages of 18-50. Justification: Many cognitive processes change with age. In addition, the risk of difficult-to-detect medical abnormalities such as silent cerebral infarcts increases with age. Therefore, older individuals, defined as those over 50, will be excluded.
- Be in good health. Justification: Many illnesses can alter fMRI signal, and cognition. Assessment tool(s): Participants will provide a brief health history during phone screening, and undergo a history and physical examination with a qualified IRP clinician.
- Be right-handed. Justification: Many of the brain functions to be assessed in this protocol have shown some evidence of being lateralized in the brain. In order to reduce the variance in the data from this possibility, participants must be right-handed. Assessment tool(s): Edinburgh Handedness Inventory
- Be free of dependence on other substances (except nicotine). Justification: Dependence on other substances may result in unique CNS deficits that would increase the noise in our data. Assessment tool(s): Substance Use Disorders module of the SCID with confirmation by clinical interview and negative urine drug screen.
- Must smoke greater than or equal to 10 cigarettes per day for at least two years, with urine cotinine levels of at least 100ng/ml and score on the Fagerstrom Test for Nicotine Dependence (FTND) must be greater than or equal to 2. Justification: The aim is to study phenomena that are linked to nicotine dependence and that occur with regular and frequent smoking. Assessment tool(s): Self-report, a urine cotinine test (smokers will be defined as having cotinine levels greater than or equal to 100ng/mL), and FTND test.
Key exclusion criteria (17 listed)
- Are not suitable to undergo an fMRI experiment due to pregnancy, implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts), body morphology or claustrophobia. Justification: MR scanning is one of the primary measurement tools used in the protocol. Assessment tool(s): Prospective participants will fill out an MRI screening questionnaire and undergo an interview with an MR technologist. Pregnancy tests will be performed on all female participants of childbearing age before each experimental session. Questions concerning suitability for scanning will be referred to the MR Medical Safety Officer. Prospective participants will be questioned about symptoms of claustrophobia and placed in the mock scanner during their first visit to assess for possible difficulty tolerating the confinement of the scanner and for ability to fit into the scanner.
- Have coagulopathies, history of, current superficial, or deep vein thrombosis, musculoskeletal abnormalities restricting an individual s ability to lie flat for extended periods of time. Justification: MR scanning sessions require participants to lie flat on their backs and remain perfectly still for approximately two hours. Therefore, conditions that would make that difficult (e.g. chronic back pain, significant scoliosis) or dangerous (e.g. familial hypercoagulability syndrome, history of thrombosis) will be exclusionary. Assessment tool(s): History and physical examination by a qualified IRP clinician, supplemented with a trial of lying in the mock scanner to assess comfort issues.
- Have HIV or Syphilis. Justification: HIV and Syphilis can both have CNS sequelae, thus introducing unnecessary variability into the data. Assessment tool(s): HIV blood test and RPR+.
- Have any neurological illnesses to include, but not limited to, seizure disorders, migraine (>2/yr or on prophylaxis), multiple sclerosis, movement disorders, or history of significant head trauma, CVA, CNS tumor. Justification: CNS diseases alter CNS function and, possibly, the neuronal-vascular coupling that forms the basis of the BOLD fMRI signal to be used in this study. Assessment tool(s): History and physical examination by a qualified IRP clinician, urine drug screening for anticonvulsants not disclosed by history. History of head trauma with loss of consciousness of more than 5 minutes or with post-concussive sequelae lasting more than two days, regardless of loss of consciousness, will be exclusionary.
- Have other major medical illnesses likely to interfere with study results or safety of an individual during participation. Justification: Many illness not covered here may increase risk or alter important outcome measures. Assessment tool(s): History and physical examination by a qualified IRP clinician and CBC, urinalysis, NIDA chemistry panel (liver function tests, electrolytes, kidney function). The following individual laboratory results will independently disqualify individuals. The MRP will retain discretion to exclude at less extreme values, depending on the clinical presentation, and will make the final judgment on any questionable lab results
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 |
|---|---|---|
| Real Time Feedback Training | Behavioural | – |
Primary outcome
To ascertain the neural basis of cue-elicited drug (e.g. cigarette) craving and its control in smokers.
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.
- Background: PubMed 911222Andreasen NC, Endicott J, Spitzer RL, Winokur G. The family history method using diagnostic criteria. Reliability and validity. Arch Gen Psychiatry. 1977 Oct;34(10):1229-35. doi: 10.1001/archpsyc.1977.01770220111013.
- Background: PubMed 12536210Aron AR, Fletcher PC, Bullmore ET, Sahakian BJ, Robbins TW. Stop-signal inhibition disrupted by damage to right inferior frontal gyrus in humans. Nat Neurosci. 2003 Feb;6(2):115-6. doi: 10.1038/nn1003. No abstract available.
- Background: PubMed 15707796Babiloni F, Mattia D, Babiloni C, Astolfi L, Salinari S, Basilisco A, Rossini PM, Marciani MG, Cincotti F. Multimodal integration of EEG, MEG and fMRI data for the solution of the neuroimage puzzle. Magn Reson Imaging. 2004 Dec;22(10):1471-6. doi: 10.1016/j.mri.2004.10.007.
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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.
Elliot Stein, 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 study testing Real Time Feedback Training in people with 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 17 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.
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?
To ascertain the neural basis of cue-elicited drug (e.g. cigarette) craving and its control in smokers.. 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 NCT01048957, 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 16 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.