Nicotine DependencePhase 1NCT01031693
Pilot Study of Transcranial Magnetic Stimulation (TMS) in Nicotine Addiction
A Phase 1 study testing Transcranial Magnetic Stimulation in people with Nicotine Dependence, run by National Institute on Drug Abuse (NIDA) at 2 sites in United States.
Trial summary
Background: Treatment for nicotine addiction is characterized by high rates of relapse. New treatment therapies for nicotine addiction are exploring the use of brain scanning equipment to control and decrease nicotine and cigarette cravings. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jul 2009to 28 Aug 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Personal or first-degree family history of any clinically defined neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness.
- Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head that cannot be safely removed.
- Metal shrapnel or bullet in the head or body including metal shavings.
- Current use of any investigational drug or of any medications with anti or pro-convulsive action
- Increased intracranial pressure (lowers seizure threshold)
- Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania
Show all 10Show fewer
- History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or any heart condition currently under medical care.
- Pregnant or nursing women or women with reproductive potential who are sexually active and not using an acceptable form of contraception.
- Any history of seizure
- Current dependence (DSM-IV criteria) on substances other than nicotine.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institute on Drug Abuse
Baltimore, Maryland, 21224
Maryland Psychiatric Research Center (MPRC) 55 Wade Avenue
Catonsville, Maryland, 21228
About this study
Background:
- Treatment for nicotine addiction is characterized by high rates of relapse. New treatment therapies for nicotine addiction are exploring the use of brain scanning equipment to control and decrease nicotine and cigarette cravings.
- Transcranial magnetic stimulation (TMS) uses magnetic pulses to stimulate the brain. These pulses can change activity in parts of the brain. Researchers are interested in determining whether TMS delivered in single pulses can decrease activity in the parts of the brain that respond to nicotine craving.
Read more
Objectives:
- To determine whether single pulse TMS can reduce cue-induced nicotine craving and use in cigarette smokers.
Eligibility:
- Individuals 18 years of age and older who are physically healthy and have smoked 10 or more cigarettes per day for at least 1 year.
- A small group of healthy nonsmoking control subjects 18 years of age and older will also participate in the study.
Design:
- The study will involve seven study visits and two follow-up visits. The control participants will have only two visits: one with a magnetic resonance imaging (MRI) scan and one with TMS to evaluate brain function and response.
- Participants will have an initial assessment about tobacco use habits and craving patterns, and will provide blood and urine samples before beginning the study.
- Participants will have two initial MRI brain scans. The first scan will look at the structure of the brain at rest. During the other scan, participants will look at images related to and not related to cigarette smoking.
- The single pulse TMS sessions (with either actual TMS or inactive [sham] TMS) will be held daily for 5 consecutive days. Magnetic pulses will be triggered by cigarette-related picture cues and delivered at varying intervals before the participant sees a cigarette-related picture. During these testing visits, researchers will ask questions related to tobacco use and craving, and collect urine and breath samples for further study.
- Participants will have two follow-up visits, 1 week and 2 weeks after the TMS sessions, to evaluate memory and mood, and will have one final MRI brain scan at the end of the study.
Read the detailed description
Primary objective: Transcranial magnetic stimulation (TMS) provides a non-invasive means of inhibiting brain neural activity. This pilot study will test whether 5 days of single pulse (sp) TMS reduces cue-induced nicotine craving and use in cigarette smokers.
Hypothesis: We predict that active spTMS will significantly lower craving for nicotine compared with sham spTMS.
Study population: Subjects will be up to 73 adult cigarette smokers (averaging greater than or equal to 10 cigarettes daily for greater than or equal to one year) with current nicotine dependence (based on DSM-IV criteria or Faerstrom Test for Nicotine Dependence score greater than or equal to 3). Subjects will not have other current major psychiatric disorders or substance abuse. Subjects in the pilot phase (one fMRI and one TMS session to valid brain mapping procedures) will be up to 25 healthy non-smokers.
Design: Following a baseline day to evaluate subject characteristics, subjects will be randomly assigned to receive 5 days of active or sham spTMS session. spTMS at strength 120 percent of the motor threshold will be applied to the prefrontal cortex (PFC) using a figure-eight coil. Magnetic pulses will be triggered by cigarette-related pictorial cues and delivered at varying intervals prior to presentation of a cigarette-related picture. TMS pulses will not be delivered during emotionally salient images unrelated to nicotine or emotionally neutral images. Brain site localization will use a computerized navigation system based on functional and structural MRI scans obtained before the first session. Each session (lasting around 20 minutes) will consist of 108 trials (cue presentations): 72 with nicotine-associated cues and 18 each with non-drug-associated positive or neutral cues. Subjects return for follow-up fMRI and behavioral assessments one and two weeks after the final TMS session.
Outcome measures: The primary outcome measure will be nicotine craving assessed with the Tobacco Craving Questionnaire and visual analog scales before and after every TMS session and at one- and two-week follow-up. Secondary outcome measures will include cigarette smoking over the test period and at follow-up assessed by self-report, salivary cotinine levels, and expired breath CO levels. A follow-up fMRI will evaluate changes in regional brain activity associated with changes in craving and TMS treatments.
Benefits: Participants will not directly benefit from this study. This study may contribute to better scientific understanding of nicotine addiction and development of better treatment methods.
Risks: The primary risks from TMS are transient headache, scalp discomfort, and hearing loss (minimized by wearing ear plugs). Seizures are very rare when spTMS is administered within accepted safety guidelines and individuals at increased risk of seizures are excluded. By excluding individuals with a history of non-drug-induced mania/ hypomania we minimize the risk of inducing a manic episode.
- Conditions
- Nicotine Dependence
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- Nicotine, Cigarettes, Tobacco, Transcranial Magnetic Stimulation (TMS), Cue-Induced Craving, Smoking
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
daily sessions for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Active TMS Receives: Device: Transcranial Magnetic Stimulation |
| Group B | Sham comparator | Sham TMS Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine craving by Tobacco Craving Questionnaire and visual-analogue scales.
Measured: 2 weeks
Secondary outcomes (1)
Cigarette use by self-report, salivary cotinine level, and expired breath CO levels.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study start13 Jul 2009
- Primary completion28 Aug 2013
- Study completion28 Aug 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Maryland
- Investigators
- David A Gorelick, M.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031693
- Sponsor's protocol ID
- 999909440
- Other IDs
- 09-DA-N440
- Status last verified
- 28 Aug 2013
- First submitted
- 11 Dec 2009
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Allen EA, Pasley BN, Duong T, Freeman RD. Transcranial magnetic stimulation elicits coupled neural and hemodynamic consequences. Science. 2007 Sep 28;317(5846):1918-21. doi: 10.1126/science.1146426.
PubMed 17901333BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PubMed 13688369Bestmann S, Baudewig J, Siebner HR, Rothwell JC, Frahm J. Functional MRI of the immediate impact of transcranial magnetic stimulation on cortical and subcortical motor circuits. Eur J Neurosci. 2004 Apr;19(7):1950-62. doi: 10.1111/j.1460-9568.2004.03277.x.
PubMed 15078569
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Transcranial Magnetic Stimulation (TMS) in Nicotine Addiction
- ClinicalTrials.gov ID
- NCT01031693
- Acronym / sponsor ID
- 999909440
- Conditions
- Nicotine Dependence
- Keywords
- Nicotine, Cigarettes, Tobacco, Transcranial Magnetic Stimulation (TMS), Cue-Induced Craving, Smoking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- University of Maryland
- Study start
- 13 Jul 2009
- Primary completion
- 28 Aug 2013 (actual)
- Study completion
- 28 Aug 2013 (actual)
- First posted
- 14 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:
- Treatment for nicotine addiction is characterized by high rates of relapse. New treatment therapies for nicotine addiction are exploring the use of brain scanning equipment to control and decrease nicotine and cigarette cravings.
- Transcranial magnetic stimulation (TMS) uses magnetic pulses to stimulate the brain. These pulses can change activity in parts of the brain. Researchers are interested in determining whether TMS delivered in single pulses can decrease activity in the parts of the brain that respond to nicotine craving.
Objectives:
- To determine whether single pulse TMS can reduce cue-induced nicotine craving and use in cigarette smokers.
Eligibility:
- Individuals 18 years of age and older who are physically healthy and have smoked 10 or more cigarettes per day for at least 1 year.
- A small group of healthy nonsmoking control subjects 18 years of age and older will also participate in the study.
Design:
- The study will involve seven study visits and two follow-up visits. The control participants will have only two visits: one with a magnetic resonance imaging (MRI) scan and one with TMS to evaluate brain function and response.
- Participants will have an initial assessment about tobacco use habits and craving patterns, and will provide blood and urine samples before beginning the study.
- Participants will have two initial MRI brain scans. The first scan will look at the structure of the brain at rest. During the other scan, participants will look at images related to and not related to cigarette smoking.
- The single pulse TMS sessions (with either actual TMS or inactive [sham] TMS) will be held daily for 5 consecutive days. Magnetic pulses will be triggered by cigarette-related picture cues and delivered at varying intervals before the participant sees a cigarette-related picture. During these testing visits, researchers will ask questions related to tobacco use and craving, and collect urine and breath samples for further study.
- Participants will have two follow-up visits, 1 week and 2 weeks after the TMS sessions, to evaluate memory and mood, and will have one final MRI brain scan at the end of the study.
Detailed description
Primary objective: Transcranial magnetic stimulation (TMS) provides a non-invasive means of inhibiting brain neural activity. This pilot study will test whether 5 days of single pulse (sp) TMS reduces cue-induced nicotine craving and use in cigarette smokers.
Hypothesis: We predict that active spTMS will significantly lower craving for nicotine compared with sham spTMS.
Study population: Subjects will be up to 73 adult cigarette smokers (averaging greater than or equal to 10 cigarettes daily for greater than or equal to one year) with current nicotine dependence (based on DSM-IV criteria or Faerstrom Test for Nicotine Dependence score greater than or equal to 3). Subjects will not have other current major psychiatric disorders or substance abuse. Subjects in the pilot phase (one fMRI and one TMS session to valid brain mapping procedures) will be up to 25 healthy non-smokers.
Design: Following a baseline day to evaluate subject characteristics, subjects will be randomly assigned to receive 5 days of active or sham spTMS session. spTMS at strength 120 percent of the motor threshold will be applied to the prefrontal cortex (PFC) using a figure-eight coil. Magnetic pulses will be triggered by cigarette-related pictorial cues and delivered at varying intervals prior to presentation of a cigarette-related picture. TMS pulses will not be delivered during emotionally salient images unrelated to nicotine or emotionally neutral images. Brain site localization will use a computerized navigation system based on functional and structural MRI scans obtained before the first session. Each session (lasting around 20 minutes) will consist of 108 trials (cue presentations): 72 with nicotine-associated cues and 18 each with non-drug-associated positive or neutral cues. Subjects return for follow-up fMRI and behavioral assessments one and two weeks after the final TMS session.
Outcome measures: The primary outcome measure will be nicotine craving assessed with the Tobacco Craving Questionnaire and visual analog scales before and after every TMS session and at one- and two-week follow-up. Secondary outcome measures will include cigarette smoking over the test period and at follow-up assessed by self-report, salivary cotinine levels, and expired breath CO levels. A follow-up fMRI will evaluate changes in regional brain activity associated with changes in craving and TMS treatments.
Benefits: Participants will not directly benefit from this study. This study may contribute to better scientific understanding of nicotine addiction and development of better treatment methods.
Risks: The primary risks from TMS are transient headache, scalp discomfort, and hearing loss (minimized by wearing ear plugs). Seizures are very rare when spTMS is administered within accepted safety guidelines and individuals at increased risk of seizures are excluded. By excluding individuals with a history of non-drug-induced mania/ hypomania we minimize the risk of inducing a manic episode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Transcranial Magnetic StimulationActive TMS |
| Group B | Sham comparator | Device: Transcranial Magnetic StimulationSham TMS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Personal or first-degree family history of any clinically defined neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness.
- Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head that cannot be safely removed.
- Metal shrapnel or bullet in the head or body including metal shavings.
- Current use of any investigational drug or of any medications with anti or pro-convulsive action
- Increased intracranial pressure (lowers seizure threshold)
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 |
|---|---|---|
| Transcranial Magnetic Stimulationdaily sessions for 5 days | Device | Group A, Group B |
Primary outcome
Nicotine craving by Tobacco Craving Questionnaire and visual-analogue scales.
Time frame: 2 weeks
1 secondary outcome
Cigarette use by self-report, salivary cotinine level, and expired breath CO levels.
Time frame: 2 weeks
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 5 Apr 2018.
- Background: PubMed 17901333Allen EA, Pasley BN, Duong T, Freeman RD. Transcranial magnetic stimulation elicits coupled neural and hemodynamic consequences. Science. 2007 Sep 28;317(5846):1918-21. doi: 10.1126/science.1146426.
- Background: PubMed 13688369BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- Background: PubMed 15078569Bestmann S, Baudewig J, Siebner HR, Rothwell JC, Frahm J. Functional MRI of the immediate impact of transcranial magnetic stimulation on cortical and subcortical motor circuits. Eur J Neurosci. 2004 Apr;19(7):1950-62. doi: 10.1111/j.1460-9568.2004.03277.x.
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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.
David A Gorelick, M.D. principal investigator
National Institute on Drug Abuse (NIDA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transcranial Magnetic Stimulation in people with Nicotine Dependence, run by National Institute on Drug Abuse (NIDA) at 2 sites 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 0 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 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Nicotine craving by Tobacco Craving Questionnaire and visual-analogue scales. (time frame: 2 weeks). 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 NCT01031693, 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 5 Apr 2018.