Smoking CessationrTMSNCT02822703
Enhancing Relapse Prevention for Smoking Cessation With Repetitive Transcranial Magnetic Stimulation
A study testing rTMS Active 20Hz in people with Smoking Cessation, run by The City College of New York at 1 site in United States.
Trial summary
Tobacco use is one of the most significant cancer control and public health challenges in the US today. Half of all smokers in the US will attempt to quit tobacco each year, but fully 95% of those who attempt to quit will reverse this decision within 12 months and choose the transient, albeit immediately rewarding… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- rTMS Active 20Hz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jun 2016
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21-65 years old
- Are fluent in English and be able to read English at the 8th grade level
- Pass the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire (TASS)
- Report smoking 5-20 cigarettes daily
- Intend to quit smoking in the next 30 days
- Report a motivation level to quit of ≥7 (scale 0-10)
- Pass a urine drug screen for drugs of abuse (marijuana, cocaine, opioids, amphetamines, etc.)
- No plans to move from the area NYC area in the next 4 months and have a consistent, reliable method of communication so that study staff can successfully contact them
Who cannot join
- self-reported claustrophobia
- personal history of epilepsy
- use of anticonvulsant medication
- head injury, aneurysm, stroke, or previous cranial neurosurgery
- diagnosis of major depressive disorder, bipolar disorder, a schizophrenia-spectrum disorder, tinnitus, or migraines
- metal implants in the head, neck, or cochlea; a pacemaker
Show all 11Show fewer
- currently taking medications that lower seizure threshold (i.e., such as tricyclic antidepressants or bupropion)
- known pre-existing noise induced hearing loss or concurrent treatment of ototoxic medications (i.e., Aminoglycosides, Cisplatine)
- currently using medications for tobacco cessation (i.e., nicotine replacement, bupropion, varenicline, etc.)
- pregnant or planning to become pregnant in the next 12 weeks
- current regular use of forms of tobacco other than cigarettes
Trial locations and contacts
1 site in 1 country.
United States1 site
The City College of New York
New York, New York, 10031
About this study
Official title: Enhancing Relapse Prevention for Smoking Cessation With Repetitive Transcranial Magnetic Stimulation (rTMS)
Tobacco use is one of the most significant cancer control and public health challenges in the US today. Half of all smokers in the US will attempt to quit tobacco each year, but fully 95% of those who attempt to quit will reverse this decision within 12 months and choose the transient, albeit immediately rewarding activity of smoking at the cost of much larger long-term rewards such as future health and long life. This project seeks to improve scientific knowledge of these decision-making processes and potentially improve the treatment of tobacco dependence by examining the feasibility of using a brain stimulation technique, repetitive Transcranial Magnetic Stimulation or rTMS to improve the efficacy of an existing evidence-based relapse prevention intervention. rTMS is an FDA-cleared treatment for medication resistant depression and is being examined as a treatment for a variety of other disorders. This study will utilize an intensity and duration of rTMS that is well within the safety parameters and similar in location and intensity to that used in previous studies with smokers to reduce cigarette consumption.
Read the detailed description
This project seeks to improve scientific knowledge of the decision-making processes of smokers and improve tobacco dependence treatments. The dorsolateral prefrontal cortex (DLPFC) influences decision-making by integrating inhibitory mechanisms with emotionally charged information from limbic regions, thereby exerting an inhibitory influence on seductive, immediately rewarding options with long-term costs, such as smoking. Delay discounting is the degree to which one de-values delayed outcomes, such as future health and long life. Converging evidence indicates that choosing a delayed option with a larger reward is associated with increased activity in the DLPFC. This study proposes that choosing to smoke after making a decision to quit reflects a situation where the DLPFC is insufficiently activated to exert an inhibitory influence on the immediately rewarding option of smoking.
Preliminary studies indicate that stimulation of the DLPFC with 20 Hz high frequency repetitive Transcranial Magnetic Stimulation (rTMS) reduces delay discounting (i.e., causes individuals to choose delayed, higher value options); reduces cigarette consumption in smokers intending to quit; improves executive function, learning, memory, and attention; is a promising adjunct to cognitive-behavioral treatment of other disorders; and is likely to improve the efficacy of existing cognitive-behavioral treatments for tobacco dependence.
The goal of this study is to make an informed recommendation, based on measures of feasibility, of whether or not this intervention should be tested for efficacy. A double blind, randomized between-subjects treatment (active or sham) design will be employed in which all subjects are exposed to the same relapse prevention materials during rTMS stimulation.
Aim 1: Examine the feasibility of combining high frequency rTMS with an evidence-based, self-help, cognitive-behavioral relapse prevention intervention using multiple feasibility indicators (demand, acceptability, practicality, limited-efficacy testing, and adequate blinding).
Aim 2: Examine differences in delay discounting between the active and the sham conditions 2, 4, 8, and 12 weeks after the quit day.
Aim 3: Use latency to relapse comparisons to calculate estimates of the effect size of this intervention on abstinence.
- Conditions
- Smoking Cessation
- Being tested
- rTMS Active 20Hz, rTMS Sham
- Keywords
- smoking cessation, tobacco use disorder, delay discounting, repetitive transcranial magnetic stimulation, relapse prevention
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS Active 20HzDevice
Active stimulation will be delivered with 70mm Double Air Film Coils. Participants will attend eight 20Hz sessions within two weeks of the scheduled quit date. Participants will receive 20Hz at 110% of the MT for 1 second, less than the limits indicated in the guidelines. These stimulation parameters have been utilized with no serious adverse events in previous studies to decrease delay discounting among smokers and non-smokers. These parameters are similar to or less intense than those utilized in other smoking cessation studies. All participants will receive rTMS over the same area of the DLPFC (6cm anterior to the MT area) while reading relapse prevention booklets supervised by the study coordinator.
rTMS ShamDevice
The sham stimulation uses a similar 70mm Double Air Film Coil to look and sound like the active coil, but the magnetic field produced by the sham coil is markedly attenuated (only 5% of stimulator output setting: that is 2.25% of the maximum stimulator output (5% of 45% = 2.25%) and biologically inactive. Participants in this condition will attend eight sham sessions within two weeks of their scheduled quit date. During these sessions, they will also read relapse prevention booklets supervised by the study coordinator. The sham coil is not intended to and does not produce a stimulation effect so there is no proposed biologic mechanism of action.
| Study group | Role | What they receive |
|---|---|---|
| Active 20Hz | Experimental | The rTMS device used in this study is the Mastim Super Rapid2 Stimulator with a 70mm Double Air Film Coil. Guidelines indicate that the maximum safe duration of a single train of 20Hz at 110% of the Motor Threshold (MT) is 1.6 seconds. In this study, the stimulator and the coils will be used to stimulate neurons in the left dorsolateral prefrontal cortex (DLPFC), the same location in the brain as that stimulated in the studies supporting the efficacy of this treatment in depression, in order to examine the feasibility of testing this intervention for efficacy in the treatment of tobacco dependence. Receives: Device: rTMS Active 20Hz |
| Sham | Sham comparator | The rTMS sham coil used in this study is manufactured by Magstim and currently classified as an investigational device. There is no intention to treat or prevent a disease and/or alter a function in the body with the sham stimulation provided by the sham coil. In this project, the sham coil will be placed in the same location in the brain as that stimulated in the studies supporting the efficacy of this treatment for depression. Receives: Device: rTMS Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency to relapse
Abstinence will be assessed with latency to relapse (days from Quit Date to relapse or 7 consecutive days of smoking after a 24 hour quit attempt)
Measured: 3.5 months following scheduled quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- The City College of New York
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Virginia Tech Carilion School of Medicine and Research Institute
- Responsible party
- Principal investigator, Christine Sheffer, The City College of New York
- Investigators
- Christine E Sheffer, PhD, Principal investigator, CCNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822703
- Sponsor's protocol ID
- 639308
- Other IDs
- R21CA178813
- Acronym
- rTMS
- Status last verified
- Jun 2016
- First submitted
- 30 Jun 2016
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Relapse Prevention for Smoking Cessation With Repetitive Transcranial Magnetic Stimulation (rTMS)
- ClinicalTrials.gov ID
- NCT02822703
- Acronym / sponsor ID
- rTMS / 639308
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, tobacco use disorder, delay discounting, repetitive transcranial magnetic stimulation, relapse prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- The City College of New YorkUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Virginia Tech Carilion School of Medicine and Research Institute
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Jul 2016 (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.
Tobacco use is one of the most significant cancer control and public health challenges in the US today. Half of all smokers in the US will attempt to quit tobacco each year, but fully 95% of those who attempt to quit will reverse this decision within 12 months and choose the transient, albeit immediately rewarding activity of smoking at the cost of much larger long-term rewards such as future health and long life. This project seeks to improve scientific knowledge of these decision-making processes and potentially improve the treatment of tobacco dependence by examining the feasibility of using a brain stimulation technique, repetitive Transcranial Magnetic Stimulation or rTMS to improve the efficacy of an existing evidence-based relapse prevention intervention. rTMS is an FDA-cleared treatment for medication resistant depression and is being examined as a treatment for a variety of other disorders. This study will utilize an intensity and duration of rTMS that is well within the safety parameters and similar in location and intensity to that used in previous studies with smokers to reduce cigarette consumption.
Detailed description
This project seeks to improve scientific knowledge of the decision-making processes of smokers and improve tobacco dependence treatments. The dorsolateral prefrontal cortex (DLPFC) influences decision-making by integrating inhibitory mechanisms with emotionally charged information from limbic regions, thereby exerting an inhibitory influence on seductive, immediately rewarding options with long-term costs, such as smoking. Delay discounting is the degree to which one de-values delayed outcomes, such as future health and long life. Converging evidence indicates that choosing a delayed option with a larger reward is associated with increased activity in the DLPFC. This study proposes that choosing to smoke after making a decision to quit reflects a situation where the DLPFC is insufficiently activated to exert an inhibitory influence on the immediately rewarding option of smoking.
Preliminary studies indicate that stimulation of the DLPFC with 20 Hz high frequency repetitive Transcranial Magnetic Stimulation (rTMS) reduces delay discounting (i.e., causes individuals to choose delayed, higher value options); reduces cigarette consumption in smokers intending to quit; improves executive function, learning, memory, and attention; is a promising adjunct to cognitive-behavioral treatment of other disorders; and is likely to improve the efficacy of existing cognitive-behavioral treatments for tobacco dependence.
The goal of this study is to make an informed recommendation, based on measures of feasibility, of whether or not this intervention should be tested for efficacy. A double blind, randomized between-subjects treatment (active or sham) design will be employed in which all subjects are exposed to the same relapse prevention materials during rTMS stimulation.
Aim 1: Examine the feasibility of combining high frequency rTMS with an evidence-based, self-help, cognitive-behavioral relapse prevention intervention using multiple feasibility indicators (demand, acceptability, practicality, limited-efficacy testing, and adequate blinding).
Aim 2: Examine differences in delay discounting between the active and the sham conditions 2, 4, 8, and 12 weeks after the quit day.
Aim 3: Use latency to relapse comparisons to calculate estimates of the effect size of this intervention on abstinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active 20Hz | Experimental | Device: rTMS Active 20HzThe rTMS device used in this study is the Mastim Super Rapid2 Stimulator with a 70mm Double Air Film Coil. Guidelines indicate that the maximum safe duration of a single train of 20Hz at 110% of the Motor Threshold (MT) is 1.6 seconds. In this study, the stimulator and the coils will be used to stimulate neurons in the left dorsolateral prefrontal cortex (DLPFC), the same location in the brain as that stimulated in the studies supporting the efficacy of this treatment in depression, in order to examine the feasibility of testing this intervention for efficacy in the treatment of tobacco dependence. |
| Sham | Sham comparator | Device: rTMS ShamThe rTMS sham coil used in this study is manufactured by Magstim and currently classified as an investigational device. There is no intention to treat or prevent a disease and/or alter a function in the body with the sham stimulation provided by the sham coil. In this project, the sham coil will be placed in the same location in the brain as that stimulated in the studies supporting the efficacy of this treatment for depression. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 21-65 years old
- Are fluent in English and be able to read English at the 8th grade level
- Pass the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire (TASS)
- Report smoking 5-20 cigarettes daily
- Intend to quit smoking in the next 30 days
Key exclusion criteria (11 listed)
- self-reported claustrophobia
- personal history of epilepsy
- use of anticonvulsant medication
- head injury, aneurysm, stroke, or previous cranial neurosurgery
- diagnosis of major depressive disorder, bipolar disorder, a schizophrenia-spectrum disorder, tinnitus, or migraines
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 |
|---|---|---|
| rTMS Active 20HzActive stimulation will be delivered with 70mm Double Air Film Coils. Participants will attend eight 20Hz sessions within two weeks of the scheduled quit date. Participants will receive 20Hz at 110% of the MT for 1 second, less than the limits indicated in the guidelines. These stimulation parameters have been utilized with no serious adverse events in previous studies to decrease delay discounting among smokers and non-smokers. These parameters are similar to or less intense than those utilized in other smoking cessation studies. All participants will receive rTMS over the same area of the DLPFC (6cm anterior to the MT area) while reading relapse prevention booklets supervised by the study coordinator. | Device | Active 20Hz |
| rTMS ShamThe sham stimulation uses a similar 70mm Double Air Film Coil to look and sound like the active coil, but the magnetic field produced by the sham coil is markedly attenuated (only 5% of stimulator output setting: that is 2.25% of the maximum stimulator output (5% of 45% = 2.25%) and biologically inactive. Participants in this condition will attend eight sham sessions within two weeks of their scheduled quit date. During these sessions, they will also read relapse prevention booklets supervised by the study coordinator. The sham coil is not intended to and does not produce a stimulation effect so there is no proposed biologic mechanism of action. | Device | Sham |
Primary outcome
Latency to relapse
Time frame: 3.5 months following scheduled quit date
Abstinence will be assessed with latency to relapse (days from Quit Date to relapse or 7 consecutive days of smoking after a 24 hour quit attempt)
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 4 Jul 2016.
- Individual participant dataSharing planned: No
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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.
Christine E Sheffer, PhD principal investigator
CCNY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS Active 20Hz in people with Smoking Cessation, run by The City College of New York 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 8 inclusion and 11 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 4 Jul 2016. 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. 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.
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?
Latency to relapse (time frame: 3.5 months following scheduled quit date). 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 4 Jul 2016.