Nicotine Use DisorderNCT03352609

Accelerated rTMS for the Reduction of Nicotine Craving

A study testing Active rTMS with MagVenture MagPro double blind rTMS system in people with Nicotine Use Disorder and Nicotine Dependence, run by Medical University of South Carolina at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose if this study is to determine if five treatments of repetitive transcranial magnetic stimulation (rTMS) can reduce craving for cigarettes in smokers. rTMS uses magnetic pulses to stimulate the brain and is currently approved for the treatment of major depressive disorder. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Nicotine Use Disorder, Nicotine Dependence
What is being tested?: Active rTMS with MagVenture MagPro double blind rTMS system
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2018to 12 Dec 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Outpatient Adults aged 18-70
Cigarette Smokers smoking at least 1 pack (20 cigarettes a day) with current smoking status confirmed by exhaled CO reading of >10ppm day of visit.
Ability to provide informed consent

Who cannot join

Current treatment with varenicline or bupropion
Currently making a smoking quit attempt (not currently smoking).
Current treatment with an antidepressant, anti-convulsant, anxiolytic, antipsychotic or mood stabilizer.
Current episode of major depression determined by MINI interview.
Current or past history of schizophrenia, schizoaffective disorder, anorexia nervosa, bulimia or bipolar disorder as determined by MINI.
Current daily consumption of alcohol or current alcohol use disorder.

Show all 12Show fewer

Current substance use disorder except for nicotine or cannabis use disorder.
Currently pregnant or lactating.
Contraindications to rTMS including history of seizure, metal implanted above the neck, pacemaker or any brain lesion.
Unstable medical conditions
Suicidal ideation or history of suicide attempt within the last six months.
Inability or unwillingness of subject or legal guardian/representative to give informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

MUSC Institute of Psychiatry
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Accelerated Repetitive Transcranial Magnetic Stimulation (rTMS) of the Dorsolateral Prefrontal Cortex for the Reduction of Craving in Nicotine Dependent Individuals

Conditions: Nicotine Use Disorder, Nicotine Dependence
Being tested: Active rTMS with MagVenture MagPro double blind rTMS system, Sham rTMS
Keywords: TMS, rTMS, Transcranial Magnetic Stimulation, Smoking, Nicotine
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.

Active rTMS with MagVenture MagPro double blind rTMS systemDevice
5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
Sham rTMSDevice
Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads

Study groups in NCT03352609
Study group	Role	What they receive
Active rTMS	Experimental	5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session. Receives: Device: Active rTMS with MagVenture MagPro double blind rTMS system
Sham	Sham comparator	5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention. Receives: Device: Sham rTMS

What is being measured

The primary outcome is the main question the study is designed to answer.

Tolerability Measured by Percent of Participants Completing the rTMS Course
Percent of participants completing the 5 session rTMS course. Hypothesize >75% of participants will complete the 5 treatments.
Measured: 1 day (single visit)
Decrease in Cue Induced Nicotine Craving
Nicotine craving evaluated using Questionnaire on Smoking Urges- Brief (QSU-B) questions modified to a 0-100 analog rating. Higher scores meaning a higher level of craving.
Measured: During the one day visit

Secondary outcomes (1)

Reduce in Self Reported Smoking
An exploratory outcome will be the determination if participants receiving active rTMS report decreased levels of smoking 1 week and 2 weeks after rTMS course.
Measured: 1 week and 2 weeks after rTMS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201812 Dec 2018

First posted24 Nov 2017
Study start1 Jan 2018
Primary completion12 Dec 2018
Study completion12 Dec 2018

Why it stopped: Investigator completing residency program and leaving for a new job

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Nicotine Use DisorderStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
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
Model description: Randomized, double blind, control
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03352609
Sponsor's protocol ID: 00070449
Status last verified: Oct 2019
First submitted: 8 Nov 2017
Last updated: 15 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product

All Nicotine Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Accelerated Repetitive Transcranial Magnetic Stimulation (rTMS) of the Dorsolateral Prefrontal Cortex for the Reduction of Craving in Nicotine Dependent Individuals
ClinicalTrials.gov ID: NCT03352609
Acronym / sponsor ID: 00070449
Conditions: Nicotine Use Disorder, Nicotine Dependence
Keywords: TMS, rTMS, Transcranial Magnetic Stimulation, Smoking, Nicotine
Study type: Interventional
Recruitment status: TerminatedReason stopped: Investigator completing residency program and leaving for a new job
Enrolment: 5 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: 1 Jan 2018 (actual)
Primary completion: 12 Dec 2018 (actual)
Study completion: 12 Dec 2018 (actual)
First posted: 24 Nov 2017 (actual)
Results: Posted 8 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized, double blind, control

Arm	Type	Receives
Active rTMS	Experimental	Device: Active rTMS with MagVenture MagPro double blind rTMS system5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
Sham	Sham comparator	Device: Sham rTMS5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Outpatient Adults aged 18-70
Cigarette Smokers smoking at least 1 pack (20 cigarettes a day) with current smoking status confirmed by exhaled CO reading of >10ppm day of visit.
Ability to provide informed consent

Key exclusion criteria (12 listed)

Current treatment with varenicline or bupropion
Currently making a smoking quit attempt (not currently smoking).
Current treatment with an antidepressant, anti-convulsant, anxiolytic, antipsychotic or mood stabilizer.
Current episode of major depression determined by MINI interview.
Current or past history of schizophrenia, schizoaffective disorder, anorexia nervosa, bulimia or bipolar disorder as determined by MINI.

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
Active rTMS with MagVenture MagPro double blind rTMS system5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.	Device	Active rTMS
Sham rTMSDouble blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads	Device	Sham

Primary outcome

Tolerability Measured by Percent of Participants Completing the rTMS Course
Time frame: 1 day (single visit)
Percent of participants completing the 5 session rTMS course. Hypothesize >75% of participants will complete the 5 treatments.
Decrease in Cue Induced Nicotine Craving
Time frame: During the one day visit
Nicotine craving evaluated using Questionnaire on Smoking Urges- Brief (QSU-B) questions modified to a 0-100 analog rating. Higher scores meaning a higher level of craving.

1 secondary outcome

Reduce in Self Reported Smoking
Time frame: 1 week and 2 weeks after rTMS

Results and safety

Results posted to the registry on 8 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active rTMS	2	2
Sham	3	3

Primary outcome: Tolerability Measured by Percent of Participants Completing the rTMS Course

Time frame: 1 day (single visit). Count of participants. Unit: Participants

Measure	Active rTMS n = 2	Sham n = 3
Value	2	3

Primary outcome: Decrease in Cue Induced Nicotine Craving

Time frame: During the one day visit. Mean (Full Range). Unit: Percent change on craving scale

Measure	Active rTMS n = 2	Sham n = 3
Value	-4.65 (-10 to 0.7)	-7.6 (-21.3 to 3.3)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Single visit of approximately 6 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active rTMS	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Sham	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Nicotine Use Disorder

Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product

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 Friedrich, MD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 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: stopped early, as of the sponsor's last update on 15 Oct 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. 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?

Yes. Results are posted in the registry (first posted 8 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Tolerability Measured by Percent of Participants Completing the rTMS Course (time frame: 1 day (single visit)). The study lists 2 primary outcomes in all. 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 NCT03352609.

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 15 Oct 2019.