Accelerated rTMS for the Reduction of Nicotine Craving

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03352609
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nicotine Use Disorder; Nicotine Dependence	Device: Active rTMS with MagVenture MagPro double blind rTMS system; Device: Sham rTMS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, double blind, controlRandomized, double blind, control
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Randomized double blind control using a sham rTMS system
• Primary Purpose: Treatment
• Official Title: Accelerated Repetitive Transcranial Magnetic Stimulation (rTMS) of the Dorsolateral Prefrontal Cortex for the Reduction of Craving in Nicotine Dependent Individuals
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Dec 12, 2018
• Actual Study Completion Date: Dec 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active rTMS 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.	Device: Active rTMS with MagVenture MagPro double blind rTMS system; 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 Comparator: Sham 5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.	Device: Sham rTMS; Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads

Outcome Measures

Primary Outcome Measures

1. Tolerability Measured by Percent of Participants Completing the rTMS Course [1 day (single visit)]

   Percent of participants completing the 5 session rTMS course. Hypothesize >75% of participants will complete the 5 treatments.

2. Decrease in Cue Induced Nicotine Craving [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.

Secondary Outcome Measures

1. Reduce in Self Reported Smoking [1 week and 2 weeks after rTMS]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria

• 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.

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MUSC Institute of Psychiatry	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina

Investigators

• Principal Investigator: David Friedrich, MD, Medical University of South Carolina

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 30, 2018

More Information

Publications

None provided.

• Responsible Party: David Friedrich, Resident Physician, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT03352609
• Other Study ID Numbers: 00070449
• First Posted: Nov 24, 2017
• Last Update Posted: Oct 15, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by David Friedrich, Resident Physician, Medical University of South Carolina: TMS; rTMS; Transcranial Magnetic Stimulation; Smoking; Nicotine
• Additional relevant MeSH terms: Tobacco Use Disorder

Study Results

Participant Flow

Arm/Group Title	Active rTMS	Sham
Arm/Group Description	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. Active rTMS with MagVenture MagPro double blind rTMS system: 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.	5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention. Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads
Period Title: Overall Study
STARTED	2	3
COMPLETED	2	3
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Active rTMS	Sham	Total
Arm/Group Description	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. Active rTMS with MagVenture MagPro double blind rTMS system: 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.	5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention. Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads	Total of all reporting groups
Overall Participants	2	3	5
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 100%	3 100%	5 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	2 100%	3 100%	5 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%	3 100%	5 100%

Outcome Measures

1. Primary Outcome

Title	Tolerability Measured by Percent of Participants Completing the rTMS Course
Description	Percent of participants completing the 5 session rTMS course. Hypothesize >75% of participants will complete the 5 treatments.
Time Frame	1 day (single visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active rTMS	Sham
Arm/Group Description	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. Active rTMS with MagVenture MagPro double blind rTMS system: 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.	5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention. Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads
Measure Participants	2	3
Count of Participants [Participants]	2 100%	3 100%

2. Primary Outcome

Title	Decrease in Cue Induced Nicotine Craving
Description	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.
Time Frame	During the one day visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active rTMS	Sham
Arm/Group Description	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. Active rTMS with MagVenture MagPro double blind rTMS system: 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.	5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention. Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads
Measure Participants	2	3
Mean (Full Range) [Percent change on craving scale]	-4.65	-7.6

3. Secondary Outcome

Title	Reduce in Self Reported Smoking
Description	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.
Time Frame	1 week and 2 weeks after rTMS

Outcome Measure Data

Analysis Population Description

Participants did not return follow up phone call

Arm/Group Title	Active rTMS	Sham
Arm/Group Description	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. Active rTMS with MagVenture MagPro double blind rTMS system: 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.	5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention. Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads
Measure Participants	0	0

Adverse Events

Time Frame	Single visit of approximately 6 hours
Arm/Group Title	Active rTMS		Sham
Arm/Group Description	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. Active rTMS with MagVenture MagPro double blind rTMS system: 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.		5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention. Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads
All Cause Mortality
	Active rTMS		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)
Serious Adverse Events
	Active rTMS		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Active rTMS		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		1/3 (33.3%)
General disorders
Mild Nausea	0/2 (0%)		1/3 (33.3%)
Skin and subcutaneous tissue disorders
Slight scalp discomfort	1/2 (50%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.