Accelerated rTMS for the Reduction of Nicotine Craving

Not Applicable

Terminated

• Conditions: Nicotine Dependence; Nicotine Use Disorder
• Interventions: Device: Active rTMS with MagVenture MagPro double blind rTMS system; Device: Sham rTMS

• Registration Number: NCT03352609
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-24
• Study Start: 2018-01-01
• Primary Completion: 2018-12-12
• Study Completion: 2018-12-12
• Results First Submitted: 2019-09-20
• Results First Submitted QC: 2019-09-20
• Status Verified: 2019-10
• Results First Posted: 2019-10-08
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active rTMS	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	Sham rTMS	5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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.

Trial Locations

Locations (1)

MUSC Institute of Psychiatry; 🇺🇸 Charleston, South Carolina, United States