Accelerated rTMS for the Reduction of Nicotine Craving

NCT ID: NCT03352609

Last Updated: 2019-10-15

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-12-12

Brief Summary

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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

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Conditions

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Nicotine Use Disorder Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double blind, control
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Randomized double blind control using a sham rTMS system

Study Groups

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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.

Group Type EXPERIMENTAL

Active rTMS with MagVenture MagPro double blind rTMS system

Intervention Type DEVICE

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

5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.

Group Type SHAM_COMPARATOR

Sham rTMS

Intervention Type DEVICE

Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads

Interventions

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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.

Intervention Type DEVICE

Sham rTMS

Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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David Friedrich

Resident Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Friedrich, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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MUSC Institute of Psychiatry

Charleston, South Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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00070449

Identifier Type: -

Identifier Source: org_study_id

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