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Accelerated rTMS for the Reduction of Nicotine Craving

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status

Terminated

Conditions

Nicotine Dependence
Nicotine Use Disorder

Treatments

Device: Sham rTMS
Device: Active rTMS with MagVenture MagPro double blind rTMS system

Study type

Interventional

Funder types

Other

Identifiers

NCT03352609
00070449

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

5 participants in 2 patient groups

Active rTMS
Experimental 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.
Treatment:
Device: Active rTMS with MagVenture MagPro double blind rTMS system
Sham
Sham Comparator group
Description:
5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.
Treatment:
Device: Sham rTMS

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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