Accelerated rTMS for the Reduction of Nicotine Craving

Nicotine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03352609
• Other study ID #: 00070449
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 12, 2018

Study information

• Verified date: October 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 12, 2018
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Nicotine Use Disorder
• Tobacco Use Disorder

Intervention

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

Locations

Country	Name	City	State
United States	MUSC Institute of Psychiatry	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day (single visit)
Primary	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.	During the one day visit
Secondary	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.	1 week and 2 weeks after rTMS